Status:
COMPLETED
TheraBracelet Phase I
Lead Sponsor:
TheraBracelet, Inc.
Collaborating Sponsors:
Medical University of South Carolina
Conditions:
Hand Function
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This project aims to test a new technology that may improve hand function impaired from a stroke, thereby improving independence and quality of life.
Detailed Description
Post-stroke hand impairment is highly prevalent and severely restricts functional ability and independence. Yet, there is no assistive device to help hand function at home, every day, during activitie...
Eligibility Criteria
Inclusion
- Age: 18 years or older
- Time since stroke: \> 3 months
- Those with at least some movement in the affected upper limb
- Ability to put on the device at home
- Ability to perform the Box and Block Test with a score \> 0
Exclusion
- Comorbidity such as neuropathy, orthopaedic conditions in the hand
- Compromised skin integrity of the hand/wrist.
- Participation in an upper limb rehabilitation program concurrently
- Pregnancy
- A language barrier or cognitive impairment that precludes following
- Individuals whose swelling changes dramatically during the day
- Participant has received Botulinum toxin injection in the past 3 months
- Inability or unwillingness of subject or legal guardian/representative to give informed consent
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03318341
Start Date
January 9 2018
End Date
November 28 2018
Last Update
May 7 2019
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425