EFFECTIVENESS OF EXERCISE IN THE CONSERVATIVE TREATMENT OF PERIPHERAL OBLITERANT ARTERIOPATHY: A SYSTEMATIC REVIEW

Introduction

The Peripheral Artery Disease (PAD) is a vascular pathology characterized by a stenosis or a narrowing of the arteries of the lower limb, caused by the atherosclerotic disease with which shares the major risk factor. The primary symptom is claudicatio intermittens (CI), described as cramping pain primarily in the calves, relieved by rest within 10 minutes (1;2). The PAD treatment involves the control of the symptomatology and the interruption of the progression of the atherosclerosis, through prevention and rehabilitation protocols (3). Several studies have demonstrated the fundamental importance of conservative treatment based on supervised exercise training (SET), due to the increased tissue perfusion and angiogenesis it induces, improving circulation to the lower extremities (4). The objective of the study is to evaluate which form of exercise is more specific and effective for the conservative treatment of PAD

Methods

The literature search, conducted following the international PRISMA guidelines using the PICO strategy (Figure 1), was carried out through the Medline (via PubMed), Scopus and PEDro databases between December 2022 and January 2023. Common search strings have been formulated for Medline and Scopus. The string Peripheral artery disease was also used on PEDro (Figure 2). Furthermore, the search for the articles was limited using the following filters: year of publication (between 2012 and January 15, 2023), language (English), type of study (RCT). Relevant articles were selected by title, duplicates were eliminated using EndNote software. The articles were then chosen based on the reading of the abstract and ultimately the full text (Figure 3). After inclusion, the methodological quality of the selected RCTs was assessed using the PEDro scale (Figure 4).

Results

After the search conducted on the multimedia databases, the studies considered useful and relevant and therefore included in this systematic review were 7, composed only of randomized controlled trials (RCTs). Most of the studies included in the revision have predicted, for the intervention group (WTG), intermittent walking exercises on the treadmill, while the training intensity varied in the different protocols. Some of the studies included, not all have a control group. The studies analysed present, as the most shared outcomes, those relating to 2 macro-areas: cardiovascular function and functional capacity (exercise), which were evaluated in almost all of the studies through the use of heterogeneous scales and instruments. When assessing functional capacity, improvements were noted in nearly all groups undergoing a complete rehabilitation program. In the evaluation of cardiovascular function, however, heterogeneous results were obtained

Discussion and Conclusion

According to the AHA/ACC (3) guidelines 2016 on the management of patients with PAD, walking is the first-line therapy. What unites the rehabilitation protocols analyzed is the use of aerobic exercise, based on walking/treadmills and muscle relaxation techniques, to obtain progressive functional improvements and a reduction in the level of disability of the patients. Despite heterogeneous rehabilitation protocols for PAD in the literature, in terms of intensity, timing and duration of exercise, cardiovascular rehabilitation based on the combination of aerobic training at regular or continuous intervals and at high or low intensity, has proved to be able to improve patients’ health, well-being and quality of life (QoL) and enhance the exercise capacity and strength of the walking muscles.

REFERENCES

1. Wennberg PW. Approach to the pa­tient with peripheral arterial disease. Cir­culation 2013; https://doi.org/10.1161/CIRCULATIONAHA.
2. Gerhard-Herman MD, et al. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.
3. Aboyans V, et. al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases. European Heart Journal. 2018 Mar
4. Aboyans V., et al. Measurement and interpretation of the ankle-brachial index: A scientific statement from the American Heart Association. Circulation. 2012

Are there sex and gender differences in low back pain interventions of randomized controlled trials? A meta-research study

Introduction

Low back pain (LBP) is the leading cause of Years Lived with Disability worldwide. The global prevalence of LBP is higher among females compared with males across all age groups (1). To improve LBP management, various rehabilitation interventions recommended by high quality clinical practice guidelines are effective (2). However, treatment effects can be different in male and female. This can also depend on the recruitments of participants in the randomized controlled trials (RCTs). Thus, we investigated the prevalence of different sex and gender participants in LBP trials to improve knowledge in sex and gender differences, enhancing tailored healthcare and external validity of randomized controlled trials.

Methods

Results

Discussion and Conclusion

REFERENCES

Mapping Patient-Reported Outcome Measures Used to Identify the Unmet Needs of Cancer Survivors onto the International Classification of Functioning, Disability and Health (ICF)

Introduction

As the number of cancer survivors (CSs) is increasing worldwide, providing services relevant to their specific, unmet needs is essential. There are currently various patient-reported outcome measures (PROMs) whose aim is to identify the unmet needs of CSs. Still, limited guidance supports healthcare providers in choosing the most appropriate PROMs for this purpose.

