NCT04569123

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Physical Disability

Interventions

Type	Name	Description
DEVICE	real stimulation	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.
DEVICE	No stimulation	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.

Timeline

• Start date: 2020-11-02
• Primary completion: 2025-01-06
• Completion: 2025-01-13
• First posted: 2020-09-29
• Last updated: 2026-02-09
• Results posted: 2026-02-09

Locations

1 site across 1 country: United States