Status:
UNKNOWN
Robotic Exosuit Augmented Locomotion (REAL)
Lead Sponsor:
Lou Awad, PT, DPT, PhD
Collaborating Sponsors:
Harvard University
Spaulding Rehabilitation Hospital
Conditions:
Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Previous studies of the exosuit technology have culminated in strong evidence for the gait-restorative effects of soft robotic exosuits for patients post-stroke by means of substitution for lost funct...
Detailed Description
Weakness of the ankle plantarflexors after a stroke results in impaired forward propulsion during walking, which consequently impacts walking efficiency and speed - parameters that are necessary for c...
Eligibility Criteria
Inclusion
- Age 18 - 80 years old
- Stroke event occurred at least 6 months ago
- Observable gait deficits
- Gait speed equal to or less than 1 m/s
- Able to walk without the support of another person for at least 6 minutes (may use an assistive device as needed, but without use of an ankle foot orthosis or brace)
- Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)
- Resting heart rate between 40 - 100 bpm, inclusive
- Resting blood pressure between 90/60 and 170/90 mmHg, inclusive
Exclusion
- Score of \>1 on question 1b and \>0 on question 1c on the NIH Stroke Scale
- Inability to communicate with investigators
- Neglect or hemianopia
- Actively receiving physical therapy for walking
- History of cerebellar strokes
- Known recurring or repeating strokes
- Unexplained dizziness in the last 6 months
- Pressure ulcers or skin wounds located at human-device interface sites
- Other medical, orthopedic, and neurological conditions that prevent full participation in the research
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04818424
Start Date
February 24 2021
End Date
July 1 2022
Last Update
December 29 2021
Active Locations (3)
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1
Harvard University
Boston, Massachusetts, United States, 02134
2
Boston University
Boston, Massachusetts, United States, 02215
3
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02129