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.

Evaluation of More Stamina, a Mobile App for Fatigue Management in Persons with Multiple Sclerosis: Protocol for a Feasibility, Acceptability, and Usability Study.

BACKGROUND: Multiple sclerosis (MS) is one of the world's most common neurologic disorders leading to severe disability in young adults. MS-related fatigue directly impacts on the quality of life and activity levels of people with MS. Self-management strategies are used to support them in the care of their health. Mobile health (mHealth) solutions can offer tools to help symptom management. Following a user-centered design and evidence-based process, an mHealth solution called More Stamina was created to help persons with MS manage their fatigue. OBJECTIVE: The overall study aims are to explore the feasibility, acceptability, and usability of More Stamina, a mobile app for fatigue self-management for persons with MS. METHODS: A mixed-methods, multicenter study will be used to assess the feasibility, acceptability, and usability of More Stamina. The study will take place during the third and fourth quarters of 2020 (Q3-Q4 2020) in 3 locations: Argentina, Spain, and Switzerland. A longitudinal cohort study will take place, and think-aloud protocols, open-ended interviews, and short answer questionnaires will be used. Persons with MS will be recruited from the different locations. This study seeks to enroll at least 20 patients that meet the criteria from each site for the longitudinal cohort study (total n=60). RESULTS: Ethical approval has been granted in Argentina and is pending in Spain and Switzerland. Outcomes will be published in peer-reviewed medical journals and presented at international conferences. CONCLUSIONS: Findings from this study will be used to help understand the role that mHealth can play in fatigue management in MS. TRIAL REGISTRATION: ClinicalTrials.gov NCT04244214; https://clinicaltrials.gov/ct2/show/NCT04244214. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/18196.

Effectiveness of Dry Needling versus Placebo on Gait Performance, Spasticity, Electromyographic Activity, Pain, Range-of-Movement and Quality of Life in Patients with Multiple Sclerosis: A Randomized Controlled Trial Protocol.

Dry needling (DN) is an emerging technique commonly used in neurological and musculoskeletal pain conditions, but there have been no previous studies in patients with multiple sclerosis (pwMS). This trial aims to assess the efficacy of deep DN, compared with sham placebo DN, on gait performance, spasticity level, pain, electromyographic activity, range-of-movement (ROM) and quality of life in pwMS. Forty adults with MS were randomly assigned to one study group. The DN group will undergo 2 sessions (once per week) using DN over the rectus femoris (RF) and gastrocnemius medialis (GM) muscles at the lower extremity with higher spasticity. The placebo group will receive the same protocol using a sham placebo needle (Dong Bang needle). Outcome measures will include gait performance, using the GaitRite® system, spasticity level with the Modified Ashworth Scale, superficial electromyographic activity of RF and GM, pain (pressure algometer), ROM (goniometer), and quality of life (Musiqol). This study is the first investigating the short-term effect of DN, compared with placebo, in pwMS, and taking into account the possible changes in the electromyographic activity of the lower limb. Therefore, the results may help to understand the suitability of using this technique in the clinical setting for this population. Trial registration: ACTRN12619000880145.

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.