CompletedNot Applicable

Evaluation of FES+VFBT With Individuals With Lived Experience

Canada18 participantsStarted 2023-04-01

Plain-language summary

Falls are a concern for people living with spinal cord injury (SCI) or stroke. Falls may result in injury and a fear of falling, which often cause people to restrict their mobility and daily activities. Despite its importance, fall prevention for people with SCI or stroke has not been studied in detail, and as a result, there is a lack of treatments to address their high fall risk. Functional electrical stimulation (FES) is the application of a mild electrical stimulus to a muscle that helps it move better. In this study, the MyndSearch device will be used to deliver FES. The visual feedback balance training (VFBT) is similar to playing a video game on a balance board while following visual cues on a screen. The purpose of this study is to evaluate an intervention that combines FES and VFBT to improve balance and lead to the recovery of safe mobility in individuals living with neurological disease or injury (e.g., spinal cord injury, stroke).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Individuals with a non-progressive, motor incomplete SCI/D (i.e. American Spinal Injury Association Impairment Scale (AIS) C or D) or a middle cerebral artery (MCA) stroke
✓. chronic stage of recovery (i.e. \>1 year post-SCI/D or stroke), when natural recovery has plateaued
✓. ≥18 years old
✓. able to stand independently for 60 seconds
✓. moderate level of trunk control as evidenced by the ability to reach forward \>2 inches in standing (i.e. score of 1-3 on the Berg Balance Scale Reaching Forward task);
✓. free of any other condition besides SCI/D or stroke that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss)
✓. able to understand spoken English

Exclusion criteria

✕. a prior lower extremity fragility fracture
✕. an injection of botulinum toxin to leg muscles in the past two weeks or injection planned during treatment period

What they're measuring

Change in Berg Balance Scale score

Timeframe: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention

Change in Activities-specific Balance Confidence Scale score

Timeframe: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention

Change in strength of the trunk and lower extremity

Timeframe: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention

Change in static standing balance

Timeframe: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention

Change in dynamic standing balance

Timeframe: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention

Questionnaire on the participants' perspectives of the FES+VFBT intervention

Timeframe: Immediately after the intervention

Trial details

NCT IDNCT05744271

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-22

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Individuals with a non-progressive, motor incomplete SCI/D (i.e. American Spinal Injury Association Impairment Scale (AIS) C or D) or a middle cerebral artery (MCA) stroke
✓. chronic stage of recovery (i.e. \>1 year post-SCI/D or stroke), when natural recovery has plateaued
✓. ≥18 years old
✓. able to stand independently for 60 seconds
✓. moderate level of trunk control as evidenced by the ability to reach forward \>2 inches in standing (i.e. score of 1-3 on the Berg Balance Scale Reaching Forward task);
✓. free of any other condition besides SCI/D or stroke that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss)
✓. able to understand spoken English

Exclusion criteria

✕. a prior lower extremity fragility fracture
✕. an injection of botulinum toxin to leg muscles in the past two weeks or injection planned during treatment period

What they're measuring

Change in Berg Balance Scale score

Timeframe: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention

Change in Activities-specific Balance Confidence Scale score

Timeframe: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention

Change in strength of the trunk and lower extremity

Timeframe: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention

Change in static standing balance

Timeframe: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention

Change in dynamic standing balance

Timeframe: Baseline, after three weeks of the intervention, immediately after the intervention, 6-week follow-up after the intervention, 12-week follow-up after the intervention

Questionnaire on the participants' perspectives of the FES+VFBT intervention

Timeframe: Immediately after the intervention