Skip to main content
OpenTrials
Completed

NCT Number: NCT04050917

Smartwatch App for Vibration Stimulation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Caorlina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Real Stimulation

Device

The smartwatch generates imperceptible vibratory stimulation.

No stimulation

Device

The smartwatch generates no stimulation.

Primary outcomes

  1. Box and Block Test

    Time frame: 20 minute

    number of blocks moved

Secondary outcomes

  1. Nine Hole Peg Test

    Time frame: 20 minute

    time it takes to complete the test

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • MUSC Foundation for Research Development

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 9, 2019
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.