An International Classification of Functioning, Disability, and Health (ICF)–based analysis of existing PROMs may facilitate reliable identification of the areas of impact on health encompassed by them, providing a basis for the selection of a specific PROM based on content comparison.

The objective of this study was to assess the content and evaluation constructs of the PROMs used to identify the unmet needs of adult CSs suffering from non-cutaneous cancers with a 5-year survival of ≥ 65% and an incidence of ≥ 5%.

Methods

A mapping exercise was performed to evaluate the degree to which the PROMs used to identify the unmet needs of adult CSs covered the spectrum of health-related states, outcomes and determinants described by the WHO ICF.

The materials for the analysis were 14 PROMs whose aim is to identify the unmet needs of our population of interest.

Each item of all the PROMs was extracted and linked, word by word, to the ICF by two independent reviewers using the Cieza et al. updated procedure of linking rules. Where disagreements occurred, these were resolved through discussion and consultation with a third reviewer. The ICF was used to determine to which chapter of its hierarchical structure each item of the analysed PROMs could be categorized to represent body structures, body functions, activity and participation, or environmental factors.

The ICF-linked PROMs were then further screened to obtain an overall framework on how comprehensively they covered ICF categories.

Results

The study is ongoing. Mapping has been completed, and the data analysis is under way.

We expect to have the principal results ready to be presented at the AIFI International Scientific Congress “Tailored Physiotherapy. Una strategia per il futuro” in November 2023.

Preliminary results show that, despite a wide range of variability, each of the 14 PROMs covered the ICF components of body functions, activity and participation, and environmental factors in different proportions, thus revealing their own specificity in capturing different nuances of apparently similar problems.

Discussion and Conclusion

The ICF, created by the World Health Organization, provides an internationally recognized framework, definitions and coding language to describe the impact of health conditions on body functioning, activities limitation and restrictions in participation.

The linking rules enhance the comparability of PROMs by providing a comprehensive overview of the content of the same, the context in which the measurements take place, the perspectives adopted and the types of response options.

Linking the PROM domains to ICF components enables the adoption of a universal language. This facilitates reliable identification of the areas of impact on health encompassed by these PROMs, revealing their own specificity in capturing different nuances of apparently similar problems and providing a basis for the selection of the most suitable based on content comparison in clinical practice and research.

REFERENCES

World Health Organization. Towards a common language for functioning, disability, and health: ICF. The international classification of functioning, disability and health. 2002.

Cieza A, Geyh S, Chatterji S, Kostanjsek N, Ustün B, Stucki G. ICF linking rules: an update based on lessons learned. J Rehabil Med. 2005;37:212-8.

Cieza A, Fayed N, Bickenbach J, Prodinger B. Refinements of the ICF Linking Rules to strengthen their potential for establishing comparability of health information. Disabil Rehabil. 2019;41:574-83.

Cieza A, Brockow T, Ewert T, Amman E, Kollerits B, Chatterji S, et al. Linking health-status measurements to the international classification of functioning, disability and health. J Rehabil Med. 2002;34:205-10.

World Health O. International classification of functioning, disability and health : ICF. Geneva: World Health Organization; 2001.

The Berg Balance Scale is a proper tool to measure balance in persons with Multiple Sclerosis and an advanced walking disability: evidence from Rasch analysis

Introduction

Persons with Multiple Sclerosis (PwMS) are at high risk of falling, and falls are proven to be consistently associated with balance impairment.

The Berg Balance Scale (BBS) is one of the most widely used tools to assess balance in PwMS, also within RCTs. Reliability and validity of the BBS in PwMS were evaluated through the Classical Theory Test (concurrent validity with Dynamic Gait Index (r=0.780) and the Timed-Up-and-Go test (r=0.620). It discriminated with a low sensitivity between fallers and non-fallers. Inter-rater and intra-rater reliability were excellent (ICC=0.960).

Unfortunately, these traditional psychometric procedures cannot assess some crucial requirements underlying the use of rating scales such as the BBS. Indeed, Rasch analysis has emerged as a powerful tool to evaluate the measurement quality of a scale.

Hence, this study aims to evaluate the BBS measurement properties in a multicenter sample of PwMS through Rasch analysis.

Methods

Data were collected retrospectively within the outpatient Neuro-rehabilitation services of three Italian centers for 814 PwMS, adhering to these inclusion criteria: clinically or laboratory-definite multiples sclerosis; ability to stand independently for more than 3 seconds. For each participant, we collected the BBS, the Expanded Disability Status Scale (EDSS), the Activity-specific Balance Confidence (ABC) scale, and the number of falls (previous two months).

Using the Confirmatory Factor Analysis and Mokken Analysis, a preliminary unidimensional analysis of the BBS total sample (1220 observations) was performed. The sample was splitted into one validating (B1) and three confirmatory subsamples (Figure 1). Following the Rasch analysis performed on B1, item estimates were exported from B1 and anchored to the other subsamples.

Then, we studied the convergent and discriminant validity of the scale (BBS-MS) with the three external indicators.

Results

CFA and MA showed sufficient preliminary unidimensionality. The Rasch analysis on B1 failed monotonicity, local independence, and unidimensionality, and did not fit the Rasch model. After grouping locally dependent items, the BBS-MS fitted the model (χ²_df=23.8₈; p=.003) and satisfied all requirements for adequate internal construct validity (ICV) (Table 1). However, it was mistargeted to the sample (targeting index=1.922), with a distribution-independent Person Separation Index equal to 0.962, sufficient for individual measurements (Figure 2). The B1 final solution was replicated on A1, A2, and B2 subsamples, and the B1 item estimates were anchored to the confirmatory subsamples, satisfying the fit to the model (χ²=[19.0, 22.8], p-value=[.015, .004]) and all ICV requirements (Table 2).
BBS-MS directly correlated with the ABC scale (rho=.523) and inversely with EDSS (rho=-.573). It significantly differed across groups based on the EDSS, the ABC scale, and the number of falls.

Discussion and Conclusion

To our knowledge, this is the first study reporting on the Rasch analysis of the BBS for PwMS. It supports the ICV, reliability, and targeting of the BBS-MS as a measurement tool in an Italian multicentre sample of PwMS. Using one validation and three confirmation subsamples, we demonstrated the BBS-MS fitting to the Rasch model and the satisfaction of all requirements for adequate ICV.

On the other hand, the scale was slightly mistargeted to our convenience sample as its items were, on average, less difficult than the mean ability of the sample, uncovering significant targeting issues for a precise balance measurement in still ambulatory PwMS.

Indeed, our study suggested that the BBS-MS may be a precise and responsive measurement scale to assess balance in RCTs targeted to more disabled PwMS with an advanced walking disability. Thanks to this validation, we provided interval-level measures of balance ability, allowing parametric statistics to be used.

REFERENCES

1. Nilsagard, C. Lundholm, E. Denison, and L.G. Gunnarsson, Predicting accidental falls in people with multiple sclerosis — a longitudinal study. Clin Rehabil 23 (2009) 259-69
2. V. Jacobs, and S.L. Kasser, Balance impairment in people with multiple sclerosis: preliminary evidence for the Balance Evaluation Systems Test. Gait & posture 36 (2012) 414-8.
3. Cattaneo, J. Jonsdottir, and S. Repetti, Reliability of four scales on balance disorders in persons with multiple sclerosis. Disability and rehabilitation 29 (2007) 1920-5.
4. Hobart J, Cano S. Improving the evaluation of therapeutic interventions in multiple sclerosis: the role of new psychometric methods. Health Technol Assess 13 (2009) (12): iii, ix-x, 1-177.
5. Tennant, and P.G. Conaghan, The Rasch measurement model in rheumatology: what is it and why use it? When should it be applied, and what should one look for in a Rasch paper? Arthritis Rheum 57 (2007) 1358-62.

Immediate effects of trunk rotator stretching exercise on gait parameters in subjects with Parkinson’s disease: a randomized clinical trial

Introduction

Reduced trunk rotation and pelvic mobility, which are associated with a higher risk of falling and one of the best predictors of gait improvement following rehabilitation [ 1 ], are characteristics of subjects with Parkinson’s disease (swPD) [ 2 ]. The Progressive Modular Rebalancing System (PMR) proved to be an effective multimodal exercise therapy strategy with a trunk mobility focus that can enhance the effects of cognitive strategies in swPD gait training [ 3 ]. The purpose of this study was to compare the immediate effects of PMR trunk rotator stretching exercise to active upper trunk rotation exercise (Control) on gait parameters in swPD.

Methods

An expert neurologist screened 40 swPD for inclusion before randomly assigning them to the PMR or control exercise groups using sealed envelopes. Gait trials were collected using a magneto-inertial measurement unit placed at the lower back before (T0) and immediately after (T1) a single exercise session. Spatio-temporal parameters, pelvic kinematics, and harmonic ratios (HR) in three spatial directions were calculated. Four physical therapists who were not aware of the gait assessment carried out the PMR or control exercise. The entire procedure took between 10 and 15 minutes. To assess differences between groups, the independent sample t-test or Mann-Whitney test was used. Within-group differences were assessed using the paired sample t-test or the Wilcoxon test.

Results

At T1, there were significant differences in pelvic obliquity and HR in the antero-posterior (AP) direction between the PMR and control groups (Fig. 1). The PMR group improved in pelvic obliquity, pelvic rotation, HR in the AP and medio-lateral directions, gait speed and cadence, and double support time. Pelvic obliquity and cadence improved in the control group (Fig. 1).

Discussion and Conclusion

PMR trunk rotation stretching was more effective than upper trunk rotation exercise in improving pelvic mobility and harmonic ratio during gait in swPD patients in a single exercise session. Implementing a PMR trunk rotation stretching exercise into a gait rehabilitation program may enhance the effects of gait training by improving pelvic mobility and trunk behavior during gait.

REFERENCES

Serrao, Mariano et al. “Progressive Modular Rebalancing System and Visual Cueing for Gait Rehabilitation in Parkinson’s Disease: A Pilot, Randomized, Controlled Trial With Crossover.” Frontiers in neurology vol. 10 902. 29 Aug. 2019, doi:10.3389/fneur.2019.00902

Trabassi, Dante et al. “Machine Learning Approach to Support the Detection of Parkinson’s Disease in IMU-Based Gait Analysis.” Sensors (Basel, Switzerland) vol. 22,10 3700. 12 May. 2022, doi:10.3390/s22103700

Serrao, Mariano et al. “Prediction of Responsiveness of Gait Variables to Rehabilitation Training in Parkinson’s Disease.” Frontiers in neurology vol. 10 826. 2 Aug. 2019, doi:10.3389/fneur.2019.00826

Castiglia, Stefano Filippo et al. “Harmonic ratio is the most responsive trunk-acceleration derived gait index to rehabilitation in people with Parkinson’s disease at moderate disease stages.” Gait & posture vol. 97 (2022): 152-158. doi:10.1016/j.gaitpost.2022.07.235

The Early Functional Abilities-revised may bridge the measurement gap between the disorder of consciousness and the functional independence scales: a Rasch analysis study

Introduction

A measurement gap between the disorder of consciousness (DoC) and functional independence scales is present, as both cannot measure the recovery of early functional changes occurring on emergence from DoC. The Early Functional Abilities scale (EFA) was developed to bridge this gap. It describes clinically observable changes concerning purposeful activities, illness and disability awareness, and the ability to comply with medical, nursing, and therapeutic interventions.

In 2018, Poulsen et al. assessed the internal construct validity (ICV), reliability, and measurement precision of EFA in patients with TBI with Rasch analysis. The analysis rejected unidimensionality and did not recommend summarizing the four subscale measures into an EFA total score.

This study investigated whether selecting a valid content subset of items (EFA-R) from the original EFA was possible, providing an essentially unidimensional measurement of early functional ability.

Methods

In a multicenter observational cross-sectional study, we included three hundred sixty-two adults diagnosed with DoC due to a severe acquired brain injury (sABI) on admission to eleven Italian rehabilitation centers. We excluded patients with pre-existing neurological degenerative pathologies and/or concurrent illnesses likely to compromise survival within six months. Each patient was represented with only one chosen random evaluation in the dataset to avoid the risk of time dependency.

The Italian version of EFA (20 items with a five-point score grouped in 4 subscales) was administered to the sample and then submitted to Mokken analysis (MA), Confirmatory Factor Analysis (CFA), Rasch analysis, Confirmatory Bifactor Analysis (CBA), and external construct validity.

When available, we also collected the Coma Recovery Scale-Revised (CRS-R) and the FIM^TM for each person at the same time point for sample description and external validity purposes.

