Clinical trial NCT04050917: Smartwatch App for Vibration Stimulation
Official title: Development of Wearable Stimulation App to Increase Hand Functional Recovery in Patients With Neurologic Movement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Physical Disability
Keywords: physical stimulation
Subliminal stimulation
stroke rehabilitation
upper extremity
paresis
hand function
occupational therapy
physical therapy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: MUSC Foundation for Research Development
First posted: 2019-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine if the acute effect of vibration from a smartwatch on hand function is comparable to the effect of an existing laboratory prototype.

Detailed description: More than 4 million stroke survivors in the U.S. suffer from post-stroke hand disability. As hands are our primary means of interacting with the world, post-stroke hand impairment diminishes stroke survivors' abilities for activities of daily living including self-care, hygiene, employment, and leisure, and lowers independence. Hand impairment is difficult to treat. Limited resources in rehabilitation services and financial burdens make it impractical to simply increase rehabilitation service visits within the current healthcare system.

One way to augment hand function recovery is peripheral sensory stimulation. Afferent input is a powerful driver of change in the motor cortex. Sensory stimulation has been shown to improve motor recovery in previous studies. In particular, promising preliminary results have been obtained by using imperceptible random-frequency vibration applied via a watch. However, the laboratory prototype device for delivering this vibration must be improved in the form factor for patient adoption.

Therefore, we developed an App that can be installed in smartwatches and control the vibrator within the smartwatch to deliver vibratory stimulation to the user. The objective of this study is to determine if the acute effect of vibration from a smartwatch on hand function is comparable to the effect of an existing laboratory prototype.

Eligibility criteria: Inclusion Criteria:

* Age = 18 or older
* At least 6 months post stroke
* The ability to perform The Box and Block Test with a score greater than zero and less than 40.

Exclusion Criteria:

* Rigidity (Modified Ashworth Scale=5)
* Complete upper limb deafferentation
* Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
* Language barrier or cognitive impairment that precludes following instructions and/or providing consent.

Primary outcomes:
measure: Box and Block Test
timeFrame: 20 minute
Secondary outcomes:
measure: Nine Hole Peg Test
timeFrame: 20 minute
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Caorlina
state: South Carolina
Study officials:
References: