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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
Be older than 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.
Timeline
Screening ~ 3 weeks3 visits
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
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
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 moreSecondary 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
1,478 Previous Clinical Trials
485,380 Total Patients Enrolled
Kristin E Musselman, PhDPrincipal InvestigatorKITE-Toronto Rehabilitation Institute, UHN
3 Previous Clinical Trials
46 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a history of epilepsy or seizures.I have had a fracture in my leg due to weak bones.I have not had a botulinum toxin injection in my legs in the last two weeks and do not plan to during treatment.I have nerve damage in my legs.I don't have an implanted device, active cancer, recent radiation, uncontrolled epilepsy, skin issues at electrode sites, am not pregnant, and don't have active deep vein thrombosis.I have a spinal cord injury or stroke that hasn't worsened and can still move some muscles.It's been over a year since my spinal cord injury/stroke, and my recovery has plateaued.I am 18 years old or older.I can stand on my own for at least 60 seconds.I can lean forward more than 2 inches while standing.I don't have any conditions affecting my walking or balance besides SCI/D or stroke.
Research Study Groups:
This trial has the following groups:- Group 1: FES+VFBT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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