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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Stroke; Physical Disability

Treatments: Device: No stimulation; Device: real stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04569123

1R01HD094731-01A1 (U.S. NIH Grant/Contract)

Pro90790

Details and patient eligibility

About

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

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

61 participants in 2 patient groups

Vibration

Active Comparator group

Description:

The device will deliver imperceptible vibration for the treatment group.

Treatment:

Device: real stimulation

No Vibration

Sham Comparator group

Description:

The device will deliver no vibration for the control group.

Treatment:

Device: No stimulation