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Perturbation Training for Stroke
N/A
Recruiting
Led By Jesse Dean
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gait speed of at least 0.2 m/s
Ability to walk on a treadmill without a cane or walker
Must not have
History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 32 weeks (12-week period pre-intervention; 12-week period post-intervention)
Awards & highlights
No Placebo-Only Group
Summary
This trial investigates whether two methods of delivering mechanical perturbations during walking can improve post-stroke walking balance and reduce real-world fall incidence for stroke patients.
Who is the study for?
This trial is for individuals who had a stroke at least 6 months ago, have experienced falls or fear falling, can walk on a treadmill without support, and have a walking speed of at least 0.2 meters per second. It's not suitable for those with certain heart conditions, other neurological disorders or dementia, severe lower limb orthopedic issues, cerebellar damage, extremely high blood pressure, significant visual impairments, recent DVT/pulmonary embolism events or uncontrolled diabetes.
What is being tested?
The study examines two types of mechanical perturbations during walking—proactive and reactive—to see if they improve balance and reduce the risk of falls in post-stroke patients. Participants will be subjected to these perturbations while walking to assess their effectiveness in enhancing stability.
What are the potential side effects?
While specific side effects are not listed for this type of physical intervention trial, participants may experience discomfort or muscle soreness due to the unusual walking challenges presented by the perturbations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk at a speed of at least 0.2 meters per second.
Select...
I can walk on a treadmill without needing a cane or walker.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of serious heart conditions.
Select...
I have a leg or foot condition that affects how I walk.
Select...
I am legally blind or have severe trouble seeing.
Select...
I have diabetes with recent weight loss, diabetic coma, or frequent insulin reactions.
Select...
I have damage to the part of my brain that controls balance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 32 weeks (12-week period pre-intervention; 12-week period post-intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~32 weeks (12-week period pre-intervention; 12-week period post-intervention)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fall incidence
Secondary study objectives
Activities-specific Balance Confidence scale
Angular momentum modulation (trained perturbations) Largest rejected perturbation (trunk)
Angular momentum modulation (untrained perturbations) Largest rejected perturbation (trunk)
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Reactive PerturbationsExperimental Treatment1 Intervention
Group II: Proactive PerturbationsExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
978 Previous Clinical Trials
7,400,843 Total Patients Enrolled
73 Trials studying Stroke
62,199 Patients Enrolled for Stroke
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,067 Previous Clinical Trials
2,747,378 Total Patients Enrolled
86 Trials studying Stroke
5,767 Patients Enrolled for Stroke
Jesse DeanPrincipal InvestigatorMedical University of South Carolina
Media Library
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.