Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Health Network, Toronto

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Balance training with FES
  • Balance training wiith combined neuromodulation (TSCS+FES)
  • Balance training only

Treatment groups

24 Participants
are divided into 3 treatment groups

Sponsors and collaborators