TheraBracelet Phase I

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Stroke Rehabilitation, Hand Function, Stroke, Upper Extremity, Hemiparesis, Cerebrovascular Accident

Intervention / Treatment
-----------------
* Device: Real Stimulation
* Device: Sham Stimulation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The study will use a 2×2 crossover design. Participants will be randomly assigned to either the treatment or control condition for the first month, followed by a 2-week washout period and then crossover to the other condition.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Real then Sham<br>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<br>* The device applies wrist vibration at a subthreshold (imperceptible) level.<br>Device: Sham Stimulation<br>* The device applies no vibration.<br>|
| Other: Sham then Real<br>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<br>* The device applies wrist vibration at a subthreshold (imperceptible) level.<br>Device: Sham Stimulation<br>* The device applies no vibration.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical stimulation, Subliminal stimulation, stroke rehabilitation, upper extremity, paresis, patient safety