Smartwatch App for Vibration Stimulation

March 5, 2020 updated by: Medical University of South Carolina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Caorlina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real stimulation
The smartwatch produces vibration stimulation.
Device: real stimulation
The smartwatch generates imperceptible vibratory stimulation.
Sham Comparator: No stimulation
The smartwatch produces no vibration.
Device: no stimulation
The smartwatch generates no stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block Test
Time Frame: 20 minute
number of blocks moved
20 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nine Hole Peg Test
Time Frame: 20 minute
time it takes to complete the test
20 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

MUSC Foundation for Research Development

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2019

Primary Completion (Actual)

January 3, 2020

Study Completion (Actual)

January 3, 2020

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

August 7, 2019

First Posted (Actual)

August 9, 2019

Study Record Updates

Last Update Posted (Actual)

March 6, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00088976

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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