Recruiting

Balance Training, FES, TSCS

Sponsor:

University Health Network, Toronto

Code:

NCT07174973

Conditions

Multiple Sclerosis

Mobility Limitation

Balance; Distorted

Gait

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Balance training with FES

Balance training wiith combined neuromodulation (TSCS+FES)

Balance training only

Study Details

Brief summary:

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

Conditions

Multiple Sclerosis

Mobility Limitation

Balance; Distorted

Gait

Study ID

NCT07174973

Start date

Dec 30, 2025

Status verified date

Mar, 2026

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Balance training only

Participants in this group complete the standardized balance training program with sham electrical stimulation.

active comparator: Balance training with FES

This group will receive active FES+ sham TSCS (FES only group) duing balance training

active comparator: Balance training wiith combined neuromodulation (TSCS+FES)

This group will receive both TSCS \& FES (combined neuromodulation) during 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.

Primary outcome measure

  • Timed Up and Go (TUG) [ Time Frame: -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) [ Time Frame: -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): [ Time Frame: -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 [ Time Frame: -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) ]
  • MS Walking Scale-12 (MSWS-12) [ Time Frame: -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) ]
  • Falls Efficacy Scale-International (FES-I) [ Time Frame: -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) ]
  • Activities-Specific Balance Confidence (ABC) Scale [ Time Frame: -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) ]
  • Acceptability Outcomes [ Time Frame: -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) ]
  • Feasibility and Safety Outcomes [ Time Frame: - All adverse events will bereported throughout the study period - Feasibility metrics at Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) and Follow-up (Week 8 post-intervention, approximately Week 14 from baseline) ]

Central Contacts and Locations

Locations

Toronto Rehabilitation Institute-Lyndhurst Center

Recruiting

Toronto, Ontario, Canada, m4g3v9

Contacts

Kei Masani, PhD

416-597-3422k.masani@utoronto.ca

Shirin Tajalli, PhD

6474108068shirin.tajalli@utoronto.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • balance
  • neuromodulation
  • neuroplasticity
  • multiple sclerosis
  • mobility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-16.