Proprietà psicometriche del Wolf Motor Function Test (WMFT) e delle sue versioni modificate: una revisione sistematica con meta-analisi

Psychometric properties of the Wolf Motor Function Test (WMFT) and its modified versions: a systematic review with meta-analysis

Autori

Notturni Francesco [CRT, Clinica di Riabilitazione Toscana, Montevarchi (AR), Italy]

Ugolini Alessandro [Independent research, Empoli (FI), Italy]

Piscitelli Daniele [Department of Kinesiology, University of Connecticut, Storrs, CT, USA]

Pometti Lorena Sabrina [IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy]

Ferrarello Francesco [Unit of Functional Rehabilitation, Department of Allied Health Professions, Azienda USL Toscana Centro, Prato, Italy]

Coppari Andrea [Physical and Rehabilitation Medicine Unit, Azienda Sanitaria Territoriale, Jesi (AN), Italy]

Caselli Serena [Azienda Ospedaliero-Universitaria di Modena, Modena, Italy]

La Porta Fabio [IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy]

Pellicciari Leonardo [IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy]

Introduction

Individuals with stroke commonly experience upper extremity (UE) sensorimotor deficits, which impact quality of life. Deficits persist in about 80% of survivors. The Wolf Motor Function Test (WMFT, 17 items) is widely used to assess UE function post-stroke; it assesses both motor capacity (subscale, Functional Ability Scale [FAS]) and performance time (subscale, TIME). Additional versions of the WMFT have been proposed. The Graded WMFT (gWMFT, 13 items) was developed for the accurate assessment of moderate to severe UE impairment, and a short form version of WMFT, the Streamlined WMFT (sWMFT, 6 items), targeted people with stroke at different stages of recovery (subacute and chronic). To date, a comprehensive evaluation of the WMFT psychometric properties is lacking. Therefore, we aimed to perform a systematic review (SR) with meta-analysis to assess the reliability, validity, and responsiveness of the WMFT when utilized to assess individuals with stroke.

Methods

Six databases (i.e., MEDLINE, CINAHL, EMBASE, PsycINFO, CENTRAL, Web of Science) were searched to retrieve studies investigating WMFT psychometric properties, as defined by the COSMIN taxonomy domains. Two independent reviewers performed literature search, study selection, data extractions, and quality assessment (according to the COSMIN Risk of Bias checklist).To pool the data, we considered Cronbach’s alpha for internal consistency, the intraclass correlation coefficient (ICC), Cohen’s kappa, and weighted linear (or quadratic) kappa for intra- and inter-rater reliability. Measurement error was assessed by the standard error of measurement (SEM) and minimum detectable change (MDC). For construct validity, Pearson or Spearman correlation coefficients were examined. For responsiveness, effect size (ES) and standardized response mean (SRM) were considered. The level and grading of evidence were defined for each psychometric property according to the COSMIN modifed GRADE approach.

Results

Out of 4127 titles screened after removing the duplicates, 25 studies involving 2009 individuals with stroke were included in the SR, and 23 in the meta-analysis. Table 1 shows the pooled results. FAS and TIME WMFT’s subscales internal consistency (alpha≥0.88) intra- (ICC≥0.97) and inter-rater (ICC≥0.92) reliability, construct validity (strong correlation with Fugl-Meyer Assessment for upper limb [FMA-UL] and Action Research Arm Test [ARAT]), and responsiveness (ES≥0.48) were rated with quality of evidence ranging  from very low to high, as well as the structural validity of FAS and the measurement error of TIME subscales (Table 1). Measurement error for FAS was assessed as inconsistent with moderate quality of evidence. Cross-cultural validity was rated as indeterminate with very low quality of evidence. Content validity and structural validity for TIME were not assessed in the included studies. Pooled findings on gWMFT reliability and sWMFT responsiveness are showed in Table 1.

Discussion and Conclusion

Most studies focused on the WMFT, demonstrating its strong psychometric properties, while fewer explored the gWMFT and sWMFT. The SR provides valuable insights into the reliability, validity, and responsiveness of WMFT, supporting its clinical utility in individuals with stroke. The reliability of the WMFT is well-established for the FAS and the TIME subscales. Strong correlations with other established motor function assessments, such as the FMA-UL and ARAT, support construct validity. Few studies have evaluated the psychometric properties of the gWMFT and sWMFT; therefore, their reliability and validity are not well-established as those of the original WMFT. Studies that reaserched the sWMFT and gWMFT are promising, but the evidence for their psychometric properties is currently insufficient for widespread recommendation. Future research should focus on enhancing the content and cross-cultural validity of the WMFT, and the psychometric properties of WMFT’s modified versions.

REFERENCES

Gagnier JJ, Lai J, Mokkink LB, Terwee CB. COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures. Qual Life Res. 2021 Aug;30(8):2197-2218. doi: 10.1007/s11136-021-02822-4.

 

Wolf SL, Lecraw DE, Barton LA, Jann BB. Forced use of hemiplegic upper extremities to reverse the effect of learned nonuse among chronic stroke and head-injured patients. Exp Neurol. 1989 May;104(2):125-32. doi: 10.1016/s0014-4886(89)80005-6.

Approcci innovativi alla mobilità degli Studenti in Partenza nei Corsi di Laurea in Fisioterapia: uno studio comparativo dei Modelli Organizzativi nella Regione Veneto

Innovative approaches to Outgoing Student Mobility in Physiotherapy Degree Program: a comparative study of Organizational Models in the Veneto Region

Autori

Coppola Lucia [Physiotherapy Degree Course, Padua University, Padua, Italy]

Cecchin Enrica [Physiotherapy Degree Course, Verona University, Verona, Italy]

Quinci Antonio [Physiotherapy Degree Course, Padua University, Padua, Italy]

Marini Gabriella [Physiotherapy Degree Course, Padua University, Padua, Italy]

Introduction

The international process of Italian universities involves exchange student projects between foreign universities and Italian universities of the same study course. In the future, we will have foreign lecturers teaching in Italy and Italian lecturers teaching abroad. Currently, the most stable and widespread form of cultural exchange is the presence of foreign students for varying periods attending classes and internships in the Physiotherapy Degree Programs of universities with established collaborative relationships, known as partner universities.

The international projects that currently involve the two universities in Veneto, the University of Padua and the University of Verona, to which all six Physiotherapy Degree Program locations in Veneto are linked, are Erasmus Plus and Ulysses Overseas. The increasing number of students and the complexity of the educational and administrative processes in each university have necessitated the creation of a dedicated organizational model, which we have decided to present.

Methods

We describe the organizational models adopted by the two degree programs to manage outgoing students, excluding the phenomenon of incoming students, which is also present. The number of students, not divided by gender, who have actually departed (and not just won grants) from the 2021-2022 academic year to the allocations for the 2024-2025 academic year for earning curricular credits is recorded. Students who leave after graduation in the first post-graduation year are excluded, even though they still fall under student exchange projects but follow different administrative paths.

Results

The number of students involved is shown in Table 1. The various countries are shown in Table 2. This is followed by a description of the two organizational models.

The Verona Model:

The Physiotherapy Degree Program at the University of Verona is organized into three locations: Verona, Vicenza, and Rovereto (TN), accommodating a total of 240 students, with an intake of 25 students for the Vicenza and Rovereto (TN) branches and 30 students for the Verona branch. In their second year, students can participate in a call for the allocation of Erasmus mobility grants to complete part of their academic program abroad during the third year (ranging from 2 to 4 months, earning a minimum of 12 credits). Students can choose to attend courses at one of the partner university locations or engage in internships, obtaining recognition for the exams and credits earned. This educational opportunity is managed by the International Mobility Office, which reports to the Academic Services and Student Services Directorate. The service collaborates with the Faculty of Medicine’s Internationalization Delegate and an Erasmus Coordinator for all health professions, utilizing contacts for each degree program to manage Erasmus exchange activities with each partner university. For the Physiotherapy Degree Program, it has been decided to maintain the initial single Erasmus Contact, who is also the Coordinator of one of the three academic branches.

The Padua Model:

The Physiotherapy Degree Program at the University of Padua is organized into four locations: Venice, Padua, Schio (VI), and Conegliano (TV). The various locations have different student numbers, totaling 300 students across the first, second, and third years and four locations, all within the Veneto Region. Students participate in Ulysses or Erasmus calls while attending the second year, with departures allowed from the second semester of the third year, having acquired clinical skills to better understand the different working contexts they will encounter outside Italy. This way, they have earned credits for classroom lessons in Italy and will earn a minimum of 12 to a maximum of 18 credits related to internships abroad. In reality, the scholarships include one theoretical exam in conjunction with the internship, so winning students will enroll in a course abroad, attend this course, and complete the internship. However, having already completed classroom training gives students the freedom to attend a course worth 1 credit or more credits abroad, depending on the availability of the foreign location. From the 2023-2024 academic year, it has been possible to participate in a call to complete only the thesis abroad, for a total of 6 credits. Administrative aspects are managed by the International Mobility Office, which reports to the Academic Services and Student Services Directorate.

As an internal organizational model for the Degree Program, there is a Course Internationalization Contact and four persons in charge: each of them (one coordinator and three location tutors) maintains contacts with two foreign university partners. This way, winning students at a location refer to the person managing the foreign location, and over the years, the foreign location can build privileged relationships with a single person in charge.

Discussion and Conclusion

We can see positive aspects in both models. The Verona model is very linear, as all students, all foreign locations, and the International Mobility Office report to a single person for all exchanges. On the other hand, the workload is placed on a single person. The Padua model is more complex, involving four people, one for each location (Venice, Schio (VI), Conegliano (TV), and Padua), coordinated by the single Internationalization Project Contact for the Degree Program, but the commitment for each person in charge is less.

REFERENCES

https://www.unipd.it/en/erasmus-studies-out

https://www.univr.it/en/our-services/-/servizi/opportunities-abroad-for-students-and-staff

Ottimizzazione dell’attività fisioterapica nei Reparti di Area Medica dell’Azienda ospedaliero-universitaria Senese

Optimization of physiotherapy activity in the Medical Area Departments of the Azienda ospedaliero-universitaria Senese

Autori

Baldo Niccolò (Azienda ospedaliero-universitaria Senese – Strada delle Scotte, 14, 53100 – Siena (SI) – Italy)

Introduction

Disability rates are increasing worldwide (1, 2, 3) and the main aim of rehabilitation is to maximize functionality despite disability, impacting the quality of life of individuals and caregivers (1, 4). The extension of life causes an increase in hospitalizations in the Medical Area and, since these are mostly frail elderly people, therefore with increased vulnerability and limited functional reserve, stress factors such as hospitalization can also worsen any disability already present (5, 6). These characteristics determine the need to activate early physiotherapy management in the acute phase of hospitalization and highlight the need to optimize the use of the increasingly limited personnel resources present.

