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NCT Number: NCT06461741

EMG Biofeedback Training to Improve Balance in Individuals with Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S4L1, Canada

Location status: Recruiting

Location contact

Aimee Nelson, PhD

CONTACT

[email protected]

9055259140 ext. 28053

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Mini-Balance Evaluation Systems Test (Mini-BESTest)

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

    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").

Secondary outcomes

  1. Limits of Stability (LoS)

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

    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.

  2. Sway in Quiet Stance (QS)

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

    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.

  3. Timed 25ft Walk Test (T25WT)

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

    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.

  4. Activities-specific Balance Confidence (ABC) scale

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

    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.

  5. 12-item Subjective Walking Scale (SWS-12)

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

    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.

  6. Short-Form 36 Health Survey (SF-36)

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

    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.

  7. Fall and Near-Fall Frequency

    Time frame: Participant will keep the fall diary from 2 weeks before the first training session to the end of the study, 20 weeks later.

    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.

Other outcomes

  1. Visual Analog Scales (VAS)

    Time frame: 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.

    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.

  2. Enjoyment Scale (ES)

    Time frame: 6 weeks of training.

    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:

    • The training meets a real need.
    • The training is intuitive and easy to understand.
    • I will continue to use the access the training in the future if it is available.
    • The difficulty of the training was adequate.
    • The training sessions were enjoyable.

Study contacts

Contact information is provided by the study sponsor or research team.

Aimee J Nelson, PhD

CONTACT

[email protected]

905 525 9140 ext. 28053

Stephen L Toepp, PhD

CONTACT

[email protected]

2896964538

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Multiple Sclerosis Society of Canada

Registry information

Official study title

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

Acronym: MSBAL

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 17, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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