Smartwatch App for Vibration Stimulation
Primary Purpose
Stroke, Physical Disability
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
real stimulation
no stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring physical stimulation, Subliminal stimulation, stroke rehabilitation, upper extremity, paresis, hand function, occupational therapy, physical therapy
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.
Sites / Locations
- Medical University of South Caorlina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Real stimulation
No stimulation
Arm Description
The smartwatch produces vibration stimulation.
The smartwatch produces no vibration.
Outcomes
Primary Outcome Measures
Box and Block Test
number of blocks moved
Secondary Outcome Measures
Nine Hole Peg Test
time it takes to complete the test
Full Information
NCT ID
NCT04050917
First Posted
August 7, 2019
Last Updated
March 5, 2020
Sponsor
Medical University of South Carolina
Collaborators
MUSC Foundation for Research Development
1. Study Identification
Unique Protocol Identification Number
NCT04050917
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
January 3, 2020 (Actual)
Study Completion Date
January 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
MUSC Foundation for Research Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Physical Disability
Keywords
physical stimulation, Subliminal stimulation, stroke rehabilitation, upper extremity, paresis, hand function, occupational therapy, physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real stimulation
Arm Type
Experimental
Arm Description
The smartwatch produces vibration stimulation.
Arm Title
No stimulation
Arm Type
Sham Comparator
Arm Description
The smartwatch produces no vibration.
Intervention Type
Device
Intervention Name(s)
real stimulation
Intervention Description
The smartwatch generates imperceptible vibratory stimulation.
Intervention Type
Device
Intervention Name(s)
no stimulation
Intervention Description
The smartwatch generates no stimulation.
Primary Outcome Measure Information:
Title
Box and Block Test
Description
number of blocks moved
Time Frame
20 minute
Secondary Outcome Measure Information:
Title
Nine Hole Peg Test
Description
time it takes to complete the test
Time Frame
20 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Medical University of South Caorlina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Smartwatch App for Vibration Stimulation
We'll reach out to this number within 24 hrs