Multiple SclerosisMSBALNCT06461741
EMG Biofeedback Training to Improve Balance in Individuals with Multiple Sclerosis
A study testing Integrated Dual-task EMG Biofeedback Training (EMG-BF) and Traditional Balance Exercise Training (BAL-EX) in people with Multiple Sclerosis, run by McMaster University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Integrated Dual-task EMG Biofeedback Training (EMG-BF) and Traditional Balance Exercise Training (BAL-EX)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University
Hamilton, Ontario, L8S4L1
Aimee Nelson, PhD, 9055259140 ext. 28053, nelsonaj@mcmaster.ca
About this study
Official title: Integrated Dual-task EMG Biofeedback Balance Training to Improve Balance in Individuals Living 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?
Read more
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
- Being tested
- Integrated Dual-task EMG Biofeedback Training (EMG-BF), Traditional Balance Exercise Training (BAL-EX)
- Keywords
- Balance, Falls
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional Balance Exercise Training (BAL-EX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Participant will keep the fall diary from 2 weeks before the first training session to the end of the study, 20 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Oct 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada
- Responsible party
- Principal investigator, Aimee Nelson, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461741
- Sponsor's protocol ID
- MS Balance Study
- Acronym
- MSBAL
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Dual-task EMG Biofeedback Balance Training to Improve Balance in Individuals Living with Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06461741
- Acronym / sponsor ID
- MSBAL / MS Balance Study
- Conditions
- Multiple Sclerosis
- Keywords
- Balance, Falls
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Dual-task EMG Biofeedback Training (EMG-BF) | Experimental | Device: Integrated Dual-task EMG Biofeedback Training (EMG-BF)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. |
| Traditional Balance Exercise Training (BAL-EX) | Active comparator | Behavioral: Traditional Balance Exercise Training (BAL-EX)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Device | Integrated Dual-task EMG Biofeedback Training (EMG-BF) |
| 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. | Behavioural | Traditional Balance Exercise Training (BAL-EX) |
Primary outcome
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").
7 secondary outcomes
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)
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)
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)
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)
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)
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- BackgroundToepp 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.
- Link to the above cited work, which describes the EMG Biofeedback approach used in this trial.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Dual-task EMG Biofeedback Training (EMG-BF) and Traditional Balance Exercise Training (BAL-EX) in people with Multiple Sclerosis, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aimee J Nelson, PhD (905 525 9140 ext. 28053, nelsonaj@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06461741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.