Results

According to MA and CFA, the Italian EFA showed sufficient preliminary unidimensionality. Within Rasch Analysis, a final 12-item solution (EFA-R) was calibrated. EFA-R is “essentially unidimensional” according to 1) analysis of residual correlations supporting item essential local independence; 2) a robust correlation between item subtests (rho=0.950); 3) only 2.1% of cases with significant difference between person parameter estimates by different subscales; 4) an explained common variance equal to 0.916 obtained from a final CBA. The invariance requirement (unconditional χ²_df=9.81₂₀; p=0.457, conditional class-interval based χ²_df=33.1₃₅; P=0.557) and monotonicity were also satisfied (Table 1). The reliability (Person Separation Index=0.887) was adequate for person measurements (Figure 1). A practical raw-score-to-measure conversion table based on the EFA-R calibration was devised (Table 2). Finally, EFA-R strongly correlated with CRS-R (rho=0.922) and motor FIM™ (rho=0.808).

Discussion and Conclusion

EFA-R is an essentially unidimensional subset of 12 items with adequate ICV and sufficient reliability for individual measurement under the Rasch Model Theory framework in patients with sABI. It has the potential to measure people’s functional abilities whose consciousness is improving despite ongoing severe motor-functional impairments during the early stages of rehabilitation. It covers all four original conceptual domains. The item hierarchy was consistent with the theoretical and expected order of functional recovery in these patients. The raw-score-to-measure conversion table provides interval-level estimates of early functional abilities, essential for correctly interpreting change scores and using parametric statistics.

Given the strong correlation with CRS-R and mFIM^TM, it provides “a measurement bridge” between the DoC and the functional independence scales in patients with sABI, overcoming the ceiling and floor effects of the two scales (Figure 2).

REFERENCES

1. Heck G, Steiger-Bächler G, Schmidt T. Early Functional Abilities (EFA) – eine Skala zur Evaluation von Behandlungsverläufen in der neurologischen Frührehabilitation. Neurol Rehabil 2000;6:125–33.
2. Poulsen I, Kreiner S, Engberg AW. Validation of the Early Functional Abilities scale: an assessment of four dimensions in early recovery after traumatic brain injury. J Rehabil Med 2018;50:165–72.
3. Tennant A, Conaghan PG. The Rasch measurement model in rheumatology: what is it and why use it? When should it be applied, and what should one look for in a Rasch paper? Arthritis Rheum 2007;57:1358–62.
4. La Porta F, Caselli S, Ianes AB, Cameli O, Lino M, Piperno R, et al. Can we scientifically and reliably measure the level of consciousness in vegetative and minimally conscious States? Rasch analysis of the coma recovery scale-revised. Arch Phys Med Rehabil 2013;94:527– 535.e1.

PFD-SENTINEL: the first screening tool for pelvic floor dysfunction in female athletes

Introduction

Evidence suggests the prevalence of Pelvic Floor Dysfunction (PFD) among female athletes is high, with urinary incontinence being particularly common.
Female athletes’ knowledge of PFD is low, and few discuss their condition with medical professionals. Many healthcare providers are also unaware of the potential dysfunction and do not screen for it. This lack of recognition can lead to worsening symptoms, negative impact on performance, and athletes withdrawing from sports.
Although screening tools exist for other conditions, there is currently no tool available for PFD screening specifically for sports medicine clinicians.
This study aimed to develop a screening tool for PFD in female athletes for use by sports medicine clinicians (e.g musculoskeletal/sports physiotherapists, sports and exercise medicine physicians) which guides referral to a PFD specialist (e.g., pelvic floor/women’s health physiotherapist, gynecologist, uro-gynecologist, urologist) through a Delphi consensus.

Methods

A team of Italian researchers developed a screening tool using a Delphi modified consensus through a web-based survey. All complete information are available along the published article.
The target population for the tool is female athletes of any age, performance level, and participating in any type of sport. The clinical condition being considered is any type of PFD. Risk factors and sports-related characteristics (items) associated with PFD in female athletes were extracted from a preliminary search in MEDLINE. Experts’ recruitment relied on non-random, purposive sampling through a literature scan of MEDLINE. Then, an online two-round modified Delphi technique was used to establish agreement among experts on the identified items using a 5-point Likert scale. A consensus was set at 67% agreement or disagreement with a proposal.
Item scores were summarised as appropriate (e.g, frequency and proportions) accompanied by a narrative summary of findings and suggestions.

