Status:
COMPLETED
Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Stroke
Physical Disability
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impa...
Detailed Description
The study design is a double-blinded randomized controlled study. Subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly...
Eligibility Criteria
Inclusion
- Chronic stroke survivor (\>= 6 months post stroke)
- Ability to move an object with the paretic hand
- Fingertip sensory deficits
- Ability to put on a watch daily (by oneself or with help)
Exclusion
- Currently undergoing other upper extremity rehabilitation therapy
- Upper limb botulinum toxin within 3 months prior to or during enrollment
- Change in neurological disorder medications during the enrollment
- Complete upper limb deafferentation
- Rigidity (Modified Ashworth Scale=5)
- Brainstem stroke
- 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
- If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS.
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04026399
Start Date
July 8 2019
End Date
October 15 2020
Last Update
August 23 2021
Active Locations (1)
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1
Medical University of South Caorlina
Charleston, South Carolina, United States, 29425