EMG Biofeedback Training to Improve Balance in Individuals with Multiple Sclerosis

NCT06461741 | Recruiting

• 1 other identifier: MS Balance Study
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Balance; Falls

Outcome Measures

Primary Outcomes (1)

• Mini-Balance Evaluation Systems Test (Mini-BESTest)

  A sensitive, reliable, and valid 14-item scale that assesses dynamic balance. It includes components evaluating anticipatory postural adjustments, responses to perturbation, sensory orientation, and dynamic stability during gait. The total score ranges from 0 ("no balance") to 28 ("complete balance").

  It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)

Secondary Outcomes (7)

• Limits of Stability (LoS)

  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)

  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)

  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

  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)

  It will be measured at baseline, 6 weeks of training, and 3 months after the end of training (18 weeks from baseline)

Other Outcomes (2)

• Visual Analog Scales (VAS)

  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.

• Enjoyment Scale (ES)

  6 weeks of training.

Study Arms (2)

Integrated Dual-task EMG Biofeedback Training (EMG-BF)

EXPERIMENTAL

Participants will engage in EMG-BF for 30 minutes 3 times per week for 6 weeks for a total of 18 sessions. Our novel EMG Biofeedback training system can be adapted to a training objective by planning 3 to 5 movements and placing sensors over muscles that must be active when the user adheres to the correct movement form. For our training we use right or left torso shift with knee bend, and right or left hand opening, and place sensors over left and right vastus lateralis and left and right extensor digitorum superficialis muscles. Each movement corresponds to a specific videogame command. To introduce cognitive challenge, we randomly shuffle the game command assigned to each movement at the beginning of every session. This will require the user to choose the appropriate movement to trigger the intended game input while suppressing incorrect movements. We use the puzzle game, Tetris, which requires spatial reasoning and planning under increasingly tight time constraints.

Device: Integrated Dual-task EMG Biofeedback Training (EMG-BF)

Traditional Balance Exercise Training (BAL-EX)

ACTIVE COMPARATOR

Participants will perform 7 balance exercises traditionally prescribed by physiotherapists. The first is a heel/toe square exercise where the trainee lifts their right toe and left heel, then their left toe and right heel, then both heels, then both toes. The 2nd exercise involves maintaining tandem stance while static, then moving the arms, then looking up and down, then looking left and right. The 3rd exercise is lateral stepping where the individual steps with one foot out to the side and then bring the foot back to the starting stance. The 4th exercise is a golfer's lift where the person slowly leans forward while extending one leg straight behind and touches the seat of a chair placed opposite. The 5th exercise is extended-duration single leg stands and exercises 6 and 7 are back and side leg raises, respectively. The exercise sequence will repeat until 30 minutes has expired. Sessions are repeated 3 times per week for 6 weeks, for 18 sessions.

Behavioral: Traditional Balance Exercise Training (BAL-EX)

Interventions

Integrated Dual-task EMG Biofeedback Training (EMG-BF) DEVICE

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 amplifier can be used. The effect of the "device" is therefore primarily defined by the software. An in-depth description of the software and hardware systems is published in the cites study, "An EMG-Based Biofeedback System for Tailored Interventions Involving Distributed Muscles". In this trail is the Explore+ ExG amplifier which is sold by Mentalab.

Integrated Dual-task EMG Biofeedback Training (EMG-BF)

Traditional Balance Exercise Training (BAL-EX) BEHAVIORAL

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.

Traditional Balance Exercise Training (BAL-EX)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Multiple Sclerosis Society of Canada: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S4L1, Canada

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

Related Links

• Link to the above cited work, which describes the EMG Biofeedback approach used in this trial.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Aimee J Nelson, PhD

CONTACT

905 525 9140; nelsonaj@mcmaster.ca

Stephen L Toepp, PhD

CONTACT

2896964538; toeppsl@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 17, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)