Methods

The objectives of this work were the optimization of the care of patients hospitalized in the Medical Area of the Azienda ospedaliero-universitaria Senese, the definition of priority and appropriateness criteria and the optimization and standardization of Physiotherapists’ workloads. To carry out the project, the logical path set on the phases defined by the Six Sigma’s acronym DMAIC was followed (DEFINE: Problem’s identification through the creation of a Project Charter that defines and plans the entire project; MEASURE: Measurement and collection of data, focusing attention on the type of patients, characteristics of the inpatient Departments, organization of the Rehabilitation Health Professions Unit and activities of the Physiotherapist staff at the Medical Area in question; ANALYZE: Interpretation of data and analysis of the root causes of the problem; IMPROVE: Generation and implementation of corrective actions; CONTROL: Monitoring and standardization of the optimized system).

Results

From the analysis of the measured data, critical issues emerged such as: 1) The time dedicated to the patient, considering direct and indirect activities, is lower than that defined by comparisons with other facilities, in the absence of shared standards, and compared to the needs and characteristics of the patients; 2) Some initial assessments carried out 4-5 days after the request due to the high volume of consultations activated; 3) A high percentage of assessments carried out in which treatment was not activated due to inconsistent requests; 4) Differences in the percentage of requests for evaluation on the total hospitalizations for pathology between the 2 Units of the Medical Area of the Azienda ospedaliero-universitaria Senese which denoted different rehabilitation culture.

Discussion and Conclusion

Starting from the analysis of the root causes, the countermeasures to be implemented were identified, the improvement actions were found and their implementation was designed and planned with the related times and responsibilities. The main ones were the creation of a culture on the importance of early physiotherapy management and patient handling, the setting up of a flow-chart for patient stratification and the definition of a shared communication tool on functional abilities. The expected advantages concerned both the users, since evaluating and treating the right patient in the right time and with the right modality provides a better quality of the intervention and better outcomes, and the organization, influencing hospitalization times and guaranteeing workloads for the Physiotherapists who allow you to work in quality and safety. Data collection is underway to verify the achievement of the set indicators.

REFERENCES

1 Chan L, et al. Disability and health care costs in the Medicare population. Arch Phys Med Rehabil 2002; 83:1196.

2 Vos T, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: A systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380:2163.

3 Murray CJ, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380:2197.

4 Gobbens RJ, et al. The predictive validity of the Tilburg Frailty Indicator: disability, health care utilization, and quality of life in a population at risk. Gerontologist 2012; 52:619.

5 Fried LP, et al. Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 2001; 56:M146-56.

6 Rockwood K, et al. Frailty in Relation to the Accumulation of Deficits. J Gerontol A Biol Sci Med Sci 2007; 62:722-7.

Effetti del trattamento robotico con dispositivo Hunova® sul controllo del tronco e sulle attività della vita quotidiana in pazienti acuti con lesione midollare: uno studio preliminare

Effects of robotic training with Hunova® on trunk control and ability to perform activities of daily living in acute spinal cord injury patients: a preliminary study

Autori

Serafino Francesca (Montecatone Rehabilitation Institute, Imola (BO), Italy)

Ricci Lucia (Montecatone Rehabilitation Institute, Imola (BO), Italy)

Sabatelli Simona (Montecatone Rehabilitation Institute, Imola (BO), Italy)

Materazzi Francesco Giuseppe (Montecatone Rehabilitation Institute, Imola (BO), Italy)

Baldarelli Fabio Alessandro (Montecatone Rehabilitation Institute, Imola (BO), Italy)

Menna Laura (Montecatone Rehabilitation Institute, Imola (BO), Italy)

Ciardulli Francesca (Montecatone Rehabilitation Institute, Imola (BO), Italy)

Cinotti Maria Giulia (Montecatone Rehabilitation Institute, Imola (BO), Italy)

Rucci Paola (Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy); Di Staso Rossana (Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy)

Baroncini Ilaria (Montecatone Rehabilitation Institute, Imola (BO), Italy); Simoncini Laura (Montecatone Rehabilitation Institute, Imola (BO), Italy)

Introduction

Patients with spinal cord injury (SCI) have impaired trunk and postural control (both static and dynamic), often with a major impact on activities of daily living (ADL) 1. Therefore, improving trunk mobility and strengthening trunk control are primary rehabilitation goals. Nowadays, robotic therapy can be added to conventional rehabilitation to improve trunk control, balance and proprioception in the seated position2.

The aim of this preliminary study is to evaluate the effects of intensive robotic therapy with the Hunova® device (Movendo Technology, Italy) on trunk control and ability to perform ADL in individuals with acute SCI. Specifically, we analysed the changes after robotic training with Hunova® on the following outcomes: Trunk Control Test for SCI (TCT-SCI), Self-care and Overall mobility subscales of the Spinal Cord Independence Measure-III (SCIM-III) and measurements from the Hunova evaluation tests.