Results

Among 77 experts, forty-one respondents took part in Round 1 and 34 in Round 2, representing 53.2% (41/77) and 44.2% (34/77) of participants.
Females, Italians, and physiotherapists were the most prevalent sex, nationality, and educational background, respectively. Most participants were currently working as clinicians and researchers (n=22; 53.6%) and reported considerable experience.
Six statements gained immediate consensus by Round 1 and twenty-eight out thirty-seven items were included in the tool. Participants agreed to identify 50% of items (n=14) as a benchmark of total item score for suggesting referral to a PFD specialist. Five out of six symptoms reached the minimum agreement. The majority of experts chose the Pelvic Floor Dysfunction – ScrEeNing Tool IN fEmale athLetes (PFD-SENTINEL) as the official name for the tool (n=16; 47.1%).
Figure 1 shows all the items and PFD symptoms that are included in the PFD-SENTINEL, as well as the clinical algorithm (Figure 2).

Discussion and Conclusion

This 2-round Delphi study involving experts worldwide reached a multidisciplinary consensus on the proposal of the first screening tool for PFD in female athletes. The tool aims to address the barriers in identifying the prevalence and burden of PFD in this population.
The PFD-SENTINEL is a simple and user-friendly tool consisting of two sections to screen for symptoms and risk factors associated with PFD and provides a scoring algorithm to determine whether referral to a specialist is necessary. The tool should be administered regularly and can be used during the pre-season, after enforced breaks, and among athletes returning to sport after pregnancy.
However, education of clinicians, as well as a confidential setting for using the tool, may be necessary. The study has strengths in its novelty and transparency, but limitations include the representativeness of the expert panel. Further validation studies are necessary to test the screening tool accuracy.

REFERENCES

Giagio S, Salvioli S, Innocenti T, et al. PFD-SENTINEL: Development of a screening tool for pelvic floor dysfunction in female athletes through an international Delphi consensus [published online ahead of print, 2022 Dec 14]. Br J Sports Med. 2022;bjsports-2022-105985. doi:10.1136/bjsports-2022-105985

Abrams P, Cardozo L, Wagg A, et al. Incontinence. 6th Editio. ICI-ICS. International Continence Society, Bristol UK 2017.

Giagio S, Salvioli S, Pillastrini P, et al. Sport and pelvic floor dysfunction in male and female athletes: A scoping review. Neurourol Urodyn 2021;40:55–64. doi:10.1002/nau.24564

McKenna HP. The Delphi technique: a worthwhile research approach for nursing? J Adv Nurs 1994;19:1221–5. doi:https://doi.org/10.1111/j.1365-2648.1994.tb01207.x

Mobility Scale for Acute Patients: validity and reliability of the Italian scale

Introduction

Many well-known functional scales include items of mobility and have been validated for assessing functional status in the rehabilitation setting but propose measures of complex items, that would be expected months after an acute event. The Mobility Scale for Acute Stroke Patients (MSAS) by Simondson et al. (1996) was developed to respond to the need for a scale that addresses the specific needs of neurological patients in the acute setting. Although the MSAS was developed to specifically discriminate between the lower levels of mobility in acute stroke patients in the first two weeks post-onset, we thought it could also be a valid tool to be used for the assessment of patients in the early sub-acute phase of stroke. The present study aims to develop and validate a version of the MSAS in Italian.

Methods

The English version of the MSAS was translated into Italian according to international guidelines. Later were tested the internal consistency, concurrent validity, reliability, and responsiveness properties of the scale. The recruited patients were divided into two groups. For the scute (AC) group we recruited patients admitted for rehabilitation within 14 days of the stroke onset, while for the sub-acute (SA) group, we recruited patients admitted for rehabilitation between 15 and 90 days after the stroke. Each patient was tested twice after 24 hours by the same physical therapist to evaluate the test-retest reliability.  To assess inter-rater reliability, two blinded physical therapists independently evaluated the same person.  To investigate the responsiveness the MSAS was administered at the time of admission and two (acute) and seven (sub-acute) weeks later, at the discharge, to a sub-group of 44 patients.

Results

Internal consistency results showed statistically significant data for both groups. Cronbach’s alpha for individuals in AC and SA phases showed values equal to 0.96, and the alpha deleted analysis (Table 1) demonstrates that all the items on the scale have reason to exist. Concurrent validity showed statistically significant data for both populations. Indeed, we obtained statistically significant data for all scales (Table 2). The Italian version of the MSAS showed significant and high intra-rater reliabilities (all ICCs ≥ 0.75) for both the AC and SA sub-groups (Table 3).  The MSAS also showed excellent test-retest reliabilities (all ICCs ≥ 0.90) for the AC and SA sub-groups (Table 4). The reactivity of the scale, evaluated through the Student’s ts for paired samples on the sub-sample of 42 individuals, showed statistically significant improvements over time for all items and the total scale (Table 5).

Discussion and Conclusion

The results show that the scale is stable and reliable both in the evaluation after 24 hours and in the evaluation between different operators. A high internal consistency and a strong correlation between the scales used as Gold Standard and the MSAS were found for both acute and sub-acute samples. The scale has also proved to be able to evaluate the improvement obtained by patients following the rehabilitation treatments carried out.

REFERENCES

• Simondson J, Goldie P, Brock K, Nosworthy J. The Mobility Scale for Acute Stroke Patients: intra-rater and interrater reliability. Clin Rehabil 1996; 10: 295–300. F
• Simondson JA, Goldie P, Greenwood KM. The Mobility Scale for Acute Stroke Patients: concurrent validity. Rehabil. 2003 Aug;17(5):558-64. doi: 10.1191/0269215503cr650oa. PMID: 12952164.
• Wild D, Grove A, Martin M, Eremenco S, McElroy S, et al. (2005) Principles of good practice for the translation and cultural adaptation process for patient-reported outcome (PRO) measures: report of the ISPOR task forces for translation and cultural Value Health 8: 94-104.

Early rehabilitation program with augmented reality and gamification after surgery in patients with lower limb fractures

Introduction

The rehabilitative pathway following surgery for lower limb fracture can be lengthy, significantly impacting both quality of life and work [ 1 ]. Weight-bearing guidelines are dependent on the operating surgeon, and typically, physiotherapy and functional retraining begin after a period of immobilization and weight-bearing restriction.

After this period, patients often tend to underutilize the affected limb in functional tasks due to movement-related fear [ 2 ] or excessive control over the injured limb.

Incorporating immersive and gamified exercise through augmented reality allows patients to shift the load correctly between both lower limbs. The challenging context serves as a catalyst in increasing  patient’s motivation to achieve their goals [ 3 ]. Furthermore, rehabilitation exergames contribute to increase patient engagement, thereby reducing the repetitiveness of the exercises.

Methods

Nineteen patients, ranging in age from 18 to 65 years, without severe comorbidities, and who were permitted early weight-bearing after surgery, were enrolled in the study.

Eleven patients (control group) followed the standard rehabilitation protocol provided by the regional healthcare system, which included traditional physiotherapy. Conversely, eight patients (study group) participated in an early rehabilitation program (started on average 5 days post-surgery) that incorporated physiotherapy with exercises using the D-Wall Tecnobody® system. The exergames involved controlled weight transfers through pelvic movement, as well as the simulation of more complex gestures with the upper limbs, requiring proper control of the base of support.

At 6 weeks and 3 months post-surgery, functional clinical questionnaires were administered. Simultaneously, the return to autonomy, work, and sports activities were investigated.

Results

At 6 weeks, the study group achieved complete (100%) return to full weight-bearing and autonomy, while 63% of patients in control group achieved full weight-bearing and 81% autonomy. In the study group, 66% had returned to work and 42% to sports activities, compared to 33% returning to work and 9% returning to sports in the control group. The groups showed statistical differences in NRS (p-value 0,046) and WOMAC (p-value 0,0013) questionnaires, with better scores in the study group. At 3 months, the difference between groups persisted in NRS score (p-value 0,0025), while the results of other questionnaires aligned, indicating functional recovery in both groups. No complications occurred.

Overall, patients undergoing early physiotherapy intervention had an average of 11.42 physiotherapy treatments, while patients in the control group required the prescription of multiple physiotherapy session to achieve complete recovery, with an average of 28.18 (p-value 0,0012).

Discussion and Conclusion

The availability of current rehabilitation technologies, such as gamified exercises in augmented reality, offers the opportunity to transform traditional physiotherapy into a dynamic process. This allows patients to gain immediate awareness of the load-bearing possibilities on the operated limb within more complex movements, without developing protective mechanisms or avoiding the use of the fractured limb. This has the potential to decrease the inactivity period, the number of prescribed physiotherapy sessions, and the economic impact for patients receiving early weight-bearing recommendations after surgery.

