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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT04569123

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke Physical Disability	Device: real stimulation Device: No stimulation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 2, 2020

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vibration The device will deliver imperceptible vibration for the treatment group.	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.
Sham Comparator: No Vibration The device will deliver no vibration for the control 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.

Arm

Intervention/Treatment

Active Comparator: Vibration

The device will deliver imperceptible vibration for the treatment group.

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.

Sham Comparator: No Vibration

The device will deliver no vibration for the control group.

Device: No stimulation

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 (Modified Ashworth Scale=4-5)
Comorbidity such as complete upper extremity deafferentation, orthopaedic conditions limiting motion, premorbid neurologic conditions, peripheral neuropathy, or compromised skin integrity of the wrist due to burn or long-term use of blood thinners
Language barrier or cognitive impairment that precludes following instructions and/or providing consent