Testing Balance training with FES against a placebo for multiple sclerosis
Official title: Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis
Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis: Evaluating the Combined Effects of Transcutaneous Spinal Cord Stimulation, Functional Electrical Stimulation, and Visual Feedback Balance Training
Interventions
Balance training with FES
Participants assigned to this group complete a standardized balance training program while receiving FES to the lower limb muscles. Training sessions involve standing in a safety harness and performing interactive, game-based balance tasks on a force plate that provides real-time visual feedback of body sway. FES will be applied bilaterally to specific leg muscles (e.g., tibialis anterior, quadriceps, gastrocnemius) using surface electrodes. Stimulation parameters (pulse width, frequency, and amplitude) are individually adjusted to produce visible yet comfortable muscle contractions that support functional standing and balance activities. Stimulation is delivered in synchrony with balance exercises to augment muscle activation during postural adjustments.
Balance training wiith combined neuromodulation (TSCS+FES)
Participants in this group complete the standardized balance training program while receiving both FES and TSCS. Training sessions take place in a safety harness and involve interactive, game-based balance exercises performed on a force plate with real-time visual feedback of body sway.FES is delivered bilaterally to lower limb muscles (e.g., tibialis anterior, quadriceps, gastrocnemius) through surface electrodes. Stimulation parameters (pulse width, frequency, amplitude) are individualized to produce visible, comfortable contractions that facilitate muscle activation during postural tasks.TSCS is applied simultaneously via electrodes placed over the thoracolumbar spinal region to modulate spinal excitability and enhance neuromuscular control. Standardized stimulation parameters are used across participants, with adjustments made to ensure tolerance and safety.
Balance training only
Participants in this group complete the standardized balance training program without electrical stimulation. Sessions are conducted in a safety harness and consist of interactive, game-based balance exercises performed on a force plate, which provides real-time visual feedback of body sway. Tasks are designed to challenge postural control by requiring weight shifting in multiple directions, maintaining stability during perturbations, and progressively increasing task difficulty.
Canadian Sites (1)
Toronto Rehabilitation Institute-Lyndhurst Center
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for9 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Exclusion
- −Participants will be excluded if they present with any of the following:
- −Uncorrected visual problems
- −Cognitive impairment affecting comprehension of instructions or completion of self-administered outcome measuresEndpointThe specific thing a study measures to answer its question.Read more →
- −Ongoing MS exacerbation or paroxysmal vertigo
- −Concurrent neurological or orthopedic conditions affecting balance
- −Recent participation in rehabilitation therapies (physical therapy, occupational therapy, or vestibular therapy) within one month prior to recruitment
- −Planned or recent injection of botulinum toxin to the legs during the intervention period
- −Peripheral nerve damage affecting the legs
- −Contraindications to electrical stimulation, including:implanted electronic device, active cancer or radiation treatment within the past 6 months, uncontrolled epilepsy, skin rash or open wound at electrode siteTrial siteA hospital or clinic where a study is actually run.Read more →, pregnancy, active deep vein thrombosis
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Balance training with FES, Balance training wiith combined neuromodulation (TSCS+FES), Balance training only.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a sham procedureSham procedureA procedure made to feel like the real one, without the active step.Read more → — one made to feel like the real thing but without the active step.
One group receives an existing treatment, so the two can be compared.
There are 3 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 65 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 24 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: -BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → (Week 8 post-intervention, approximately Week 14 from baseline).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Timed Up and Go (TUG) — measured over -BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → (Week 8 post-intervention, approximately Week 14 from baseline).
Timed 25 feet walk test (T25FWT) — measured over -Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline).
Berg Balance Scale (BBS): — measured over -Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline).
Static & Dynamic balance tests — measured over -Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline).
The study lists 5 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07174973 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Balance training with FESOther
Participants assigned to this group complete a standardized balance training program while receiving FES to the lower limb muscles. Training sessions involve standing in a safety harness and performing interactive, game-based balance tasks on a force plate that provides real-time visual feedback of body sway. FES will be applied bilaterally to specific leg muscles (e.g., tibialis anterior, quadriceps, gastrocnemius) using surface electrodes. Stimulation parameters (pulse width, frequency, and amplitude) are individually adjusted to produce visible yet comfortable muscle contractions that support functional standing and balance activities. Stimulation is delivered in synchrony with balance exercises to augment muscle activation during postural adjustments.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Balance training wiith combined neuromodulation (TSCS+FES)Other
Participants in this group complete the standardized balance training program while receiving both FES and TSCS. Training sessions take place in a safety harness and involve interactive, game-based balance exercises performed on a force plate with real-time visual feedback of body sway.FES is delivered bilaterally to lower limb muscles (e.g., tibialis anterior, quadriceps, gastrocnemius) through surface electrodes. Stimulation parameters (pulse width, frequency, amplitude) are individualized to produce visible, comfortable contractions that facilitate muscle activation during postural tasks.TSCS is applied simultaneously via electrodes placed over the thoracolumbar spinal region to modulate spinal excitability and enhance neuromuscular control. Standardized stimulation parameters are used across participants, with adjustments made to ensure tolerance and safety.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Balance training onlyOther
Participants in this group complete the standardized balance training program without electrical stimulation. Sessions are conducted in a safety harness and consist of interactive, game-based balance exercises performed on a force plate, which provides real-time visual feedback of body sway. Tasks are designed to challenge postural control by requiring weight shifting in multiple directions, maintaining stability during perturbations, and progressively increasing task difficulty.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study includes a shamSham procedureA procedure made to feel like the real one, without the active step.Read more → comparison — a procedure made to feel like the real one, without the active step.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 65 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: -BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → (Week 8 post-intervention, approximately Week 14 from baseline).
The study as a whole is currently expected to finish around 2028-12-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 24 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study will evaluate the effects of combining balance training with electrical stimulation techniques in individuals with Multiple Sclerosis (MS). MS commonly impairs leg strength, coordination, and balance, increasing the risk of falls and reducing independence. The interventions include:Balance training only, Balance training with Functional Electrical Stimulation (FES), and Balance training with FES and Transcutaneous Spinal Cord Stimulation (TSCS). FES delivers small electrical pulses to leg muscles, while TSCS delivers electrical signals through the skin to stimulate the spinal cord and enhance motor control. The study will enroll up to 24 participants over a 3-year period. This trial is funded by MS Canada. Participants will be randomly assigned to one of three groups: (1) balance training only, (2) balance training with FES, or (3) balance training with FES and TSCS. All participants will complete 12 supervised training sessions over 6 weeks. During each session, participants will engage in interactive balance games while standing in a safety harness.Outcome assessments will be conducted at three time points: baseline (prior to training), post-intervention (after 6 weeks), and follow-up (8 weeks after training). Assessments will include: * Clinical tests of mobility and balance (Timed Up and Go:TUG, 10-Meter Walk Test:10MWT, Berg Balance Scale:BBS) * Computerized balance testing using a force plate * Questionnaires on walking ability, fear of falling, and balance confidence * Neurophysiological measures of brain-spinal cord-muscle communication before and after training
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.