Methods

21 SCI patients hospitalised at the Montecatone Rehabilitation Institute from March 2023 to May 2024 with acute (<6 months post-injury) motor complete (n=9) or incomplete (n=12) lesions (NLI level between C4 and L2) underwent robotic training for 1 hour a day, 5 days a week, for 2 weeks, in addition to conventional rehabilitation treatment. The robotic rehabilitation training included static and dynamic trunk control exercises and dual-task exercises. The following parameters were measured before (T0) and after (T1) robotic treatment and analysed retrospectively: TCT-SCI and SCIM-III for clinical assessment, centre of pressure (COP) related parameters and trunk range of motion (ROM) as recorded by Hunova®.

Analysis of variance for repeated measures (ANOVA) was performed to assess the overall change of parameters over time and differences in the trend of the scores according to the level of completeness. Statistical analyses were performed using JASP v.0.18.3 software with a significance level of p=0.05.

Results

The clinical scales scores TCT for SCI, SCIM III Self-care and SCIM III Overall mobility and the measurements recorded by Hunova® regarding the right and left ROM of the trunk improved significantly after the robotic rehabilitation sessions (p<0.05 from the ANOVA analysis at T0 and T1 of all considered outcomes).

Furthermore, when scores were analysed according to the level of completeness of the lesion, the TCT for SCI scale and the measurements of right and left ROM were significantly lower at T0 and T1 in the complete subjects than in the incomplete subjects (p<0.05 for TCT and ROM outcomes).

Discussion and Conclusion

The results of this study provide preliminary evidence of patients’ improvement in trunk control and mobility based on clinical evaluation scales and quantitative measurements recorded by the robotic device These improvements indicate that the robotic training has a beneficial effect in acute spinal cord injury patients.

REFERENCES

  1. Milosevic M, Masani K, Kuipers MJ, et al. Trunk control impairment is responsible for postural instability during quiet sitting in individuals with cervical spinal cord injury. Clin Biomech (Bristol, Avon). Jun 2015;30(5):507-12. doi: 10.1016/j.clinbiomech.2015.03.002
  2. Payedimarri AB, Ratti M, Rescinito R, Vanhaecht K, Panella M. Effectiveness of Platform-Based Robot-Assisted Rehabilitation for Musculoskeletal or Neurologic Injuries: A Systematic Review. Bioengineering (Basel). 2022 Mar 22;9(4):129. doi: 10.3390/bioengineering9040129.

Le prospettive dei genitori di bambini con paralisi cerebrale infantile (PCI) rispetto alla fisioterapia: analisi qualitativa del contesto italiano

Perspectives of parents of children with cerebral palsy (CP) regarding physiotherapy: a qualitative analysis of the Italian context

Autori

Paoli Silvia [Azienda Ospedaliera Universitaria – Meyer, Firenze, Italia]

Boso Elena [AULSS6 Euganea, Padova, Italia]

Savogin Chiara [AIAS Busto Arsizio, Busto Arsizio, Italia

Introduction

In the pediatric field, one of the biggest challenges for the physiotherapist is the relationship with the parents of a child with a disability, because every family, every parent, every person experiences the disability in their own way [1]. The relationship is also influenced by the parents’ beliefs about culture, health and disability which will influence the perspective and goal of the child’s education and rehabilitation[2,3]. In the Italian context there are no studies that have investigated the health expectations of Italian of children with CP and, more specifically, their perspectives on physiotherapy [4].

The study aims to explore the perspective of Italian parents of children between 2 and 6 years of age, diagnosed with CP, in relation to physiotherapy: the purpose of the therapy, how it is carried out, parental involvement and the interaction with other areas of the child’s life.

Methods

The study used qualitative methods, with semi-structured interviews conducted with parents of eligible children. The interview outline was extrapolated from an article in the primary care literature, modified and adapted to the Italian and physiotherapy context. The interview was tested on a small sample of parents to confirm its ability to obtain information on all topics. A physiotherapist, assisted by a communication expert, conducted the video interviews, which were recorded and then transcribed in full. The transcriptions were independently evaluated by two experimenters in order to identify the most common and recurring themes, through the identification of semantic labels. The two investigators met to compare and discuss the concordance of themes. Finally, the themes were organised according to the ICF framework as in other studies in the literature. The data from the final table were processed and then compared with the result in the literature.

Results

12 interviews were conducted with parents of eligible children from different Italian regions. Body functions and structures: parents are well informed about their children’s lack of competence. They want and are involved in their therapy, both during the therapy itself and at home, trying to repeat exercises and to correct movements.  Activity and participation: school is seen as a good place for children to interact and develop their relational skills and independence. Parents encourage children to do things on their own, respecting the need for more time, changing activities and the environment. Environmental factors: Parents are aware that they have a deep knowledge of their children and feel that they can express themselves for their benefit. Early and continuous treatment is seen by parents as an important factor and therapists become a constant reference. Information needs: Parents groups to share information, information about laws and psychological support when needed.

Discussion and Conclusion

The interviews conducted explored parents’ opinions on their children’s rehabilitation pathways in depth. Parents value early and continuous care, opportunities for discussion, and a respectful environment. They also want services to consider experimental approaches, driven by their desire to do everything possible for their child. However, physiotherapy interventions are uneven across Italy, and family-centered care principles are not yet standard practice nationwide. In the interviews, intervention strategies related to supporting participation seem to be less valued, parents describe participation less precisely than goals related to body functions and structures. Compared to international standards, the Italian experience is intermediate: there are significant opportunities for participation in school life, yet parents’ rehabilitation goals seem more focused on physical functions and structures.

