Status:
COMPLETED
Personalized Post-Stroke Gait Rehabilitation Interventions
Lead Sponsor:
Boston University Charles River Campus
Collaborating Sponsors:
Harvard University
American Heart Association
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The objective of this study is to understand whether certain post-stroke patient subsets, identified from clinical, biomechanical, and neuromuscular characteristics, preferentially respond to differen...
Detailed Description
Stroke is a leading cause of long-term disability that results in slow, asymmetrical, and inefficient walking. Personalized treatments matching patients to the treatments with which they are most like...
Eligibility Criteria
Inclusion
- Diagnosis of a stroke event occurring at least 6 months ago
- Observable gait deficits
- Independent ambulation for at least 30 meters (using an assistive device as needed but without a rigid brace or ankle foot orthosis)
- Passive ankle dorsiflexion range of motion to neutral with the knee extended
- Ability to follow a 3-step command
- Resting heart rate between 40-100 bpm
- Resting blood pressure between 90/60 and 170/90 mmHg
- NIH Stroke Scale Question 1b score \> 1 and Question 1c score \> 0
- HIPAA authorization to allow communication with healthcare provider
- Medical clearance by a physician
Exclusion
- Severe aphasia or inability to communicate with investigators
- Neglect or hemianopia
- Score of \>1 on question 1b and \>0 on question 1c on the NIH Stroke Scale
- Serious comorbidities that may interfere with ability to participate in the research (e.g., musculoskeletal, cardiovascular, pulmonary)
- Pacemakers or similar electrical implants that could be affected by the FES
- Pressure ulcers or skin wounds located near human-device interface sites
- More than 2 unexplained falls in the previous month
- Actively receiving physical therapy for walking
Key Trial Info
Start Date :
September 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT07212608
Start Date
September 13 2022
End Date
April 24 2025
Last Update
October 8 2025
Active Locations (1)
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1
Boston University Neuromotor Recovery Laboratory
Boston, Massachusetts, United States, 02215