Clinical trial NCT04569123: Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke
Official title: Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Physical Disability
Keywords: physical stimulation
subliminal stimulation
stroke rehabilitation
physical therapy
occupational therapy
upper extremity
paresis
hand function
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-09-29
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Score of Wolf Motor Function Test (WMFT)
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Change in Score of Box and Blocks Test
timeFrame: Baseline and 6 weeks
measure: Change in Score of Action Research Arm Test
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: Seo NJ, Ramakrishnan V, Woodbury ML, Bonilha L, Finetto C, Schranz C, Scronce G, Coupland K, Blaschke J, Baker A, Howard K, Meinzer C, Velozo CA, Adams RJ. Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke. Trials. 2022 Apr 5;23(1):262. doi: 10.1186/s13063-022-06241-9.