REFERENCES

  1. Davidson A., Coliva M., Sarno C., Paoli S., 2017. Core competence del fisioterapista dell’area pediatrica: proposta per il contesto italiano. Scienza Riabilitativa. 2017, Vol. 19 Issue 2, p5-27. 23p
  1. Oudgenoeg-Paz, O., Atun-Einy, O., van Schaik, S.D.M., 2020. Two cultural models on infant motor development: Middle class parents in Israel and the Netherlands. Front. Psychol. 11.
  1. Jindal P., MacDermid J.C., Rosenbaum P., DiRezze B. & Narayan A., 2018. Perspectives on rehabilitation of children with cerebral palsy: exploring a cross-cultural view of parents from India and Canada using the international classification of functioning, disability and health, Disability and Rehabilitation, 40:23, 2745-2755
  2. Palomo-Carrión R., Romay-Barrero H., Pinero-Pinto E., Romero-Galisteo R., López-Muñoz P., Martínez-Galán I., 2021. Early Intervention in Unilateral Cerebral Palsy: Let’s Listen to the Families! What Are Their Desires and Perspectives? A Preliminary Family-Researcher Co-Design Study. Children.

Importanti discrepanze esistono tra protocollo registrato e manoscritto pubblicato negli studi randomizzati controllati che valutano l’esercizio nel mal di schiena cronico: uno studio di meta-ricerca

Substantial discrepancies exist between registered protocol and published manuscript in trials on exercise interventions for chronic low back pain: a meta-research study

Autori

Basso Giacomo [Department of Neurosciences, Rehabilitation, Ophthalmology, Genetic and Maternal Infantile Sciences (DINOGMI), University of Genova – Genova, Italy]

Bargeri Silvia [Unit of Clinical Epidemiology, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy]

Ignazio Geraci [Department of Neurosciences, Rehabilitation, Ophthalmology, Genetic and Maternal Infantile Sciences (DINOGMI), University of Genova – Genova, Italy]

Greta Castellini [Unit of Clinical Epidemiology, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy]

Alessandro Chiarotto [Department of Health Sciences, Faculty of Science, VU University Amsterdam, Amsterdam Movement Sciences, The Netherlands]

Silvia Gianola [Unit of Clinical Epidemiology, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy]

Raymond Ostelo [Department of Health Sciences, Faculty of Science, VU University Amsterdam, Amsterdam Movement Sciences, The Netherlands]

Marco Testa [Department of Neurosciences, Rehabilitation, Ophthalmology, Genetic and Maternal Infantile Sciences (DINOGMI), University of Genova – Genova, Italy]

Tiziano Innocenti [Department of Health Sciences, Faculty of Science, VU University Amsterdam, Amsterdam Movement Sciences, The Netherlands]

Introduction

Bias in the design, conduct or reporting of RCTs can result in inaccuracies in systematic reviews or guidelines and subsequent errors in clinical practice, overestimating or underestimating the effects of an intervention. A prominent issue is “reporting bias”, which may occur when there is a discrepancy between what was planned in the protocol and what is actually reported in the published manuscript of the RCTs.

Despite some improvement over time, the quality and reporting standards of trials in the exercise for chronic low back pain (CLBP), field is suboptimal. However, the extent of discrepancies between registered protocols and published manuscripts in CLBP trials remains uncertain.

Methods

This is a meta-research study, prospectively registered. We started from the 2021 ‘Exercise therapy for chronic low back pain’ Cochrane review to select all RCTs reporting a protocol registration on a primary register of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) or in ClinicalTrials.gov. Standardized data collection forms were developed to record information from both registered protocol and published manuscript. Independent pairs of reviewers assessed discrepancies between registered protocol and published manuscript for the reporting of primary and secondary outcomes domains, measurement instruments, time-points, number of arms and statistical analysis plans (if attached). Outcome discrepancies were characterized as addition, omission, upgrade or downgrade. We used descriptive statistics to assess the proportion of RCTs with and without a discrepancy.

Results

We included 116 RCTs reporting an available protocol registration. Overall, 100 RCTs (86.2%) distinguished between primary and secondary outcomes. Of these, 39 RCTs (39.0%) reported one or more discrepancies in primary outcomes, and 78 RCTs (78.0%) reported one or more discrepancies in secondary outcomes. Focusing on discrepancies for the primary outcome, 64.5% of added, upgraded or downgraded outcomes favored statistically significant effects. Few RCTs (n=6) reported discrepancies in the number of arms. Statistical analysis plans were poorly reported in the registered protocols (n=3) for being compared to the publications.

Discussion and Conclusion

We found substantial outcome discrepancies comparing registered protocols and published manuscripts in RCTs assessing exercise interventions for patients with cLBP, with some impacting the statistical significance of the effects. Readers are encouraged to approach RCTs results in this field with caution.

REFERENCES

Hart B, Lundh A, Bero L. Effect of reporting bias on meta-analyses of drug trials: reanalysis of meta-analyses. BMJ. 2012;344:d7202.

Page MJ, Higgins JPT, Sterne JAC. Chapter 13: Assessing risk of bias due to missing results in a synthesis. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane, 2023. Available from www.training.cochrane.org/handbook.

