Medical University of South Carolina
Charleston, South Carolina, 29403, United States
NCT Number: NCT04569123
The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29403, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline and 6 weeks
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
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
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.
Medical University of South Carolina
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