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Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis
NCT07174973 · University Health Network, Toronto
In plain English
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Official title
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
About this study
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
Eligibility criteria
Participants will be eligible if they meet the following conditions:
* Confirmed diagnosis of Multiple Sclerosis (MS) according to the revised McDonald criteria
* Age ≤ 65 years
* Ability to walk at least 100 meters, with or without an assistive device, and without requiring rest
* Self-reported perception of impaired balance during standing or walking in daily activities
Exclusion Criteria:
* 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 measures
* 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 site, pregnancy, active deep vein thrombosis
Study design
Enrollment target: 24 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-12-30
Estimated completion: 2028-12-30
Last updated: 2026-03-16
Interventions
Other: Balance training with FESOther: Balance training wiith combined neuromodulation (TSCS+FES)Other: Balance training only
Primary outcomes
- • Timed Up and Go (TUG) (-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))
- • Timed 25 feet walk test (T25FWT) (-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): (-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))
Sponsor
University Health Network, Toronto · other
With: Direct MS Canada
All locations (1)
Toronto Rehabilitation Institute-Lyndhurst CenterRecruiting
Toronto, Ontario, Canada