Boutron I, Page MJ, Higgins JPT, Altman DG, Lundh A, Hróbjartsson A. Chapter 7: Considering bias and conflicts of interest among the included studies. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane, 2023. Available from www.training.cochrane.org/handbook.

Hayden JA, Ellis J, Ogilvie R, Boulos L, Stanojevic S. Meta-epidemiological study of publication integrity, and quality of conduct and reporting of randomized trials included in a systematic review of low back pain. J Clin Epidemiol. 2021;134:65-78.

Teleriabilitazione tra innovazione ed efficacia: Progetto Pilota nell’ASL Roma 1

Tele-rehabilitation between innovation and effectiveness: the pilot project in ASL Rome 1

Autori

Mascaro Ivana (ASL Roma 1, Roma, Italia)

Gemma Antonella (ASL Roma 1, Roma, Italia)

Guicciardi Mauro (ASL Roma 1, Roma, Italia)

Introduction

Following the Covid-19 pandemic, ASL Roma 1 implemented response strategies to ensure the continuity of rehabilitative treatments, utilizing advanced technologies provided by Khymeia Group S.R.L. purchased with European funds from POR FESR LAZIO 2014-2020. This furniture plays an indispensable role in cases where the presence of an operator at the patient’s home was not possible. Starting in 2022, a pilot project for telerehabilitation was initiated within the home care services of District XIII in Rome. This project involved a multidisciplinary team consisting of geriatricians, physiatrists, and physiotherapists, alongside patients suffering from femur fractures. These sessions were conducted using technological apparatus provided to the patient, aimed at monitoring the correct execution of exercises remotely through motion sensors.

Methods

Between March 2022 and September 2023, 61 patients residing in District XIII, aged between 42 and 91 years and of both genders, underwent telerehabilitation. Patient intake and training for telerehabilitation were conducted at the patient’s residence. For each patient, data were collected from 12 online work sessions held twice a week, supplemented by 18 in-person sessions conducted three times a week. The physiotherapist utilized scales of functionality and autonomy to monitor patient’s  progress, including: Barthel Index; Gait Index; Modified Harris Hip Score. These scales were administered by the physiotherapist at the beginning and end of the treatment to compare outcomes between time 0 and time 1.

Results

Despite the limited number of subjects involved in the sample, all patients showed significant improvement in their health status by enhancing functional capabilities and autonomy. This was attributed to the intensive approach adopted, which allowed the implementation of multiple methods, thus accelerating the recovery and healing process. Nevertheless, the service is not yet usable for patients with severe cognitive deficits and significant motor impairments, but future development in this regard is hoped for.

Discussion and Conclusion

It confirms itself to be an additional approach to rehabilitation, not in competition with in-person treatments, but rather in support of and integration with them. It enables a remote relationship between healthcare providers and patients, alleviating challenges related to travel and distance. Moreover, it promotes treatment continuity, leveraging the increasing technological literacy process, alongside patients’ awareness of actively participating in their own recovery process. 

REFERENCES

Tsuge T, Yamamoto N, Taito S, Miura T, Shiratsuchi D, Yorifuji T. Efficacy of telerehabilitation for patients after hip fracture surgery: A systematic review and meta-analysis.  J Telemed Telecare. 2023 Jul;

Agostini M, Moja L, Banzi R, Pistotti V, Tonin P, Venneri A, Turolla A. Telerehabilitation and recovery of motor function: a systematic review and meta-analysis. J Telemed Telecare. 2015 Jun;21(4):202-13;

Sherrington, C., & Tiedemann, A. (2015). Physiotherapy in the prevention of falls in older people. Journal of physiotherapy, 61(2), 54-60.

Instabilità posturale nei pazienti con neuropatia ereditaria: studio del ruolo del sistema somatosensoriale e motorio

Postural instability in hereditary neuropathy patients: studying the role of somatosensory and motor involvement

Autori

Gardoni Andrea [Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy; and Vita-Salute San Raffaele University, Milan, Italy]

Sarasso Elisabetta [Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy; and Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Health, University of Genoa, Genoa, Italy]

Sorrenti Benedetta [Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; and Vita-Salute San Raffaele University, Milan, Italy]

Pietroni Luca [Vita-Salute San Raffaele University, Milan, Italy]

Bosco Luca [Neurology Unit and Neurophysiology Service, IRCCS San Raffaele Scientific Institute, Milan, Italy]

Strano Camilla Mirella Maria [Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; and Vita-Salute San Raffaele University, Milan, Italy]

Zenere Lucia [Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy]

Falzone Yuri Matteo [Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy]

Agosta Federica [Neuroimaging Research Unit, Division of Neuroscience, and Neurology Unit IRCCS San Raffaele Scientific Institute, Milan, Italy; and Vita-Salute San Raffaele University, Milan, Italy]

Previtali Stefano Carlo [Neurology Unit and Institute of Experimental Neurology and Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy] Filippi Massimo [Neuroimaging Research Unit, Division of Neuroscience; Neurology Unit; Neurorehabilitation Unit; and Neurophysiology Service, IRCCS San Raffaele Scientific Institute, Milan, Italy; and Vita-Salute San Raffaele University, Milan, Italy]

Introduction

People with peripheral neuropathy present an increased risk of falls due to an impaired balance control resulting from muscular weakness and/or reduced sensation. This study aimed at investigating the impact of muscular weakness and somatosensory deficits on steady-state and dynamic balance in people with peripheral neuropathy.

