Sensory Stimulation to Enhance Hand Function Post Stroke

Completed

Phase N/A Results N/A

Trial Description

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.

Detailed 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, thus improving their quality of life.

Conditions

Interventions

  • Vibration Other
    Intervention Desc: peripheral vibration at the wrist skin at an imperceptible level
    ARM 1: Kind: Experimental
    Label: Experimental
    Description: The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.
  • Placebo (for vibration) Other
    Intervention Desc: No peripheral vibration at the wrist skin
    ARM 1: Kind: Experimental
    Label: Placebo
    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.
  • Therapy Behavioral
    Intervention Desc: standardized hand therapy program
    ARM 1: Kind: Experimental
    Label: Experimental
    Description: The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.
    ARM 2: Kind: Experimental
    Label: Placebo
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in the Nine Hole Peg Test score within a week after the 2 week therapy (or week 3) No
Secondary Change in the corticomotor excitability measured by transcranial magnetic stimulation within a week after the 2 week therapy (or week 3) Yes
Secondary Change in the electroencephalogram (EEG) somatosensory evoked potential within a week after the 2 week therapy (or week 3) No
Secondary Change in the diffusion kurtosis imaging (DKI) within a week after the 2 week therapy (or week 3) Yes
Secondary Change in the Action Research Arm Test score 2 weeks after the 2 week therapy (or week 5) No
Secondary change in the EEG peak-to-peak power change observed with grip within a week after the 2 week therapy (or week 3) No
Secondary change in the blood oxygen level dependent (BOLD) signal intensity at rest within a week after the 2 week therapy (or week 3) Yes
Secondary change in the blood oxygen level dependent (BOLD) signal intensity with grip within a week after the 2 week therapy (or week 3) Yes
Secondary change in the EEG somatosensory evoked potential 2 weeks after the 2 week therapy (or week 5) No
Secondary change in the peak-to-peak EEG power change observed with grip 2 weeks after the 2 week therapy (or week 5) No
Secondary change in DKI 2 weeks after the 2 week therapy (or week 5) Yes
Secondary Change in the Fugl-Meyer Upper Extremity score within a week after the 2 week therapy (or week 3) No
Secondary Change in the Semmes-Weinstein Monofilament Test score within a week after the 2 week therapy (or week 3) No
Secondary Change in the Box and Block Test score within a week after the 2 week therapy (or week 3) No
Secondary Change in the Purdue Peg Board Test score within a week after the 2 week therapy (or week 3) No
Secondary Change in the maximum grip force measured on grip force dynamometer within a week after the 2 week therapy (or week 3) No
Secondary Change in the Stroke Impact Scale within a week after the 2 week therapy (or week 3) No
Secondary Change in the Wolf Motor Function Test hand items score within a week after the 2 week therapy (or week 3) No
Secondary Change in the Grating Orientation Task score within a week after the 2 week therapy (or week 3) No
Secondary Change in the Stroke Specific Quality of Life score within a week after the 2 week therapy (or week 3) No
Secondary Change in the Two-point discrimination score within a week after the 2 week therapy (or week 3) No

Sponsors