Optimizing Training in Severe Post-Stroke Walking Impairment (NCT04721860) | Clinical Trial Compass
CompletedNot Applicable
Optimizing Training in Severe Post-Stroke Walking Impairment
United States18 participantsStarted 2020-10-15
Plain-language summary
Difficulty walking is common after a stroke. Although physical rehabilitation helps a little with the improvement of walking ability, recovery is usually incomplete. The purpose of this study is to explore how two different treadmill training approaches influence walking speed, symmetry, and balance in people with chronic severe stroke-related walking impairment. The two approaches involve either forward or backwards treadmill training. This study will look at changes in walking performance and balance, before and after training. This study may lead to more efficient methods for improving walking performance and balance after stroke.
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:
* 18-80 years of age
* Walking speed less than or equal to 0.4 meters/second
* Ability to maintain greater than or equal to 0.3mph speed for 6-minute interval on the treadmill
* Able to walk independently (cane and hemi-walker acceptable)
* Ambulate \>10 meters over ground with the Free Step Harness System (as a safety precaution)
* Discharged from formal rehabilitation
Exclusion Criteria:
* Unstable cardiac status which would preclude participation in a moderate-intensity exercise program.
* Significant language barrier which might prevent the participant from following instructions during training and testing.
* Adverse health condition that might affect walking capacity (severe arthritis, significant pulmonary disease significant ataxia, or severe hemi-neglect)
* Severe lower extremity spasticity (Ashworth \>2)
* Depression (\>10 on the Patient Health Questionnaire, if untreated).
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 in 10-Meter Walk (fast)
Timeframe: Pre-Baseline (Day of Randomization) to One Day Post-Training