Effect of botulinum toxin injection on clinical and instrumental measures of walking ability in post-stroke patients with equinus foot deviation. A prospective cohort study.

Introduction

Equinus foot deviation (EFD) is the most frequent lower limb acquired deformity in stroke survivors. It affects ankle stability during the stance phase of gait and hinders foot clearance during swing, increasing the risk of falling and reducing both participation and quality of life. EFD may result from several factors, including the presence of triceps surae spasticity. Botulinum toxin (BoNT-A) is the first-line treatment for spasticity and is typically associated with adjuvant treatments, inclusive of physiotherapy, to potentiate its effect [ 1 ]. This study aims to describe the effects of BoNT-A injection alone at the triceps surae of post-stroke patients with EFD on ankle ROM and spasticity, loading and propulsive abilities during gait, and on the patient’s overall walking ability.

Methods

Prospective cohort study. Inclusion criteria: hemiparesis consequent to a first stroke, >1 y from the lesion, age <80 y, ability to walk for at least 10 m without help, Modified Tardieu Scale (MTS) ≥ 1 at the calf muscles, treatment by BoNT-A at the triceps surae with no physiotherapy thereafter. Exclusion criteria: cognitive barriers, orthopaedic pathologies at the lower limbs, ongoing antispastic therapy. Patients were assessed 1 week before and 4-6 weeks after BoNT-A injection. Clinical assessment included: ankle maximum passive dorsiflexion with the knee extended and flexed (pDF_KE, pDF_KF), MTS score and spasticity angle (SA), walking speed, FAC, WHS, and RMI. Dynamic loading ability (DLA) and dynamic propulsive ability (DPA) were computed from ground reaction force (GRF) data [ 2 ]. DLA is the mean value of the vertical component of the GRF. DPA is the mean value of the positive part of the fore-aft component [ 2 ]. The Wilcoxon test was used to compare paired variables.

Results

20 adult patients with chronic stroke and EFD, 4F/16M, age 42 (15) years were included. In baseline, pDF_KE was -4 (7)°, pDF_KF was 4 (8)°, median MTS score was 2 in both conditions (KE, KF), spasticity angle was 9 (5)° at the gastro-soleus complex (KE) and 9 (7)° at the soleus (KF). FAC ranged between 3 and 4, WHS between 3 and 6 and RMI between 5 and 15. On average, pDF_KE and pDF_KF did not vary after treatment (p=0.15, p=0.54). MTS score and SA did not vary at the soleus (p=0.23, p=0.18), while a nearly significant improvement was found at the gastro-soleus complex for both MTS score, reduced by 1 point (p=0.065), and SA, reduced by 3° (p=0.053). Walking speed was 33 (12) %height/s before treatment and 36 (14) %height/s after treatment (p=0.173). DLA minimally increased from 66 (8) to 68 (9) %BW (p=0.053). DPA remained stable at 3 (2) %BW (p=0.68). FAC, WHS, and RMI did not vary (p>0.78). Walking speed improved in 6 subjects, was stable in 11, and worsened in 3 cases.

Discussion and Conclusion

A subset of patients only had an improvement after treatment, while the remaining subjects did not vary or even worsened. This explains the lack of statistical significance in the results. In our study, walking speed increased in only 1/3 of the patients after treatment, with limited or no effect on functional scales. On the one hand, this may depend on the lack of adjunctive physiotherapy following BoNT-A, which is instead recommended. On the other hand, a preliminary assessment of calf muscles by sEMG during walking might have modified the treatment selection, as in [ 3 ]. Finally, GRF-based indices can be a valid compromise to obtain an instrumental evaluation over time of the effects of BoNT-A with extremely low evaluation times and costs. Patient recruitment is ongoing to increase the sample size and the consequent statistical power.

REFERENCES

[ 1 ] Picelli A et al. Ann Phys Rehabil Med 2019;62(4):291-296

[ 2 ] Campanini I et al. Gait Posture 2009;30(2):127-31

[ 3 ] Ferrarin M et al. Eur J Phys Rehabil Med 2015;51(2):171-84

Walking and fatigue in People with Multiple Sclerosis: Gait compensatory strategies to control clearance during the mid-swing phase. A qualitative study.

Introduction

People with Multiple Sclerosis (PwMS) commonly experience falls or near falls, of which one-third seem to be associated with fatigue or tripping. Lately, different studies have inquired about changes in gait parameters related to fatigue, but none have depicted the clinical compensations in the swinging limb that PwMS implement when they get fatigued, to reduce the risk of tripping. The present study tries to describe the strategies that PwMS carry out to control the clearance of the swinging limb when they get fatigued.

Methods

Thirty-two PwMS (EDSS 3.0±1.5) and 8 healthy subjects (HS) were recruited. Kinematic data were collected using a SMART-D motion capture system (BTS, Milano, Italy) with LAMB protocol. Subjects were asked to walk continuously at a steady cadence (spontaneous + 15%) suggested by a metronome. Every minute physical exertion was recorded on the Borg scale (RPE); the test ended as the subject reached a score of 17 (very hard).

We estimated the trend over time for clearance, foot drop, and lower limb length (LL), calculated as the distance between the ipsilateral anterior superior iliac spine and lateral malleolus. For each variable, we derived the slope trends and considered the slope coefficient (k) to describe our findings.

Finite mixture models were used to provide a cluster analysis: a) Univariate model of k clearance; b) Multivariate model of k-LL and k-footdrop, considering the subjects with a negative clearance according to the previous univariate analysis.

Results

PwMS walked less time (13.9±10.22 vs 30.0±1 min) HS reaching an RPE of 17, while HS walked 30 minutes reaching an RPE≤11. The cluster analysis of the k clearance showed 2 different patterns (Figure 1): 1a) showing a minimal clearance variability -0.11(0.03)mm/min (light-blue dots); 1b) a higher clearance variability -0.62(1.1)mm/min (red dots).

The multivariate model (Figure 2), considering subjects in 1b) and with a negative k-clearance, showed 3 different patterns related to k-LL and k-footdrop: the first group (green triangles) had an increased LL over time (k-LL=4.8(0.5)mm/min) and a reduction in the foot drop (k-footdrop=-2.0 (0.5)mm/min). The second group (red squares) showed a minimal variation in both parameters (k-footdrop=0.2(1.0)mm/min, k-LL = 0.3(1.0)mm/min). The third group (blue dots) had an increased k-footdrop (5.6(2.8)mm/min) associated with a reduction in the LL (k-LL=-4.8 (2.8)mm/min).

Discussion and Conclusion

The present findings seem to have the potential to better guide gait rehabilitation. In subjects with a stable clearance, the fatiguability seems associated more to deconditioning and general stability. For subjects who increase clearance (over-compensating), the treatment could be aimed toward more energy-conservative strategies. While, for subjects more at risk of tripping we found three different patterns: a group had a progressive deficit in ankle dorsiflexion partially compensated by a shortening of the limb in flight; another group had a slight change in both; finally, a third group had a deficit related to limb length in flight partially compensated by an increase in ankle dorsiflexion. Thus, rehabilitation intervention could be directed to proximal or, distal muscle function or both, and ankle-orthosis prescription could be suggested to subjects with a real need. Other factors (eg. trunk, pelvis) should be explored in future studies.

REFERENCES

Comber L, Galvin R, Coote S. Gait deficits in people with multiple sclerosis: A systematic review and meta-analysis. Gait Posture. 2017 Jan;51:25-35. doi: 10.1016/j.gaitpost.2016.09.026. Epub 2016 Sep 26. PMID: 27693958.

Broscheid KC, Behrens M, Bilgin-Egner P, Peters A, Dettmers C, Jöbges M, Schega L. Instrumented Assessment of Motor Performance Fatigability During the 6-Min Walk Test in Mildly Affected People With Multiple Sclerosis. Front Neurol. 2022 May 9;13:802516. doi: 10.3389/fneur.2022.802516. PMID: 35614920; PMCID: PMC9125148.

