TheraBracelet Phase I

Stroke Clinical Trial

Official title:

TheraBracelet Phase I Small Business Technology Transfer Research (STTR) - The 1st and Only Wearable to Instantly Improve Hand Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03318341
• Other study ID #: 1R41HD090792-01A1
• Status: Completed
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: November 28, 2018

Study information

• Verified date: April 2019
• Source: TheraBracelet, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 activities of daily living. Existing devices such as hand-opening orthoses are expensive, uncomfortable, bulky, and meant for use during short therapy sessions as opposed to during daily living. Thus their impact is limited. Consequently, the development of efficacious and affordable assistive device is of importance. This project addresses this critical gap by providing an innovative patent-pending technology. The "TheraBracelet" is a wristband applying imperceptible vibration to skin. TheraBracelet is efficacious, as it has been shown to immediately improve chronic stroke survivors' touch sensation and hand dexterity in previous studies. TheraBracelet is affordable by using only a low-cost vibrator. TheraBracelet is also translational, because a vibrator strategically placed at the wrist does not interfere with dexterous finger motions, and it is low-risk by involving only imperceptible vibration on skin. These practicalities assure easy adoption in home environment for large impact on sensorimotor impairment. The essential next step, thus the objective of this Phase I project, is to determine the feasibility and safety of using this assistive device all day every day for a month during daily activity. This objective will be accomplished in a double-blinded, randomized, controlled, crossover design study. Feasibility (compliance of using the device everyday) and safety will be assessed for the real vibration condition compared to the sham vibration condition (wearing the device without vibration). The feasibility and safety level comparable to those of wearing a watch and of a comparable FDA-approved device will support viability of TheraBracelet with necessary regulatory approvals. This project is expected to lead to an assistive wristband that increases hand function during activities of daily living for a large number of stroke survivors with hand impairment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 28, 2018
• Est. primary completion date: October 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Hand Function
• Hemiparesis
• Paresis
• Stroke
• Stroke Rehabilitation
• Upper Extremity

Intervention

Device:
• Real Stimulation
The device applies wrist vibration at a subthreshold (imperceptible) level.
• Sham Stimulation
The device applies no vibration.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
TheraBracelet, Inc.	Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Occurrence of Device-Related Adverse Events (AE)	Any worsening of hand sensation, dexterity, grip strength, upper limb pain, swelling, spasticity, skin irritation, or any other adverse events (assessed every week) that sustained until the end of the month or occurred at the end of the month.	Two 1-month durations
Primary	Feasibility - User Compliance in Wearing the Device		Two 1-month durations