Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke
NCT03986320 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2019-10-29
Summary
A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the Keeogo™ Dermoskeleton in subjects with hemiparesis due to ischemic or hemorrhagic stroke.
Conditions
- Stroke, Ischemic
- Stroke Hemorrhagic
- Stroke
- Hemiparesis
- Cerebral Vascular Accident
Interventions
- DEVICE
-
Keeogo™ Dermoskeleton
This device is intended for use in rehabilitation institutions to assist individuals with hemiparesis due to stroke who are able to stand and initiate a step in performing ambulatory functions.
Sponsors & Collaborators
-
B-Temia, Inc.
lead INDUSTRY
Principal Investigators
-
Arun Jayaraman, PT, PhD. · Shirley Ryan Ability Lab (SRA)
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-22
- Primary Completion
- 2020-03-31
- Completion
- 2020-09-30
- FDA Device
- Yes
Countries
- United States
- Canada
Study Locations
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