Study for the validation of the FeetMe® integrated sensor insole system compared to GAITRite® system to assess gait characteristics in patients with multiple sclerosis.

OBJECTIVE: To determine the concordance and statistical precision in gait velocity in people with multiple sclerosis (pwMS), measured with FeetMe® (insoles with pressure and motion sensors) compared with GAITRite® (classic reference system of gait analysis) in the timed 25-Feet Walk test (T25WT). METHODS: This observational, cross-sectional, prospective, single center study was conducted between September-2018 and April-2019 in pwMS aged 18-55 years, with Expanded Disability Status Scale (EDSS) 0-6.5 and relapse free ≥30 days at baseline. Primary endpoint was gait velocity. Secondary endpoints were ambulation time, cadence, and stride length assessment, while the correlation between gait variables and the clinical parameters of MS subjects was assessed as an exploratory endpoint. RESULTS: A total of 207 MS subjects were enrolled, of whom, 205 were considered in primary analysis. Most subjects were women (66.8%) and had relapsing-remitting MS (RRMS) (82.9%), with overall mean (standard deviation [SD]) age of 41.5 (8.0) year and EDSS 3.1 (2.0). There was a statistically significant (p<0.0001) and strong agreement (intra-class correlation coefficient (ICC) >0.830) in gait velocity, ambulation time and cadence assessment between FeetMe® and GAITRite®. CONCLUSIONS: Agreement between devices was strong (ICC≥0.800). FeetMe® is the first validated wearable medical device that allows gait monitoring in MS subjects, being potentially able to assess disease activity, progression, and treatment response.

Effects of pulsed electromagnetic field therapy on fatigue, walking performance, depression, and quality of life in adults with multiple sclerosis: a randomized placebo-controlled trial.

BACKGROUND: Multiple sclerosis has a great disability burden. Management of the disease is complex, and patients often seek new conservative approaches. OBJECTIVE: To investigate the effect of low-frequency pulsed electromagnetic field (PEMF) therapy, compared to placebo, on the level of fatigue, walking performance, symptoms of depression, and quality of life (QOL) in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS: Forty-four adults with RRMS and minimal to significant disability were randomly assigned to a 4-week protocol using a PEMF or a placebo whole-body mat. The PEMF group were initially treated with 15Hz frequency, gradually increased to 30Hz (intensity between 25-35µT). The primary outcome was fatigue, assessed with the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS). Secondary measures included walking function (GAITRite system and Timed 25-Foot Walk test), the Beck Depression Inventory-II, and the Multiple Sclerosis International Quality of Life Questionnaire. Data were collected at baseline, after intervention, and at 3-months post-intervention (follow-up). RESULTS: There were no differences between groups for changes in fatigue symptoms from baseline to end of intervention (mean and 95% confidence interval FSS: -0.6, 95%CI: -1.3, 0.1; MFIS: -5.4, 95% CI: -15.1, 4.4) or at follow-up (FSS: -0.6, 95% CI: -1.4, 0.2; MFIS: -2.1, 95% CI: -10.9, 6.8). Similarly, both groups did not differ for any of the secondary outcomes at post-intervention or follow-up. CONCLUSIONS: Low-frequency PEMF therapy is no more effective than placebo to produce changes in fatigue, gait performance, severity of depression, and QOL in people with RRMS and minimal to significant disability.

Gait pattern changes after six-minute walk test in persons with multiple sclerosis.

OBJECTIVE: To examine the effect of induced fatigue on spatiotemporal gait parameters in persons with multiple sclerosis (PwMS) by using 6-min walk test (6MWT). METHODS: A cross-sectional study with a control group (25 healthy persons) was performed. Fifty-six PwMS (37 female) were divided into three groups according to their level of disability, as measured by the expanded disability status scale (EDSS): mild (n = 23, EDSS = 1.0-3.5), moderate (n = 19, EDSS = 4.0-5.5), and severe (n = 12, EDSS = 6.0-6.5). Spatiotemporal gait parameters were measured by the GAITRite electronic walkway before and after 6MWT performance. In addition, to determine the level of fatigue in PwMS, the participants completed the questionnaire modified fatigue impact scale (MFIS) before performing the 6MWT. Statistical analyses were performed to compare intragroup and intergroup differences. RESULTS: Fatigue level was lower in the mild (37.6 ± 20.5) versus moderate (54.3 ± 17.2) versus severe (53.6 ± 12.9) groups (p < 0.05). Significant differences were found among all the groups in terms of the distance walked during the 6MWT (p = 0.001) and of the spatiotemporal gait parameters: gait velocity (cm/s), cadence (steps/min), and step length (cm) decreased and, on the contrary, step time (sec), stance, and double support time (% gait cycle) increased when EDSS scores were higher (p < 0.05). The percentage of change (%) in the spatiotemporal gait parameters, after 6MWT performance, was statistically significant in the moderate and severe groups: gait velocity (-8.8%, -25.9%) and step length (-6.5%, -13.4%) decreased, whereas step time (3.0%, 15.0%), double support time (8.8%, 19.1%), step time asymmetry (32.1%, 64.0%), and single support asymmetry (60.0%, 74.7%) increased (p < 0.05). CONCLUSIONS: Gait pattern worsen after performing a walking-induced fatigue test, such as 6MWT, in moderate-severe PwMS (EDSS ≥ 4.0). Identifying these gait alterations will allow physiotherapists to determine specific therapeutic objectives.

Short- and medium-term effect of kinesio taping or electrical stimulation in hemiplegic shoulder pain prevention: A randomized controlled pilot trial.

