N/A
N=26
TheraBracelet Phase I
Hand Function · Stroke · Upper Extremity · Hemiparesis · Cerebrovascular Accident
Bottom Line
View on ClinicalTrials.gov: NCT03318341 ↗Enrolled (actual)
26
Serious AEs
6.0%
Results posted
Mar 2019
Primary outcome: Primary: Safety - Occurrence of Device-Related Adverse Events (AE) — 2; 4; 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Real Stimulation (Device); Sham Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TheraBracelet, Inc.
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety - Occurrence of Device-Related Adverse Events (AE) |
2; 4; 0; 1 | — |
| PRIMARY Feasibility - User Compliance in Wearing the Device |
13; 12; 13; 12 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03318341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.