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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04569123
• Other study ID #: Pro90790
• Secondary ID: 1R01HD094731-01A
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: November 1, 2025

Study information

• Verified date: November 2023
• Source: Medical University of South Carolina
• Contact: Na Jin Seo, PhD
• Phone: 8437920084
• Email: seon[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Disability
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Score of Wolf Motor Function Test (WMFT)	Timed test of upper extremity function with a variety of tasks.	Baseline and 6 weeks
Secondary	Change in Score of Box and Blocks Test	Timed test of upper extremity function by moving blocks.	Baseline and 6 weeks
Secondary	Change in Score of Action Research Arm Test	Timed test of upper extremity function through a variety of tasks.	Baseline and 6 weeks