Clinical trial NCT03318341: TheraBracelet Phase I
Official title: TheraBracelet Phase I Small Business Technology Transfer Research (STTR) - The 1st and Only Wearable to Instantly Improve Hand Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Function
Stroke
Upper Extremity
Hemiparesis
Cerebrovascular Accident
Stroke Rehabilitation
Keywords: physical stimulation
Subliminal stimulation
stroke rehabilitation
upper extremity
paresis
patient safety
Lead sponsor: TheraBracelet, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medical University of South Carolina
First posted: 2017-10-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety - Occurrence of Device-Related Adverse Events (AE)
timeFrame: Two 1-month durations
measure: Feasibility - User Compliance in Wearing the Device
timeFrame: Two 1-month durations
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Na Jin Seo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.