TheraBracelet Phase I

TheraBracelet, Inc.26 enrolled

Overview

This project aims to test a new technology that may improve hand function impaired from a stroke, thereby improving independence and quality of life.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hand Function Stroke Upper Extremity Hemiparesis Cerebrovascular Accident Stroke Rehabilitation

Interventions

Real StimulationDEVICE

The device applies wrist vibration at a subthreshold (imperceptible) level.

Sham StimulationDEVICE

The device applies no vibration.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: Two 1-month durations

Feasibility - User Compliance in Wearing the Device

Time frame: Two 1-month durations

Data from ClinicalTrials.gov

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