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

Medical University of South Carolina61 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Stroke Physical Disability

Interventions

real stimulationDEVICE

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 stimulationDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Change in Wolf Motor Function Test (WMFT) Movement Time

The Wolf Motor Function Test (WMFT) is a standardized, timed assessment of upper extremity motor function. This study reports the total average movement time across the WMFT tasks. Range: 0 seconds to \>120 seconds (no fixed upper limit). Interpretation: Lower movement times indicate better motor function. Only this WMFT movement-time variable was analyzed as the pre-specified primary outcome.

Time frame: Baseline and 6 weeks

Secondary Outcomes

Change in Box and Blocks Test (BBT) Score

The Box and Blocks Test (BBT) measures unilateral gross manual dexterity. Participants move as many blocks as possible from one side of a box to the other in 60 seconds. Range: 0-150 blocks (typical). Interpretation: Higher scores indicate better manual dexterity.

Time frame: Baseline and 6 weeks

Change in Action Research Arm Test (ARAT) Score

The Action Research Arm Test (ARAT) is a standardized measure of upper limb functional ability. It contains 19 items scored 0-3, summed to a total score. Range: 0-57. Interpretation: Higher scores indicate better upper limb function.

Time frame: Baseline and 6 weeks

Data from ClinicalTrials.gov

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