Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Stroke; Physical Disability

Treatments: Behavioral: therapy; Other: peripheral vibration stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04026399

Pro00086207

P20GM109040 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impact on functional ability and independence. One way to improve hand function is to use peripheral sensory stimulation. Sensory stimulation in conjunction with therapy has been shown to improve motor outcomes more than therapy alone. While promising, most modalities of sensory stimulation interfere with natural hand tasks. To address these practical limitations, we have developed a new stimulation, imperceptible random-frequency vibration applied to wrist skin via a watch. In this study, we will determine if use of this vibration increases hand functional recovery.

Full description

The study design is a double-blinded randomized controlled study. Subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly evaluation. Follow-up evaluation will occur 3 months after. The device will deliver vibration (treatment) or no vibration (control).

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic stroke survivor (>= 6 months post stroke)
• Ability to move an object with the paretic hand
• Fingertip sensory deficits
• Ability to put on a watch daily (by oneself or with help)

Exclusion criteria

• Currently undergoing other upper extremity rehabilitation therapy
• Upper limb botulinum toxin within 3 months prior to or during enrollment
• Change in neurological disorder medications during the enrollment
• Complete upper limb deafferentation
• Rigidity (Modified Ashworth Scale=5)
• Brainstem stroke
• Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
• Language barrier or cognitive impairment that precludes following instructions and/or providing consent

If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups

stimulation + therapy

Experimental group

Description:

The participant receives stimulation and home therapy.

Treatment:

Behavioral: therapy

Other: peripheral vibration stimulation

no stimulation + therapy

Sham Comparator group

Description:

The participant receives no stimulation and receives home therapy.

Treatment:

Behavioral: therapy