TheraBracelet Phase I

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.

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