Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis

NCT07174973 | Recruiting

• 1 other identifier: 1431505
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

balance; neuromodulation; neuroplasticity; multiple sclerosis; mobility

Outcome Measures

Primary Outcomes (9)

• Timed Up and Go (TUG)

  Participants begin seated in a standard chair with their back against the chairrest and arms on the armrests. On the command "go," they stand up, walk 3 meters at a comfortable and safe pace, turn around, return to the chair, and sit down. The time to complete the task is recorded in seconds, with shorter times indicating better mobility. For the dual-task cognitive TUG, participants perform the same procedure while simultaneously completing a cognitive task (counting backward by threes). The score is the time in seconds to complete the task, with shorter times indicating better mobility.

  -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)

  The Timed 25-Foot Walk Test (T25FWT) is a standardized clinical measure of walking speed. Participants are instructed to walk a distance of 25 feet at their usual comfortable pace. Timing is recorded over the middle 6 meters to minimize the effects of acceleration and deceleration, with 2-meter lead-in and 2-meter lead-out zones. The test is performed twice, and the average walking speed (m/s) is calculated, with higher speeds indicating better mobility.

  -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):

  BBS is a 14-item clinical assessment of static and dynamic balance. Each item evaluates performance on a functional task such as standing unsupported, reaching forward, turning, or standing on one leg. Tasks are scored on a 5-point ordinal scale ranging from 0 (unable to perform) to 4 (independent performance), with a maximum total score of 56. Higher scores indicate better balance

  -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

  For the static balance test, participants will stand for 100 seconds on a force plate under two conditions: (1) eyes open and (2) eyes closed. For the dynamic balance test, participants will stand on the force plate and lean as far as possible in the forward, backward, and sideways directions. During these tasks, body sway, postural movements will be recorded. Visual feedback of calculated body sway will be displayed on a monitor, and participants will be instructed to shift their body toward the indicated directions.

  -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)

  MSWS-12 is a self-reported questionnaire that measures the impact of Multiple Sclerosis on walking ability. It consists of 12 items in which participants rate, on a 5-point scale (from 1 = not at all to 5 = extremely), how much MS has affected various aspects of their walking during the past two weeks (e.g., walking distance, running, climbing stairs, balance while walking). Scores are summed, transformed to a 0-100 scale, and higher values indicate greater perceived walking limitation. The MSWS-12 is widely used in MS research and clinical practice and has demonstrated strong reliability and validity.

  -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)

  FES-I is a self-report questionnaire that assesses concern about falling during everyday activities. It includes 16 items rated on a 4-point scale (1 = not at all concerned to 4 = very concerned), covering a range of indoor and outdoor tasks such as getting dressed, bathing, walking on uneven surfaces, or going out sociall

  -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

  ABC Scale is a 16-item self-report questionnaire that measures an individual's confidence in maintaining balance during common daily activities. Participants rate their confidence for each activity (e.g., standing on tiptoes, walking on icy sidewalks, reaching, or using an escalator) on a scale from 0% (no confidence) to 100% (complete confidence).

  -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

  TAM-2 questionnaire is a validated self-report tool used to assess user acceptance of new technologies. It measures key domains including perceived usefulness (the extent to which the technology improves task performance), perceived ease of use (the degree to which the technology is user-friendly), attitudes toward use, and behavioral intention to use. Items are typically rated on a Likert-type scale, and higher scores indicate greater acceptance. Participants will also take part in semi-structured qualitative interviews guided by a previously developed framework based on TAM-2. The guide consists of open-ended questions and encourages participants to share their thoughts and experience regarding perceived benefits of the training program across different domains aligned with the TAM-2 framework (behavioral intention, perceived ease of use, usefulness, and usage behavior)

  -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions)

• Feasibility and Safety Outcomes

  Feasibility outcomes will include recruitment rate, retention rate, and adherence. Recruitment rate refers to the percentage of eligible participants who enrolled relative to the number screened. Retention is defined as the proportion of participants who completed all three assessment time points, and adherence is measured by how many of the 12 training sessions each participant completed.

  - 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)

Secondary Outcomes (2)

• Neurophysiological assessment:corticospinal excitability

  -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)

• Neurophysiological Measures :Spinal excitability (SMEPs)

  -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)

Study Arms (3)

Balance training only

SHAM COMPARATOR

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

Other: Balance training only

Balance training with FES

ACTIVE COMPARATOR

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

Other: Balance training with FES

Balance training wiith combined neuromodulation (TSCS+FES)

ACTIVE COMPARATOR

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

Other: Balance training wiith combined neuromodulation (TSCS+FES)

Interventions

Balance training with FES OTHER

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 with FES

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.

Balance training wiith combined neuromodulation (TSCS+FES)

Balance training only OTHER

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.

Balance training only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Direct MS Canada: collaborator

Study Sites (1)

Toronto Rehabilitation Institute-Lyndhurst Center

Toronto, Ontario, m4g3v9, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Mobility Limitation

Interventions

proto-oncogene protein c-fes-fps

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a pilot, assessor-blinded, randomized, sham-controlled trial.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: September 16, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)