TheraBracelet Phase I

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

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

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiparesis; Cerebrovascular Accident; Stroke Rehabilitation; Upper Extremity; Hand Function
• Intervention / Treatment: Device: Real Stimulation; Device: Sham Stimulation

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 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
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Real then Sham; Participants are instructed to wear the TheraBracelet device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. After 2-week washout, participants are again instructed to wear the device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. The device applies real stimulation in the first month. The device applies sham stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.	Device: Real Stimulation; The device applies wrist vibration at a subthreshold (imperceptible) level.; Device: Sham Stimulation; The device applies no vibration.
OTHER: Sham then Real; Participants are instructed to wear the TheraBracelet device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. After 2-week washout, participants are again instructed to wear the device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. The device applies sham stimulation in the first month. The device applies real stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.	Device: Real Stimulation; The device applies wrist vibration at a subthreshold (imperceptible) level.; Device: Sham Stimulation; The device applies no vibration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Feasibility - User Compliance in Wearing the Device		Two 1-month durations

Collaborators and Investigators

• Sponsor: TheraBracelet, Inc.
• Collaborators: Medical University of South Carolina

Publications and helpful links

General Publications

• Seo NJ, Enders LR, Fortune A, Cain S, Vatinno AA, Schuster E, Ramakrishnan V, Feng W. Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. Transl Stroke Res. 2020 Apr;11(2):204-213. doi: 10.1007/s12975-019-00724-9. Epub 2019 Aug 23.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 9, 2018
• Primary Completion (ACTUAL): October 22, 2018
• Study Completion (ACTUAL): November 28, 2018

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (ACTUAL): October 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: paresis; patient safety; upper extremity; stroke rehabilitation; physical stimulation; Subliminal stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: 1R41HD090792-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request.
• IPD Sharing Time Frame: The data will become available within 1 year from the study completion date for 6 years.
• IPD Sharing Access Criteria: De-identified data only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes