TheraBracelet Phase I

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03318341
Study type	Interventional
Source	TheraBracelet, Inc.
Contact
Status	Completed
Phase	N/A
Start date	January 9, 2018
Completion date	November 28, 2018

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.