EMG Biofeedback Training to Improve Balance in Individuals With Multiple Sclerosis
NCT Number: NCT06461741
Acronym: MSBAL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Multiple Sclerosis
Interventions: DEVICE: Integrated Dual-task EMG Biofeedback Training (EMG-BF)|BEHAVIORAL: Traditional Balance Exercise Training (BAL-EX)
Sponsor: McMaster University
Collaborators: Multiple Sclerosis Society of Canada
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2027-07
Locations: McMaster University, Hamilton, Ontario, L8S4L1, Canada

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.

Primary Outcome Measures: 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 Outcome Measures: Limits of Stability (LoS), Assesses the ability of an individual to control the center of pressure (COP) on a force platform within their base of support. Subjects are instructed to move a cursor indicating their COP away from the center of their base of support in all directions using feedback provided on a computer monitor. The feedback includes a representation of the force plate and the COP which paints the area covered by its movements. The goal communicated to the subject is to create the largest coverage area possible without lifting their feet off the plate. Total and quadrant-specific areas (i.e., Total, Front Left, Front Right, Back left, and Back Right) are measured in cm2. These measures are reliable, and published reference values exist., 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), Assesses the movement of the participants center of center of pressure (COP) while standing on a force platform with hands on hips. The mean length in cm of the path traveled by the COP during the last 3 of 4 total subsequent 20s trials (one practice trial) is the outcome of interest. The test is repeated with eyes open, and eyes closed. This assessment is valid and reliable., 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), Participants start at a line on the floor and are instructed to "walk as quickly as possible but safely" beyond the second line 25 feet away. The time is recorded in seconds beginning with the first heel strike beyond the start line and ending with the first heel strike after the second line, two trials are performed with the faster time used for the analysis. This assessment is valid and reliable., 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, A patient-reported questionnaire regarding balance confidence during 16 everyday activities. The ABC scale is quick and easy to administer and has demonstrated good reliability, validity, and sensitivity in MS populations., 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), A 12-item questionnaire regarding the effect of the respondent's "condition" on their walking in the last two weeks. The questions are adapted from the MS walking scale, which is a valid and reliable measurement tool., 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), A popular health-related quality of life measure with 36 items, 8 scales, and physical and mental summary measures. The scales are physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), role-emotional (RE), social functioning (SF) and mental health (MH). The summary scores are the physical health composite summary (PCS) and the mental health composite summary (MCS). The SF-36 is valid and reliable., 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, Fall diaries are a simple and effective means to measure falls. Each participant with record falls and near-falls in a calendar by marking "F" or "NF" on the day of a fall. For each fall, participants fill a short form providing information about the cause, any injuries, or hospitalization as the result of the fall., Participant will keep the fall diary from 2 weeks before the first training session to the end of the study, 20 weeks later.
Other Outcome Measures: Visual Analog Scales (VAS), At the end of every session participants make a vertical mark on a 10-centimeter horizontal line representing a continuum between "Strongly Disagree" (0 cm) and "Strongly Agree" (10 cm). The midpoint of the line (5 cm) represents "Neither Agree nor Disagree". VAS measurements are accurate and precise. Participants will respond to VAS scales with the following prompts:

* I enjoyed the training.
* The training was challenging.
* I put forth a great deal of effort.

The average of VAS values provided in each week (3 sessions per week) of participation, and across the entire 6 weeks of training (18 sessions) will be assessed., 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), Participants will respond to 5 statements adapted from a usability questionnaire developed by Ona and colleagues. For each question, responses are provided on a 10-point scale whereby 1 represents 'strongly disagree' and 10 is 'strongly agree'. The response to each statement is summed for a total of out 50.

Statements will include:

1. The training meets a real need.
2. The training is intuitive and easy to understand.
3. I will continue to use the access the training in the future if it is available.
4. The difficulty of the training was adequate.
5. The training sessions were enjoyable., 6 weeks of training.