EMG Biofeedback Training to Improve Balance in Individuals with Multiple Sclerosis

Официальное название

Integrated Dual-task EMG Biofeedback Balance Training to Improve Balance in Individuals Living with Multiple Sclerosis

Обзор

The goal of this clinical trial is to test the impact of a novel dual-task EMG Biofeedback training method for improving balance in individuals living with multiple sclerosis. The main question\[s\] it aims to answer are: * Does dual-task EMG biofeedback training deliver lasting balance benefits up to 3 months following the intervention? * Are the benefits greater than those for participation in traditional balance training exercises? * Do the benefits vary with the severity of disability? Participants will receive either EMG Biofeedback (EMG-BF) training or traditional balance exercise (BAL-EX) training. Both treatments involve three 30-minute sessions of the training every week for 6 weeks (18 sessions). During the sessions, participants in the EMG-BF treatment group will perform targeted exercises using feedback from adhesive (sticker) sensors on their arms and legs. Participants in the BAL-EX treatment group will following an instructor through balance training movements that are traditionally prescribed by physiotherapists to improve balance. Measurements will be taken at the beginning of the study, after six weeks of training, and three months after the end of training. Researchers will compare the groups to see if balance and related outcomes are improved more by 6-weeks of EMG-BF training than BAL-EX.

Вмешательства

• Устройство Integrated Dual-task EMG Biofeedback Training (EMG-BF)
  The intervention is an exercise training that is facilitated by feedback derived from electrical muscle activity measured through electromyography (EMG). An EMG Biofeedback software uses a machine learning algorithm to identify the desired movements and reinforce them by displaying feedback on a computer monitor in the form of videogame control. The EMG acquisition hardware must have at least 4 sensor channels and a sampling rate of \>1KHz. Other than these specifications, any generic EMG amplif
• Поведенческое Traditional Balance Exercise Training (BAL-EX)
  This intervention is a time-matched active comparator for the EMG-BF intervention. A sequence of seven traditional, balance exercises, taking 1-3 minutes each, is repeated for a total of 30 minutes on each of 18 sessions in the 6-week intervention period. The exercises are ones that challenge the coordination and strength of postural muscles in the presence of various vestibular stimuli. The specific exercises are described in the Arm description.

Первичные конечные точки

• Mini-Balance Evaluation Systems Test (Mini-BESTest) [Срок оценки: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)]

Вторичные конечные точки (7)

• Limits of Stability (LoS) [Срок оценки: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)]
• Sway in Quiet Stance (QS) [Срок оценки: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)]
• Timed 25ft Walk Test (T25WT) [Срок оценки: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)]
• Activities-specific Balance Confidence (ABC) scale [Срок оценки: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)]
• 12-item Subjective Walking Scale (SWS-12) [Срок оценки: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)]
• Short-Form 36 Health Survey (SF-36) [Срок оценки: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)]
• Fall and Near-Fall Frequency [Срок оценки: Participant will keep the fall diary from 2 weeks before the first training session to the end of the study, 20 weeks later.]

Критерии участия

Критерии включения

• Adults aged 18-80 years with a formal diagnosis of MS.
• Participants must be ambulatory and report problems with walking and/or balance.
• Have stable disease with no relapses in the last 3 months.
• Agreement to not introduce or change the dosage of pharmaceutical treatments during the study period. This includes intramuscular injections (e.g., Botox), intravenous, and orally administered drugs.
• Agreement to maintain the frequency, duration and intensity of physical therapy or any alternate therapies (e.g., massage, osteopathic, chiropractic, etc.) for the duration of the trial.

Критерии исключения

• Unable to follow instructions due to cognitive deficit or language barrier
• Presence of visual disorders that prevent meaningful interaction with the intervention interface.
• Unable to maintain stable pharmaceutical treatment for the duration of the study.
• Unable to maintain the frequency, duration and intensity of physical therapy or alternate therapies outside of the trial for the duration of the trial.
• Received Botox treatment within 3 months of the onset of the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• McMaster University — Hamilton

Публикации

• Toepp SL, Mohrenschildt MV, and Nelson AJ. An EMG-Based Biofeedback System for Tailored Interventions Involving Distributed Muscles. IEEE Sensors Journal. 2024; 23(22): 28095-28109.

Идентификаторы

NCT: NCT06461741 · MS Balance Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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