Smartwatch App for Vibration Stimulation

Stroke Clinical Trial

Official title:

Development of Wearable Stimulation App to Increase Hand Functional Recovery in Patients With Neurologic Movement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050917
• Other study ID #: Pro00088976
• Status: Completed
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: January 3, 2020

Study information

• Verified date: March 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 3, 2020
• Est. primary completion date: January 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Physical Disability
• Stroke

Intervention

Device:
• real stimulation
The smartwatch generates imperceptible vibratory stimulation.
• no stimulation
The smartwatch generates no stimulation.

Locations

Country	Name	City	State
United States	Medical University of South Caorlina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	MUSC Foundation for Research Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Box and Block Test	number of blocks moved	20 minute
Secondary	Nine Hole Peg Test	time it takes to complete the test	20 minute