Fritz NE, Eloyan A, Baynes M, Newsome SD, Calabresi PA, Zackowski KM. Distinguishing among multiple sclerosis fallers, near-fallers and non-fallers. Mult Scler Relat Disord. 2018 Jan;19:99-104. doi: 10.1016/j.msard.2017.11.019. Epub 2017 Nov 22. PMID: 29182996; PMCID: PMC5803437.

ACTION OBSERVATION AND MOTOR IMAGERY IMPROVE MOTOR IMAGERY ABILITIES IN PATIENTS WITH PARKINSON’S DISEASE – A FUNCTIONAL MRI STUDY

Introduction

Motor imagery (MI) is a motor-learning skill that can be affected in patients with Parkinson’s disease (PD) [1, 2]. We aimed at assessing MI and brain functional changes after an action observation training (AOT) and MI training associated with gait/balance exercises in PD patients with postural instability and gait disorders (PD-PIGD).

Methods

Twenty-five PD-PIGD patients were randomized into two groups: the DUAL-TASK+AOT-MI group performed a 6week gait/balance training combined with AOT-MI; the DUAL-TASK group performed the same exercises while watching landscape videos. Before and after training, MI was assessed using the Kinesthetic-and-Visual-Imagery Questionnaire (KVIQ) and a MI functional MRI (fMRI) task. During fMRI, subjects were asked to watch first-person perspective videos representing gait/balance tasks and mentally simulate to perform them. At baseline patients were compared with 23 healthy controls.

Results

At baseline, there were no significant differences between groups in the MI scores. Both patient groups increased kinesthetic MI score after training, while only DUAL-TASK+AOT-MI group improved in visual MI and total KVIQ scores. At baseline, both PD groups showed reduced fMRI activity of sensorimotor, temporal and cerebellar areas relative to controls. After training, DUAL-TASK+AOT-MI patients increased activity of anterior cingulate, fronto-temporal and motor cerebellar areas, and reduced the recruitment of cognitive cerebellar regions. DUAL-TASK group showed increased recruitment of occipito-temporal areas and reduced activity of cerebellum crus-I. DUAL-TASK+AOT-MI relative to DUAL-TASK group had increased activity of cerebellum VIII-IX. In DUAL-TASK+AOT-MI group, KVIQ improvement correlated with increased activity of cerebellum IX and anterior cingulate, and with reduced activity of crus-I.

Discussion and Conclusion

AOT-MI improves MI abilities in PD-PIGD patients, promoting the functional plasticity of brain areas involved in MI processes and gait/balance control.

REFERENCES

[ 1 ] G. Abbruzzese, et al. Action Observation and Motor Imagery: Innovative Cognitive Tools in the Rehabilitation of Parkinson’s Disease, Parkinson’s Disease. 2015. Doi: 10.1155/2015/124214

[ 2 ] E. Sarasso, et al. Action Observation and Motor Imagery Improve Dual Task in Parkinson’s Disease: A Clinical/fMRI Study. Movement Disorders. 2021. Doi: 10.1002/mds.28717

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.

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.

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.

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.

Psychometric properties of the Fugl-Meyer Assessment (FMA): a systematic review with meta-analysis

Introduction

Stroke is the second cause of death in the world, and the main cause of disability. Using reliable, valid and responsive instrument to assess the sensory and motor function in patients with stroke is crucial in clinical practice and research. Fugl-Meyer Assessment (FMA) is widespread measurement instrument, and it is composed by five domains for Upper Extremity (FMA-UE) and Lower Extremity (FMA-LE), assessing motor activity, sensory response, balance, joint range of motion, and joint pain, for a total of 155 items. Each item is scored by 3-point Likert scale (i..e, 0=unable to perform, 1=performs partially, 2= performs totally) and the maximum score is 226 points. However,  no systematic review is available that summaries evidence on its psychometric properties. Therefore, the aim of this study is to perform a systematic reviews with meta-analysis to assess the psychometric properties (i.e., reliability, validity, responsiveness) of the FMA.

Methods

A literature search was performed in PubMed, EMBASE and CINAHL between the inception to May 2022 with MeSH terms and free words text, according to the COSMIN recommendation. Studies were included if they assessing the psychometric properties of the FMA in patients with stroke. Screening, eligibility, and data extraction processes were performed by two independent reviewers and disagreements were resolved by a third reviewer. Fixed and random effect models were considered for the meta-analysis, and the statistical heterogeneity between the studies was evaluated by I² statistics.

Results

Out of 3193 articles retrieved, 25 met eligibility criteria for systematic review and 23 were included in the meta-analysis (Figure 1). Detailed results of meta-analysis findings are reported in Figure 2 and Figure 3. For intra-rater reliability, the ICC was >0.90, except for some subscales (e.g., FMA joint pain:  ICC=0.79). Also, for inter-rater reliability, the ICC was >0.90 for all scales except one (i.e., FMA-LE Passive joint motion, ICC= 0.87). We found several high values for measurement error ​​for the subscales with few items (e.g. FMA-LE Sensation 0.12 points); on the other hand we found a reasonable measurement for FMA Total Score. For construct validity from weak to strong correlations were found between FMA subscale and different measurement instruments. Few study assessed the responsiveness of two FMA subscales.

Discussion and Conclusion

FMA subscales proved to be reliable and valid; however, the measurement error was high for some subscales. Evidence on FMA subscales responsiveness are limited. FMA subscales can be used to assess the sensory and motor function in patients with stroke in several measurement between the same assessor or with different assessors. However, our findings suggest to use care when using FMA subscales for capture the change of sensory and motor function after a treatment in patients with stroke. Future studies should fill in this gap.

REFERENCES

Fugl-Meyer AR, et al. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

Terwee CB, et al. Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments. Qual Life Res. 2009 Oct;18(8):1115-23.

Terwee CB, et al. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007;60(1):34-42.

Multidisciplinary Approach Based on Frailty Screening in Liver Transplant Candidates at ISMETT: Analysis for Personalized Interventions and Improved Transplant Outcomes

Introduction

Frailty is a debilitating condition in organ transplant candidates. Accurate screening would enhance resource management during the waiting period.

Benefits of screening:

• Improved quality of life
• Impact on healthcare costs
• Precise identification of high-risk patients

Accurate frailty assessment provides indications for activation of territorial services with preventive measures, such as functional recovery programs and balanced diets.

According to the “National Transplant Center” for 2021 (3), there were 2,679 liver transplant registrations, with 1,388 transplants and 8.7% mortality on the waiting list, with a 15.5% drop-out rate.

Identifying frail patients optimizes resource allocation during the waiting period. The study’s aim was to map the liver transplant candidate population at ISMETT, identifying the most fragile subjects.

Methods

ISMETT is a transplant institute in Palermo. In the 2022 report, 91 liver transplants were performed, including 75 from deceased donors. Transplant activity began in 1998, with cadaveric, living donor, and split liver programs.

For liver transplant candidates, the physiotherapist’s evaluation was introduced into the assessment protocol, complemented by the “Liver Frailty Index” test since April 2021. Patients are stratified into three classes: “frail,” “pre-frail,” and “robust.”

Based on the test, frailty reassessment is scheduled at 1, 3, and 6 months for each class, with specific indications for activities and care settings, including ADI service activation, long-term hospitalization, or self-managed physiotherapy exercises using a brochure provided after patient instruction.

Data were collected in an Excel database, and statistical analysis was performed using means, standard deviations, minimum and maximum values, and stratification by gender

Results

A total of 379 consecutive patients were evaluated, excluding 6 due to inadequate test conditions. Male prevalence: 76.1% (n = 284), mean age: 55.23 years (range: 21-71, SD: 10.36), with no significant gender differences. Frailty assessment: mean 3.74 (range: 1.68-6.74, SD: 0.96), with no significant gender differences.

Distribution of patients by frailty classes: pre-frail (n = 183, 49.1%), frail (18.2%, n = 68), with no gender differences.

Analysis of individual test items: 94.9% passed the single-leg balance test, while 7.8% were unable to perform the tandem position test.

Therapeutic indication: A self-managed recovery exercise program through a brochure with predefined or patient-selected exercises was used for 54.2% of evaluated patients.

