Sensory Stimulation to Enhance Hand Function Post Stroke

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Stroke

Treatments: Behavioral: therapy; Other: Placebo (for vibration); Other: Vibration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02675764

PRO42759

P20GM109040 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The objective of this pilot project is to assess the impact of the novel sensory stimulation technique the investigators have developed in enhancing outcomes of hand therapy as well as the central nervous system responsiveness in chronic stroke survivors.

Full description

Stroke survivors suffer from persistent hand impairment that diminishes their functional abilities and independence, despite multiple courses of rehabilitation. Sensory stimulation can prime central excitability to increase therapy outcome. The investigators developed a new sensory stimulation technique for the hand, using imperceptible vibration applied to the wrist skin. Wearable devices with a vibrating function are low cost and can be easily adopted for rehabilitation purposes to impact a wide range of patients with sensorimotor impairment. Despite the potential for clinical benefits and easy adoption for high impact, knowledge about the long-term efficacy of this new sensory stimulation technique and its underlying mechanism is limited.

The objective of this pilot project is to assess the impact of the novel sensory stimulation technique the investigators have developed in enhancing outcomes of 2-week hand therapy as well as the central nervous system responsiveness in chronic stroke survivors. This impact will be assessed in a double-blind stratified randomized controlled trial. The hypothesis is that (a) improvement in hand function will be greater for the experimental group receiving the wrist subthreshold vibrotactile stimulation during therapy compared with the control group who will wear the device with no vibration (placebo). (b) Improvement in hand function is associated with neurophysiologic measures of central nervous system responsiveness. Clinical and neurophysiologic evaluations will be performed before, immediately after, and 2 weeks after a 2 week standardized hand therapy program with the subthreshold vibrotactile stimulation to the wrist vs. sham. The investigators preliminary studies demonstrated an acute effect of the remote subthreshold vibrotactile stimulation on immediately improved clinical sensory and motor function of the hand as well as cortical excitability in healthy young adults and chronic stroke survivors in single-session studies.

The expected outcome is the demonstration that the subthreshold vibrotactile stimulation at the wrist enhances hand function, not only immediately (preliminary studies) but also as a complement to therapy in chronic stroke survivors. This project will also provide preliminary insights regarding plasticity occurring with hand therapy augmented by the subthreshold vibrotactile stimulation. This research will have a positive impact by leading to a portable sensorimotor orthosis worn at the wrist to improve hand function for patients with sensorimotor deficits.

Enrollment: 12 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• mild to moderate impairment in upper extremity function

Exclusion criteria

• cognitive dysfunction
• stroke<3 months
• treatment with botulinum toxin in the affected arm within 3 months of start of study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups

Experimental

Experimental group

Description:

The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.

Treatment:

Other: Vibration

Behavioral: therapy

Placebo

Active Comparator group

Description:

The control group will wear the vibration device with no vibration. * Both groups cannot feel the vibration since the vibration intensity is set below the perceptible level. * The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.

Treatment:

Behavioral: therapy

Other: Placebo (for vibration)