REFERENCES

[ 1 ] Black JDJ et al., Early weight-bearing in operatively fixed ankle fractures: A systematic review, The Foot, 2013;23(2):78–85

[ 2 ] Steven JL et al., Pain-related fear, catastrophizing and pain in the recovery from a fracture, Scandinavian Journal of Pain, 2010 ;1(1):38–42

[ 3 ] S. Sandrone et al., Gamification and game-based education in neurology and neuroscience: application, challenges and opportunities, Brain Disorders, Vol. 1, 2021, 100008, ISSN 2666-4593

HOME-BASED EXERGAMES TO IMPROVE COGNITIVE FUNCTION IN MULTIPLE SCLEROSIS: A MULTICENTRE, RANDOMISED, SHAM-CONTROLLED, SINGLE-BLIND, PARALLEL ARM STUDY (EXTREMUS)

Introduction

People with Multiple Sclerosis (PwMS) often experience coexisting cognitive and motor dysfunctions that require both cognitive and motor rehabilitation. The set-up of a tailored approach encompassing two different forms of rehabilitation (for motor and cognitive problems) can be time-consuming and expensive. Therefore, the provision of a single rehabilitation strategy that can address both cognitive and motor issues remains highly desirable.Exergaming is an emerging tool in neurorehabilitation that incorporates goal-based training and gross motor exercise, thus having the potential for improving both cognitive and automatic components of motor control by exploiting adaptive plasticity. The aim of this study was to verify the hypothesis that exergames and working memory trainings were equally superior to a sham intervention on information processing speed and that exergames were superior to both working memory training and sham intervention on walking endurance and dynamic balance.

Methods

We selected 92 PwMS who had a cognitive impairment defined based on Symbol Digit Modalities Test (SDMT) score and with the ability to stand upright for at least 180 seconds.Subjects were randomized in a one-to-one-to-one ratio to sham intervention or working memory training or exergames. Both the sham intervention and the working memory training were delivered by COGNI-TRAcK that is a handheld application for tablets. Exergaming was delivered by the Wii Fit Plus package.All interventions were standardized in terms of setting(at home), intensity(30 minutes per session), frequency(5 sessions per week) and duration(8 weeks).Study assessments were done at baseline (T0) and soon after the end of intervention (T1).The SDMT was the primary endpoint. The secondary outcomes were Brief International Cognitive Assessment for MS (BICAMS), Stroop test, 2 Minute Walk Test (2MWT), Timed Up-and-Go test (TUG), 9-Hole Peg Test (9HPT) and patient-reported

Results

Regarding the primary outcome, both exergames and adaptive COGNI-TRAcK were superior to sham on SDMT after the eight-week intervention (T1).In particular, the Effect Size (ES) by Cohen’s d considering the change between the score at T1 and T0 (T1-T0) was 0.78 and 0.53 respectively in COGNI-TRAcK adaptive and exergames groups,with a p < 0.05 versus sham in both groups.Only the adaptive COGNI-TRAcK was superior to sham intervention on verbal learning and memory (ES= 0.71) and only exergames were superior to sham on executive functions explored with the Stroop test (ES=0.55) with p < 0.05 versus sham.Only the exergames group had significant improvement in both 2MWT (ES=0.54) and TUG (ES=0.71) as compared with the sham intervention(p < 0.05 versus sham).Regarding patient-reported outcomes, we found a beneficial effect only with exergames group that experienced less impact of MS.A significant reduction of the total Modified Fatigue Impact Scale score with an ES=0.55 was found.

Discussion and Conclusion

Exergames can be regarded as a “pay-one-get-two” deal, as they can improve both the motor and cognitive domains, especially attention and executive function. On the other hand, we confirm the beneficial effect of working-memory training on a wide range of cognitive aspects, but we found no effect on motor outcomes or patient-reported outcomes (thereby, there is no far transfer for working-memory training).Moreover, other data analyses are in progress to explore adherence to intervention, the long-term effect of intervention, the safety of exergames with special attention to accidental falls, and several predictors of outcomes including sleep quality, personality trait, cognitive reserve and motor reserve.

REFERENCES

-Stanmore E, Stubbs B, Vancampfort D, de Bruin ED, Firth J. The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials. Neurosci Biobehav Rev. 2017 Jul;78:34-43. doi: 10.1016/j.neubiorev.2017.04.011. Epub 2017 Apr 23. PMID: 28442405.

-Prosperini L, Fortuna D, Giannì C, Leonardi L, Marchetti MR, Pozzilli C. Home-based balance training using the Wii balance board: a randomized, crossover pilot study in multiple sclerosis. Neurorehabil Neural Repair. 2013 Jul-Aug;27(6):516-25. doi: 10.1177/1545968313478484. Epub 2013 Mar 11. PMID: 23478168.