Stroke, Physical Disability
Conditions
Keywords
physical stimulation, subliminal stimulation, stroke rehabilitation, physical therapy, occupational therapy, upper extremity, paresis, hand function
Brief 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.
Interventions
DEVICEreal 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.
DEVICENo 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.
Sponsors
Medical University of South Carolina
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wolf Motor Function Test (WMFT) Movement Time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Box and Blocks Test (BBT) Score | 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. |
| Change in Action Research Arm Test (ARAT) Score | 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62 year STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 31 |
| other Total, other adverse events | 25 / 30 | 23 / 31 |
| serious Total, serious adverse events | 3 / 30 | 2 / 31 |
Outcome results
None listed