Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke

Not Applicable

Completed

• Conditions: Stroke; Physical Disability
• Interventions: Device: real stimulation; Device: No stimulation

• Registration Number: NCT04569123
• Lead Sponsor: Medical University of South Carolina

Brief Summary

The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.

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 Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-29
• Study Start: 2020-11-02
• Primary Completion: 2025-01-06
• Study Completion: 2025-01-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibration	real stimulation	The device will deliver imperceptible vibration for the treatment group.
No Vibration	No stimulation	The device will deliver no vibration for the control group.

Primary Outcome Measures

Name	Time	Method
Change in Score of Wolf Motor Function Test (WMFT)	Baseline and 6 weeks	Timed test of upper extremity function with a variety of tasks.

Secondary Outcome Measures

Name	Time	Method
Change in Score of Box and Blocks Test	Baseline and 6 weeks	Timed test of upper extremity function by moving blocks.
Change in Score of Action Research Arm Test	Baseline and 6 weeks	Timed test of upper extremity function through a variety of tasks.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States