Methods

Twenty patients with Charcot-Marie-Tooth (CMT), 17 patients with predominantly motor disorders (MOT) (hereditary motor neuropathy or distal myopathy), 9 patients with sensory neuropathy (SENS) and 10 healthy controls were included. Subjects underwent: lower limb muscle strength tests; tactile sensitivity and pallesthesia assessments; evaluation of tactile-pressure sensory threshold of plantar surface of the foot with Semmes-Weinstein monofilaments; measure of passive range of motion of the ankle; static and dynamic balance tests with the Balance Evaluation Systems Test (BESTest). Specific items from the BESTest were performed on a force platform to observe center of pressure (COP) displacement during the exploration of stability limits, the anticipatory postural adjustments (APA) and the maintenance of orthostatism under sensory deprivation conditions.

Results

Assessments confirmed the presence of sensory deficit in CMT and SENS patients. CMT and MOT groups were weaker than the controls; SENS had no significant differences with healthy subjects on lower limb strength. CMT, MOT and SENS patients showed significant impairment in steady-state and dynamic balance compared with controls. No statistically significant difference was observed between CMT, SENS and MOT patients in reactive balance. SENS performed better than CMT patients in proactive balance. Stability limits were similar among the different groups, while the amplitude of APA was on average greater in patients than in controls. In static balance, patients with sensory deficits had greater COP oscillations than MOT and controls. On the other hand, the latter groups performed similarly in static oscillations. In the CMT group, increased time at the Timed-Up-and-Go test and reduced BESTest score correlated with sensory deficit, dorsal and plantar flexor weakness, and disease severity.

Discussion and Conclusion

Somatosensory deficit and muscular weakness play different roles in postural instability in individuals with peripheral neuropathies. Isolated distal muscle recruitment deficits do not seem to affect steady-state balance, whereas sensory deficits play a pivotal role on instability in static conditions. Both strength and sensory deficits impact on the ability to maintain balance on unstable surface and on dynamic balance, with the latter being mostly dependent on the integrity of the motor system. These findings provide new insights into the systems responsible for postural instability in patients with peripheral neuropathies and justify further research on the efficacy of rehabilitative treatments focused on improving balance in patients with distal deficits, whether they are motor or sensory.

REFERENCES

Interazione Paziente-Terapista nella riabilitazione robotica per soggetti affetti da lesione del midollo spinale

Patient-therapist interaction during robotic gait rehabilitation in individuals with spinal cord injury.

Autori

Tamburella Federica, Department of Life Sciences, Health and Health Professions, Link Campus University of Rome, Italye

Floriana Pichiorri, Neuroelectrical Imaging and BCI Laboratory, IRCCS Fondazione S. Lucia, Rome, Italy

Andrea Ranieri, Neuroelectrical Imaging and BCI Laboratory, IRCCS Fondazione S. Lucia, Rome and Department of Computer, Control and Management Engineering, Sapienza University of Rome, Italy

Francesca Patarini, Neuroelectrical Imaging and BCI Laboratory, IRCCS Fondazione S. Lucia, Rome, Italy

Giada Serratore, Spinal Center and Spinal Rehabilitation Laboratory, IRCCS Fondazione S. Lucia, Rome; Italy

Alessandra Bigioni, Spinal Center and Spinal Rehabilitation Laboratory, IRCCS Fondazione S. Lucia, Rome; Italy

Donatella Mattia, Neuroelectrical Imaging and BCI Laboratory, IRCCS Fondazione S. Lucia, Rome, Italy

Giorgio Scivoletto, Spinal Center and Spinal Rehabilitation Laboratory, IRCCS Fondazione S. Lucia, Rome, Italy

Giordano Guredda, Spinal Center and Spinal Rehabilitation Laboratory, IRCCS Fondazione S. Lucia, Rome, Italy

Jlenia Toppi, Neuroelectrical Imaging and BCI Laboratory, IRCCS Fondazione S. Lucia, Rome and Department of Computer, Control and Management Engineering, Sapienza University of Rome, Italy

Introduction

Patient’s active participation in the rehabilitation process is crucial for optimizing outcomes (Knutti K. et al., 2022). Patient’s adherence to rehabilitation plan has traditionally been mediated by the interaction with the therapist (empathy, motivation, reward) and thus by the relationship established between them along the rehabilitation pathway (Tamburella F. et al, 2017). The growing interest in robotic rehabilitation sets up to a deeper study of the role of the therapist and its robot-mediated interaction with the patient. The aim of this study was to address the therapist-patient interaction during robotic gait rehabilitation in individuals with spinal cord injury (SCI) in terms of selective attention and electroencephalography (EEG) activity.

