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Behavioural Intervention
Perturbation Training for Stroke Survivors
N/A
Recruiting
Led By Tanvi Bhatt, PhD PT
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
Ability to walk at least 10m with or without assistive device which includes use of ankle orthosis or functional electrical stimulation devices (which is equivalent to having a score of> 4, dependent supervision on Functional Ambulatory category scale)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up retrospectively assessed via participant history for 12 months before pretest and prospectively assessed for 12 months post training via falls diary
Awards & highlights
Summary
This trial is testing a training paradigm to reduce falls for stroke survivors. It is a novel approach that targets both limbs to reduce fall risk.
Who is the study for?
This trial is for stroke survivors who can walk at least 10 meters with or without help, have had a stroke over 6 months ago confirmed by their doctor and brain scans. They should not have other major health issues, recent surgeries, hospital stays, or be on sedatives.
What is being tested?
The study tests a new training method to prevent falls in people who've had strokes. It involves slip-perturbation training that focuses on improving balance and walking function by first training the non-affected limb then the affected one.
What are the potential side effects?
While specific side effects are not detailed, this physical intervention may include muscle soreness, fatigue or potential increase in fall risk during initial learning phases of perturbation training.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk at least 10 meters, with or without help like a cane or brace.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ retrospectively assessed via participant history for 12 months before pretest and prospectively assessed for 12 months post training via falls diary
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~retrospectively assessed via participant history for 12 months before pretest and prospectively assessed for 12 months post training via falls diary
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in laboratory induced falls
Change in real life falls
Secondary outcome measures
Change in Limb support
Change in Stability
Change in gait speed
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Slip training for sub-acute strokeExperimental Treatment1 Intervention
Sub-acute stroke survivors in this training group will receive bilateral overground, slip perturbation training.
Group II: Slip training for chronic strokeExperimental Treatment1 Intervention
Chronic stroke subjects in this training group will receive bilateral overground, slip perturbation training.
Group III: Control for sub-acute strokeActive Control1 Intervention
Sub-acute stroke subjects, after baseline walking trials, will walk for about 30 trials at their preferred walking pace to match the total trials the other groups receive before receiving a single slip each randomly on their non-paretic and paretic sides.
Group IV: Control for chronic strokeActive Control1 Intervention
Chronic stroke subjects, after baseline walking trials, will walk for about 30 trials at their preferred walking pace to match the total trials the other groups receive before receiving a single slip each randomly on their non-paretic and paretic sides.
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,014 Previous Clinical Trials
2,696,653 Total Patients Enrolled
79 Trials studying Stroke
5,212 Patients Enrolled for Stroke
University of Illinois at ChicagoLead Sponsor
632 Previous Clinical Trials
1,567,534 Total Patients Enrolled
18 Trials studying Stroke
2,086 Patients Enrolled for Stroke
Tanvi Bhatt, PhD PTPrincipal Investigator - University of Illinois at Chicago
University of Illinois at Chicago
1 Previous Clinical Trials
600 Total Patients Enrolled
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