- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04569123
Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is a leading cause of disability in the U.S., with more than 4 million stroke survivors in the U.S. who suffer from post-stroke hand disability. Post-stroke hand disability impairs stroke survivors' abilities and independence with self-care, hygiene, employment, and leisure, frequently resulting in diminished quality of life. Rehabilitation can often be limited, but research suggests that the effects of therapy is improved by the addition of sensory stimulation.
To fully leverage the potential therapeutic benefits of sensory stimulation, we have developed a new stimulation that is imperceptible random-frequency vibration applied to wrist skin. The objective of this study is to determine if this treatment is superior to task-practice alone in improving hand functional recovery, sensorimotor grip control, and neural communication.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Na Jin Seo, PhD
- Phone Number: 8437920084
- Email: seon@musc.edu
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29403
- Recruiting
- Medical University of South Carolina
-
Contact:
- Na Jin Seo, PhD
- Phone Number: 843-792-0084
- Email: seon@musc.edu
-
Principal Investigator:
- Na Jin Seo, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years old or older
- At least 6 months since stroke
- Wolf Motor Function Test (WMFT) total average time >10 seconds
- WFMT hand task average time <120 s
Exclusion Criteria:
- Currently undergoing other upper limb therapy
- Change in spasticity medication or upper limb botulinum toxin injection within 3 months prior to or during enrollment
- Severe spasticity that limits participation in task practice therapy (e.g., Modified Ashworth Scale=4-5)
- Comorbidity affecting the upper limb function such as complete upper extremity deafferentation, orthopaedic conditions limiting motion, premorbid neurologic conditions, premorbid peripheral neuropathy, compromised skin integrity of the wrist due to burn or long-term use of blood thinners, or significant new neurological symptoms
- Language barrier or cognitive impairment that precludes following instructions and/or providing consent
Study Plan
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 |
---|---|
Active Comparator: Vibration
The device will deliver imperceptible vibration for the treatment group.
|
Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist.
Participants will be randomized into two groups: The device will deliver vibration for the treatment group.
|
Sham Comparator: No Vibration
The device will deliver no vibration for the control group.
|
Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist.
Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Score of Wolf Motor Function Test (WMFT)
Time Frame: Baseline and 6 weeks
|
Timed test of upper extremity function with a variety of tasks.
|
Baseline and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Score of Box and Blocks Test
Time Frame: Baseline and 6 weeks
|
Timed test of upper extremity function by moving blocks.
|
Baseline and 6 weeks
|
Change in Score of Action Research Arm Test
Time Frame: Baseline and 6 weeks
|
Timed test of upper extremity function through a variety of tasks.
|
Baseline and 6 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro90790
- 1R01HD094731-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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