Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke

November 17, 2023 updated by: Na Jin Seo, Medical University of South Carolina
The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.

Study Overview

Status

Recruiting

Detailed Description

Stroke is a leading cause of disability in the U.S., with more than 4 million stroke survivors in the U.S. who suffer from post-stroke hand disability. Post-stroke hand disability impairs stroke survivors' abilities and independence with self-care, hygiene, employment, and leisure, frequently resulting in diminished quality of life. Rehabilitation can often be limited, but research suggests that the effects of therapy is improved by the addition of sensory stimulation.

To fully leverage the potential therapeutic benefits of sensory stimulation, we have developed a new stimulation that is imperceptible random-frequency vibration applied to wrist skin. The objective of this study is to determine if this treatment is superior to task-practice alone in improving hand functional recovery, sensorimotor grip control, and neural communication.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Na Jin Seo, PhD
  • Phone Number: 8437920084
  • Email: seon@musc.edu

Study Locations

    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Na Jin Seo, PhD
          • Phone Number: 843-792-0084
          • Email: seon@musc.edu
        • Principal Investigator:
          • Na Jin Seo, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years old or older
  • At least 6 months since stroke
  • Wolf Motor Function Test (WMFT) total average time >10 seconds
  • WFMT hand task average time <120 s

Exclusion Criteria:

  • Currently undergoing other upper limb therapy
  • Change in spasticity medication or upper limb botulinum toxin injection within 3 months prior to or during enrollment
  • Severe spasticity that limits participation in task practice therapy (e.g., Modified Ashworth Scale=4-5)
  • Comorbidity affecting the upper limb function such as complete upper extremity deafferentation, orthopaedic conditions limiting motion, premorbid neurologic conditions, premorbid peripheral neuropathy, compromised skin integrity of the wrist due to burn or long-term use of blood thinners, or significant new neurological symptoms
  • Language barrier or cognitive impairment that precludes following instructions and/or providing consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vibration
The device will deliver imperceptible vibration for the treatment group.
Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.
Sham Comparator: No Vibration
The device will deliver no vibration for the control group.
Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Score of Wolf Motor Function Test (WMFT)
Time Frame: Baseline and 6 weeks
Timed test of upper extremity function with a variety of tasks.
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Score of Box and Blocks Test
Time Frame: Baseline and 6 weeks
Timed test of upper extremity function by moving blocks.
Baseline and 6 weeks
Change in Score of Action Research Arm Test
Time Frame: Baseline and 6 weeks
Timed test of upper extremity function through a variety of tasks.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2020

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 29, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2023

Last Update Submitted That Met QC Criteria

November 17, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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