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Completed

NCT Number: NCT02675764

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibration

Other

peripheral vibration at the wrist skin at an imperceptible level

Placebo (for vibration)

Other

No peripheral vibration at the wrist skin

Therapy

Behavioral

standardized hand therapy program

Primary outcomes

  1. Box and Block Test (BBT) About a Week After the 2-week Intervention

    Time frame: post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)

    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.

  2. Box and Block Test (BBT) at Least 2 Weeks After the 2-week Intervention

    Time frame: follow up (at least 2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)

    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.

  3. WMFT About a Week After the 2-week Intervention

    Time frame: post intervention (about a week after the 2-week therapy, or week 3) compared to baseline (before 2-week therapy)

    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.

  4. WMFT at Least 2 Weeks After the 2-week Intervention

    Time frame: follow up (2 weeks after the 2-week therapy, or week 5) compared to baseline (before 2-week therapy)

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 5, 2016
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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