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Home-Based FES Training for Stroke (HomeFES Trial)
N/A
Recruiting
Led By Tanvi Bhatt, PhD
Research Sponsored by University of Illinois at Chicago
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 (week 1), mid-training (week 7) and immediate post-training (week 12)
Awards & highlights
HomeFES Trial Summary
This trial will examine the feasibility, safety, & effect of home-based FES & task-specific training in adults with chronic stroke on gait, balance & mobility.
Who is the study for?
This trial is for adults aged 18-90 with chronic stroke who can walk at least 300 ft independently and use a smartphone daily. They must have had their stroke over 6 months ago, speak English, and have internet at home. Excluded are those with recent major surgery or hospitalization, severe depression, certain medical conditions like uncontrolled hypertension or epilepsy, pacemaker users, osteoporosis, cognitive impairment or other neurological conditions.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of using functional electrical stimulation (FES) at home to improve walking, balance and mobility in people with chronic stroke. Participants will receive FES devices for a 12-week training program including initial lab sessions followed by home-based exercises.See study design
What are the potential side effects?
Potential side effects may include discomfort or skin irritation where the FES device attaches to the body. There's also a risk of muscle fatigue from exercise training. The trial excludes individuals likely to experience more serious side effects.
HomeFES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (week 1), mid-training (week 7) and immediate post-training (week 12)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 1), mid-training (week 7) and immediate post-training (week 12)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Dynamic balance from baseline to mid and post-training
Change in Functional balance from baseline to mid and post-training
Change in balance confidence from baseline to mid and post-training
+24 moreHomeFES Trial Design
1Treatment groups
Experimental Treatment
Group I: Home-training with functional electrical stimulationExperimental Treatment1 Intervention
This study employs a single group pre-post design to determine the feasibility, safety and efficacy of a 12-week of home-based combined FES and task-specific training program. Also, this study will test the effect of the same intervention on gait, mobility and balance in adults with chronic stroke.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Functional Electrical Stimulation
2007
N/A
~260
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
607 Previous Clinical Trials
1,559,326 Total Patients Enrolled
18 Trials studying Stroke
2,222 Patients Enrolled for Stroke
Tanvi Bhatt, PhDPrincipal InvestigatorUniversity of Illinois at Chicago
5 Previous Clinical Trials
558 Total Patients Enrolled
2 Trials studying Stroke
110 Patients Enrolled for Stroke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You use a smartphone every day.You have trouble speaking and understanding language.You have very severe depression, as measured by a specific scale.You have a blood clot in a deep vein.You have had or currently have any kind of active cancer.You have nerve damage or weakness in the limb that is being studied.You have high blood pressure or angina that is not being well controlled.You have a skin condition that doesn't work well with FES therapy.You have a history of epilepsy or seizure disorders.You had Botox treatment in the last 5 months.You have a pacemaker.If a special test shows that your heel bone is weak, you will not be able to join the study.You have trouble with memory or thinking, scoring less than 26 out of 30 on a specific test.You have any brain condition other than a stroke.You have uncontrolled high or low blood pressure, untreated diabetes, or any serious muscle, nerve, or overall health conditions.You must be between 18 and 90 years old.This criterion checks if you have internet or Wi-Fi at your home.You have weakness on one side of your body.You weigh more than 250 pounds.You had a stroke more than 6 months ago.You can walk by yourself for at least 300 feet, with or without a walking aid.
Research Study Groups:
This trial has the following groups:- Group 1: Home-training with functional electrical stimulation
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 the age eligibility for this clinical trial limited to adults, or are minors allowed to participate as well?
"This trial is inviting participation from individuals aged 18 and above who are under 90 years old."
Answered by AI
Who is eligible to partake in this medical experiment?
"Qualified applicants must have experienced a stroke and be between 18-90 years of age in order to enroll in this trial. The medical team requires 30 participants overall."
Answered by AI
Is there additional capacity for volunteers to join this medical trial?
"Indeed, the information available on clinicaltrials.gov indicates that this trial is currently recruiting participants. The posting was initiated on December 10th 2022 and most recently updated on April 27th 2023, seeking 30 patients from one medical centre."
Answered by AI
How many volunteers are participating in this medical experiment?
"Affirmative. Online records highlight that this clinical trial is still open to recruitment, having been first posted on December 10th 2022 and recently updated on April 27th 2023. It requires 30 participants across a single site."
Answered by AI
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