Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 65 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Multiple Sclerosis, Mobility Limitation, Balance; Distorted, Gait

Being tested

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

Keywords

balance, neuromodulation, neuroplasticity, multiple sclerosis, mobility

Medical subject headings

Multiple Sclerosis, Mobility Limitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 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.

• 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 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: -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)

2. 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.

   Measured: -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)

3. 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

   Measured: -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)

4. 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.

   Measured: -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)

5. 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.

   Measured: -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)

6. 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

   Measured: -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)

7. 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).

   Measured: -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)

8. 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)

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

9. 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.

   Measured: - 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted16 Sep 2025
2. Study start30 Dec 2025
3. Primary completion30 Sep 2028 (estimated)
4. Study completion30 Dec 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Multiple SclerosisStudies of the same condition, open and under way.
• More trials run by University Health Network, TorontoThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.