18.2% were recommended ADI service activation, with 7 preferably hospitalized if available. 26% received no additional activity indications (robust patients)

Discussion and Conclusion

The conclusions of our study allowed an accurate analysis of frailty in liver transplant candidates at ISMETT. Implementing the physiotherapist evaluation protocol and utilizing the Liver Frailty Index provided valuable insights for personalized interventions and a more detailed understanding of liver transplant recipients’ characteristics

A multidisciplinary approach based on frailty screening proves to be a valuable tool for enhancing management and customization of care for liver transplant candidates, aiming to adopt personalized interventions and improve transplant outcomes. However, the current data are partial and lacking in terms of transplant survival and adherence to therapeutic indications, as well as the actual support of territorial services.

Our study offers a crucial knowledge base, but further research and joint efforts are necessary to ensure optimal and personalized treatment for liver transplant candidates

REFERENCES

Haugen CE, McAdams-DeMarco M, Holscher CM, Ying H, Gurakar AO, Garonzik-Wang J, et al. Multicenter Study of Age, Frailty, and Waitlist Mortality Among Liver Transplant Candidates. Ann Surg. 2020 Jun;271(6):1132–6.

Centro Nazionale Trapianti. Rapporto annuale [ Internet ]. Available from: https://www.trapianti.salute.gov.it/imgs/C_17_cntPubblicazioni_506_allegato.pdf

Kwong AJ, Ebel NH, Kim WR, Lake JR, Smith JM, Schladt DP, et al. OPTN/SRTR 2020 Annual Data Report: Liver. Am J Transplant Off J Am Soc Transplant Am Soc Transpl Surg. 2022 Mar;22 Suppl 2:204–309

Lai JC, Covinsky KE, Dodge JL, Boscardin WJ, Segev DL, Roberts JP, et al. Development of a novel frailty index to predict mortality in patients with end‐stage liver disease. Hepatology. 2017 Aug;66(2):564–74

Wearable devices to Improve Physical Activity: An Overview of Systematic Reviews

Introduction

Physical activity provides benefits in the prevention and treatment of many conditions. A low proportion of the population meets the suggested evidence-based level of physical activity. Wearable devices might contribute to increase physical activity. This study aimed to evaluate the efficacy of wearable devices in increasing physical activity in adults.

Methods

We performed an Overview of Systematic Reviews (SRs). The review protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) database (CRD42022339140). We searched PubMed, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, MedRxiv, Rxiv and bioRxiv databases up to February 5^th, 2023. SRs that evaluated the efficacy of interventions with wearable devices to increase physical activity in adults aged over 18 years. The primary outcome was physical activity measured as the number of steps per day, minutes of moderate to vigorous physical activity (MVPA) and sedentary behaviour (SB).

Results

We included 51 SRs, of which 38 included meta-analyses, and 302 unique primary studies were detected (FIGURE 1). Overall, 72.5% of SRs were rated as critically low quality. With a slight overlap of primary studies (CCA: 3.87% in steps per day, 2.78% in MVPA, 4.06% in SB) and low to moderate certainty of the evidence, wearable devices may increase PA with a median of 1312.23 (IQR 627-1854) steps per day and 12.56 (IQR 7.22 to 48.5) minutes of MVPA with clinical relevance in adults with or without comorbidities (FIGURE 2). Scattered clinically and statistically effect sizes for SB were reported in few SRs and in older adults.

Discussion and Conclusion

Our findings suggest that wearable devices represent valuable options for improving physical activity levels in middle-aged, with or without comorbidities. Further studies are needed to investigate the effects of wearable devices in different follow-up lengths, among older adults and the role of other intervention components.

REFERENCES

• World Health Organization. Global action plan on physical activity 2018–2030: more active people for a healthier world. 2018
• Guthold R, Stevens GA, Riley LM, Bull FC. Worldwide trends in insufficient physical activity from 2001 to 2016: a pooled analysis of 358 population-based surveys with 1·9 million participants. Lancet Glob Health. 2018;6(10):e1077-e86.