Methods

Ten individuals with sensory-motor incomplete SCI were enrolled. The patients underwent neurological and gait-specific functional assessments at the enrollment and after the training. Training was based on 8 sessions with the Lokomat exoskeleton, the first of which consisted of a familiarization with the device for the setting of parameters to be held constant during the other sessions. In the following six sessions, 3 types of feedback (FB) (chart, smile, game FBs; 2 sessions per FB) from those available from the manufacturer were randomly administered, with patients wearing an eye-tracking system to assess their selective attention towards tree different areas: the FB Lokomat screen, the therapist, their surroundings. These sessions were timed by instructing the therapists to 3 different levels of interaction with the patient: 1) maximal interaction: explanation of the FB and its operation in a near-continuous manner; 2) medium interaction: assignment of specific tasks to the patient while limiting communication related to other aspects; 3) minimal interaction: patient free to interact with the Lokomat without therapist intervention. The last session consisted of a co-registration of eye-tracking and high-density EEG during minimum and maximum interaction levels with the 3 different FBs.

Results

The most visited area of interest was the FB screen, regardless of the experimental condition. The therapist area was visited the most in the maximum interaction case. In the game FB, the therapist area was less visited, and this was also the mode by which less distraction (surrounding environment) was observed. In the condition of minimum interaction for the 3 types of FBs the motor areas of the lower limbs turned out to be essentially active, as the subject was focused on ambulatory training. Activations in the medial prefrontal cortex during the maximal interaction with the therapist while administering the chart FB were evidenced. The chart FB was considered the most complicated from the point of view of comprehension. A general improvement of gait performance was also reported.

Discussion and Conclusion

Results indicate that during robotic gait rehabilitation the interaction between therapist and patient was influenced by both type of FB used and level of interaction. In particular, patient tends to fully immerse himself in the task during the game FB by minimizing the gaze direction towards the therapist. Finally, the FB chart administration maximally activates the medial prefrontal cortex, which is a key region in social interaction mechanisms.

REFERENCES

Knutti K, Björklund Carlstedt A, Clasen R, Green D. Impacts of goal setting on engagement and rehabilitation outcomes following acquired brain injury: a systematic review of reviews. Disabil Rehabil. 2022 Jun;44(12):2581-2590. doi: 10.1080/09638288.2020.1846796. Epub 2020 Nov 19. PMID: 33211986.

Tamburella F, Moreno JC, Iosa M, Pisotta I, Cincotti F, Mattia D, Pons JL, Molinari M. Boosting the traditional physiotherapist approach for stroke spasticity using a sensorized ankle foot orthosis: a pilot study. Top Stroke Rehabil. 2017 Sep;24(6):447-456. doi: 10.1080/10749357.2017.1318340. Epub 2017 May 1. PMID: 28460597.

Lo Statuto Epistemologico legame tra due complessità – scienza e morale

The Epistmiological Statute, a link between two complexities: science and moral

Autori

Filippo Cavallaro (Università degli studi di Messina)

Rosario Fiolo (Università degli studi di Palermo)

Mariachiara Ceccio (Università degli studi di Messina)

Teresa Pintaudi (Università degli studi di Messina)

Francesco Bonanno (Università degli studi di Messina)

Introduction

In 2013, “The Epistemological Statute of Physiotherapy” was drafted in Messina and then was published in Aifi’s official journal “Fisioterapisti” 55/2014. It was the synthesis gained in months, studying the founding documents of the profession.

The Professional Profile, Code of Ethics, Core Competence and Core Curriculum represent the foundation on which the Epistemological Statute is built. This foundation charter would have described the physiotherapy discipline allowing its growth and development.

There was an awareness that physiotherapy, like medicine, dealing with living and unique beings, needed a practice of tailored therapeutic interventions, activities and treatments in the management of the person’s functional recovery.

The Epistemological Statute was proposed as a link between the complexity of science and the heterogeneity of morality

Methods

The congress theme led us to take a fresh look at the documents produced since the promulgation of the Professional Profile DM 741, 14.9.1994.

These are: Code of ethics, Core competencies and Core curriculum.

The references that helped us to look with a different point of view were the rereading of the works of Maturana and Varela and the enlightening contribution of Edgar Morin.

Results

Maturana and Varela state that “all living beings are equal as long as they are alive” because by the fact that they are all living, in them are fulfilled all the necessary conditions for an uninterrupted ontogeny of the individual. They also declare that with the study and the development of knowledge we have moved from the “innocence of knowledge” to the “knowledge of the knowledge”. In fact the knowledge of knowledge obliges us to keep an attitude of permanent vigilance against the temptation of certainty. The relationship that we create with others, with the patient, is an act of coexistence, and for this reason it is human. “This bond between human beings is the foundation of all ethics as a reflection on the legitimacy of the other’s presence”.

Morin teaches us that “The sciences … have not only a proper complexity to human realities, but also a particular issue, because the researchers of these disciplines are human beings, who works on, with and for other human beings.” He directs us toward a reasoning that can grasp the multidimensionality of realities, recognizing the interactive and retroactive interplay, dealing with complexities, rather than giving up to the ideological oppositions or to the mutilations dictated by exaggerated specialization (the new pathology of knowledge). For Morin, “Human needs are not only economic or technical, but also affective and mythological.”

However, this does not detract that medical treatments that do not take into consideration the wholeness of the organism and its complexity. Often these dimensions have undesirable side effects. Health and disease should both be considered as subjective experiences, Morin says, emerging from the specific bio-psycho-social-environmental evolutionary interweaving that characterizes each individual uniquely and unrepeatably. For this reason personalized intervention procedures are required, and nowadays the lack of these tailor-made protocols is severely complained

Discussion and Conclusion

Only with a link between the complexity and the ongoing relationship between scientific education and moral growth we will have a new epistemological status

REFERENCES