Clinical trial NCT06461741: EMG Biofeedback Training to Improve Balance in Individuals with Multiple Sclerosis
Official title: Integrated Dual-task EMG Biofeedback Balance Training to Improve Balance in Individuals Living with Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Balance
Falls
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Multiple Sclerosis Society of Canada
First posted: 2024-06-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mini-Balance Evaluation Systems Test (Mini-BESTest)
timeFrame: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)
Secondary outcomes:
measure: Limits of Stability (LoS)
timeFrame: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)
measure: Sway in Quiet Stance (QS)
timeFrame: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)
measure: Timed 25ft Walk Test (T25WT)
timeFrame: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)
measure: Activities-specific Balance Confidence (ABC) scale
timeFrame: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)
measure: 12-item Subjective Walking Scale (SWS-12)
timeFrame: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)
measure: Short-Form 36 Health Survey (SF-36)
timeFrame: It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)
measure: Fall and Near-Fall Frequency
timeFrame: Participant will keep the fall diary from 2 weeks before the first training session to the end of the study, 20 weeks later.
Other outcomes:
measure: Visual Analog Scales (VAS)
timeFrame: The weekly 3-session average will be assessed for week 1, 2, 3, 4, 5 and 6. the average across all six weeks (18 sessions) will be assessed.
measure: Enjoyment Scale (ES)
timeFrame: 6 weeks of training.
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References:
citation: 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.