Biofeedback to Increase Propulsion During Walking After Stroke (NCT02667392) | Clinical Trial Compass
CompletedPhase 1
Biofeedback to Increase Propulsion During Walking After Stroke
United States11 participantsStarted 2017-10-02
Plain-language summary
Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. Rehabilitation of walking ability contributes to these costs. To "walk again" is the number one stated goal for Veterans who have had a stroke. Teaching patients post-stroke to use their weak leg while they are regaining walking function and to not compensate by over-using their strong leg is necessary to restore safe, efficient walking ability. This project will determine if providing biofeedback (an audible tone) from pressure-sensitive shoe insole sensors, that encourage use of the weaker leg during walking training, in addition to therapists' feedback, will help Veterans regain use of their weak leg, improve their endurance and improve their balance when walking in challenging environments.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
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:
* Diagnosis of stroke
* \> 6 months \< 5 years post-stroke onset
* Medically stable
* 18-80 years of age
* Impaired lower extremity sensation confirmed by a score of \< 12 on the Fugl-Meyer Sensory Assessment,20
* Community-dwelling
* Step length asymmetry (paretic step length \> non-paretic step length)
* this asymmetry has been determined to be correlated with minimal propulsive force of the paretic leg4
* Unilateral lower extremity paresis confirmed by a score of \< 32 on the Fugl-Meyer Motor Assessment,20
* Able to ambulate without an orthotic device
* Able to ambulate without an assistive device
* Ambulation of household distances without physical assistance to advance or support paretic lower extremity
Exclusion Criteria:
* Presence of a neurological condition other than stroke
* Pain upon ambulation
* Receiving physical therapy services for mobility and/or gait
* Severe arthritis or orthopedic problems that limit passive ranges of motion
* knee flexion contracture of -10 , knee flexion range of motion (ROM) \< 90
* hip flexion contracture \> 25
* ankle plantar flexion contracture \> 15
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Forward Propulsion of the Paretic Limb From Pre- to Post-intervention
Timeframe: Pre-intervention (prior to 1st intervention session) and Post-intervention (after the final (12th intervention session), approximately 4 weeks after entering the study.