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Electrical Stimulation & Visual Feedback for Stroke

N/A
Recruiting
Led By Kristin E Musselman, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
≥18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This trial aims to develop a balance intervention to reduce falls among those with neurological disease or injury. It combines electrical stimulation & visual feedback to improve standing balance & facilitate motor & functional improvements.

Who is the study for?
This trial is for adults over 18 who can stand on their own for a minute, understand English, and have moderate trunk control. It's specifically for those with non-progressive spinal cord injury/disease or stroke that happened over a year ago and are not improving naturally anymore. People with other conditions affecting walking/balance or specific contraindications like recent fractures, botulinum toxin injections, nerve damage in legs, certain medical devices implanted, cancer treatments within six months, uncontrolled epilepsy or skin issues at electrode sites cannot join.Check my eligibility
What is being tested?
The study tests an intervention called FES+VFBT designed to improve balance and prevent falls in people affected by neurological diseases or injuries like spinal cord injury/disease (SCI/D) or stroke. Participants will use a system combining functional electrical stimulation (FES) with visual feedback balance training (VFBT), standing on a force plate while responding to visual cues that help train muscle response through electrical stimulation.See study design
What are the potential side effects?
Potential side effects may include discomfort from the electrical stimulation used during FES such as skin irritation where electrodes are placed. There might also be muscle fatigue due to exercise involved in the balance training. Since this involves physical activity and rehabilitation exercises, there's always some risk of strain or injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a spinal cord injury or stroke that hasn't worsened and can still move some muscles.
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I am 18 years old or older.
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I can stand on my own for at least 60 seconds.
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I can lean forward more than 2 inches while standing.
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I don't have any conditions affecting my walking or balance besides SCI/D or stroke.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Activities-specific Balance Confidence Scale score
Change in Berg Balance Scale score
Change in dynamic standing balance
+4 more
Secondary outcome measures
Change in correct proprioception responses of the first metatarso-phalangeal and ankle joints
Change in cutaneous pressure sensation
Change of corticospinal excitability

Trial Design

1Treatment groups
Experimental Treatment
Group I: FES+VFBTExperimental Treatment1 Intervention
Functional electrical stimulation combined with visual feedback balance training

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,462 Previous Clinical Trials
483,425 Total Patients Enrolled
Kristin E Musselman, PhDPrincipal InvestigatorKITE-Toronto Rehabilitation Institute, UHN
3 Previous Clinical Trials
47 Total Patients Enrolled

Media Library

FES+VFBT (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05744271 — N/A
Spinal Cord Injury Research Study Groups: FES+VFBT
Spinal Cord Injury Clinical Trial 2023: FES+VFBT Highlights & Side Effects. Trial Name: NCT05744271 — N/A
FES+VFBT (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05744271 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this investigation still open?

"The information posted on clinicaltrials.gov indicates that this medical trial is no longer recruiting candidates, the last update being February 15th 2023. Nevertheless, there are currently 1384 other studies actively seeking participants."

Answered by AI
~9 spots leftby Dec 2024