Sensory Stimulation to Enhance Hand Function Post Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Vibration; Behavioral: therapy; Other: Placebo (for vibration)

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; The experimental group receives the wrist subthreshold vibrotactile stimulation during therapy.	Other: Vibration; peripheral vibration at the wrist skin at an imperceptible level; Behavioral: therapy; standardized hand therapy program
Active Comparator: Placebo; 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.	Behavioral: therapy; standardized hand therapy program; Other: Placebo (for vibration); No peripheral vibration at the wrist skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Box and Block Test (BBT) About a Week After the 2-week Intervention	Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.	post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)
Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention	Change in hand motor function as measured by the Box and Block Test. This test measures the number of blocks that a participant moved in a minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.	follow up (at least 2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)
WMFT About a Week After the 2-week Intervention	change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.	post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)
WMFT at Least 2 Weeks After the 2-week Intervention	change in hand motor function as measured by the Wolf Motor Function Test hand items time. This test measures time to complete movements in seconds. More negative values represent greater reduction in time and thus better outcomes.	follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Study Chair: Steven Kautz, PhD, Medical University of South Carolina

Publications and helpful links

General Publications

• Seo NJ, Woodbury ML, Bonilha L, Ramakrishnan V, Kautz SA, Downey RJ, Dellenbach BHS, Lauer AW, Roark CM, Landers LE, Phillips SK, Vatinno AA. TheraBracelet Stimulation During Task-Practice Therapy to Improve Upper Extremity Function After Stroke: A Pilot Randomized Controlled Study. Phys Ther. 2019 Mar 1;99(3):319-328. doi: 10.1093/ptj/pzy143.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 30, 2017
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimated): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: hand function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PRO42759; P20GM109040 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO