TheraBracelet Phase I

TheraBracelet

Status: Completed

Conditions: Cerebrovascular Accident; Stroke; Hand Function; Stroke Rehabilitation; Upper Extremity; Hemiparesis

Treatments: Device: Sham Stimulation; Device: Real Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03318341

1R41HD090792-01A1

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups

Real then Sham

Other group

Description:

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.

Treatment:

Device: Sham Stimulation

Device: Real Stimulation

Sham then Real

Other group

Description:

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.

Treatment:

Device: Sham Stimulation

Device: Real Stimulation