BridgeMD
New treatment option for Chronic Stroke
Official title Home-based FES Training in People With Chronic Stroke
ClinicalTrials.gov ID: NCT05849532
What this study is testing
- What it's testing
- This project will examine the feasibility, safety and effect of home-based functional electrical stimulation (FES) applied to different lower limb muscles in combination with task-specific training on gait, balance and mobility in adults with chronic stroke. 30 individuals with chronic stroke will first undergo initial screening and baseline walking, mobility, balance and strength assessments in the laboratory.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Age group: 18-90 years.
- Presence of unilateral hemiparesis.
- Onset of stroke (\> 6 months).
- Ability to walk independently with or without an assistive device for at least 300 ft.
- Can understand and communicate in English and can verbalize discomfort or pain in English
You likely can't join if
- Body weight more than 250 lbs.
- Heel bone density measurement using an ultrasound device. Individuals classified as osteoporotic (i.e., with a T-score \< -2) will be excluded.
- Cognitive impairment (Montreal Cognitive assessment score \<26/30)
- Verbal Aphasia (i.e \<71% score on Mississippi Aphasia Screening)
- Severe depression (\> 15 points on geriatric depression scale)
- Any neurological condition other than stroke.
See the full eligibility criteria
- Age group: 18-90 years.
- Presence of unilateral hemiparesis.
- Onset of stroke (\> 6 months).
- Ability to walk independently with or without an assistive device for at least 300 ft.
- Can understand and communicate in English and can verbalize discomfort or pain in English
- Use of smartphone on a daily basis
- Availability of internet/Wi-Fi at home
- Body weight more than 250 lbs.
- Heel bone density measurement using an ultrasound device. Individuals classified as osteoporotic (i.e., with a T-score \< -2) will be excluded.
- Cognitive impairment (Montreal Cognitive assessment score \<26/30)
- Verbal Aphasia (i.e \<71% score on Mississippi Aphasia Screening)
- Severe depression (\> 15 points on geriatric depression scale)
- Any neurological condition other than stroke.
- Uncontrolled and/or untreated hypertension/hypotension, uncontrolled and/or untreated diabetes and any musculoskeletal, neuromuscular or systemic diagnosis .
- Recent major surgery (\< 6 months) or hospitalization (\< 3 months).
- Deep venous thrombosis.
- Past or current history of any type of active cancer
- Peripheral nerve injury or neuropathy in the affected limb with motor disability.
- Uncontrolled high blood pressure/angina.
- Skin condition not tolerant with FES therapy.
- Past or current history of uncontrolled/controlled epilepsy or any other types of seizure disorders
- Botox treatment within the last 5 months.
- Pacemaker users. \-
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.