OBJECTIVE: To compare the short and medium-term effectiveness of combining Kinesio Tape (KT) or neuromuscular electrical stimulation (NMES) with a conventional approach to prevent shoulder pain after stroke. METHODS: Thirty-one first-time stroke survivors (58.06% females) were recruited and randomly assigned to one group; Control (n = 10), KT (n = 11), or NMES (n = 10). Ten of all participants were lost during follow-up because of death or a second stroke. The control group underwent conventional treatment (careful shoulder handling and daily mobilizations). This approach was combined with KT or NMES over deltoid muscles in the KT and NMES groups respectively. Measurements were taken at baseline, and at weeks 1, 2, 3, 4, 12, and 24 post-stroke. Data collected included self-perceived shoulder pain (Visual Analogue Scale), disability (Barthel Index and Berg scale), and upper limb function (Action Research Arm test). RESULTS: In all groups, shoulder pain did not appear during the first month (p < 0.001), but increased afterwards. In the between-groups analysis, all groups similarly improved disability and function, and no significant differences were observed for any measure (p > 0.05). CONCLUSION: The combination of KT or NMES with conventional treatment is no superior to conventional treatment alone to prevent hemiplegic shoulder pain.

Effect of Training Exercises Incorporating Mechanical Devices on Fatigue and Gait Pattern in Persons with Relapsing-Remitting Multiple Sclerosis.

Purpose: The aim of this study was to evaluate the effects of regular exercise incorporating mechanical devices on fatigue, gait pattern, mood, and quality of life in persons with relapsing-remitting multiple sclerosis (RRMS). Method: A total of 55 individuals with RRMS with an Expanded Disability Status Scale (EDSS) score of 0-4.5 and a Fatigue Severity Scale (FSS) score of 4.0 or more were randomly assigned to one of two exercise groups or a control group (n=18). Exercise programmes used aerobic, body weight, coordination, and balance exercises with either whole-body vibration (WBV; n=19; drop-outs, n=3) or the Balance Trainer system (n=18; drop-outs, n=4). Outcome measures included the FSS, Modified Fatigue Impact Scale (MFIS), Beck Depression Inventory (BDI-II), and Multiple Sclerosis International Quality of Life (MusiQoL). Spatiotemporal gait parameters were assessed using the GAITRite electronic walkway. Pre- and post-intervention assessments were performed by a blinded assessor. Intra- and inter-group analysis was performed, using the paired-samples t-test, by calculating the effect size with Cohen's d analysis and one-way analysis of variance, respectively. Results: Significant improvements in fatigue and mood were identified for both intervention groups (p<0.05). Gait parameters also improved significantly in the WBV group: velocity and step length increased (12.8% and 6.5%, respectively; p<0.005), and step time, stance time, double support time, and step length asymmetry decreased (-5.3%, -1.4%, -5.9%, and -43.7%, respectively; p<0.005). Conclusions: The results of this study support the hypothesis that combined training programmes help to reduce fatigue and improve mood in persons with mild to moderate RRMS. WBV combined with a standard exercise programme significantly improves spatiotemporal gait parameters.

Objectif : la présente étude visait à évaluer les effets de l'exercice régulier incluant des appareils mécaniques sur la fatigue, les types de démarche, l'humeur et la qualité de vie de personnes ayant une sclérose en plaques rémittente (SPR). Méthodologie : au total, 55 personnes ayant une SPR, un score de 0 à 4,5 sur l'échelle étendue des incapacités (EDSS) et un score de 4,0 ou plus sur l'échelle de gravité de la fatigue (FSS) ont été divisées au hasard entre deux groupes d'exercices et un groupe témoin (CT, n=18). Les programmes d'exercices faisaient appel à l'aérobie, au poids du corps, à la coordination et aux exercices d'équilibre à l'aide de la vibration globale du corps (groupe WBV, n=19; abandons, n=3) ou du système d'entraînement à l'équilibre (groupe BT, n=18; abandons, n=4). Les mesures de résultats incluaient la FSS, l'échelle modifiée des répercussions sur la fatigue (MFIS), l'inventaire de dépression de Beck (BDI-II) et la qualité de vie de la fédération internationale de sclérose en plaques (MusiQoL). Les chercheurs ont évalué les paramètres de démarche spatiotemporelle au moyen de la piste électronique GAITRite. Un évaluateur a procédé à des évaluations à l'aveugle avant et après les interventions. Les chercheurs ont effectué des analyses intragroupes et intergroupes à l'aide du test de Student pour échantillons appariés, en calculant la taille de l'effet par l'analyse d de Cohen et l'analyse de variance unidirectionnelle, respectivement. Résultats : les chercheurs ont constaté une diminution significative de la fatigue et une amélioration significative de l'humeur dans les deux groupes d'intervention (p<0,05). Les paramètres de démarche se sont également améliorés de manière considérable dans le groupe de WBV : la vélocité et la longueur des pas ont augmenté (12,8 % et 6,5 %, respectivement; p<0,005), tandis que la durée des pas, la durée d'appui, la durée du double appui et l'asymétrie de la longueur des pas ont diminué (−5,3 %, −1,4 %, −5,9 % et −43,7 %, respectivement; p<0,005). Conclusion : les résultats de la présente étude appuient l'hypothèse selon laquelle des programmes d'entraînement combinés contribuent à réduire la fatigue et à améliorer l'humeur des personnes présentant une SPR. La WBV combinée à un programme d'exercices standard améliore considérablement les paramètres de la démarche spatiotemporelle.