Vibrotactile Stimulation for Upper-Extremity Stroke Rehabilitation

April 9, 2024 updated by: University of Colorado, Denver

Vibrotactile Stimulation for Neurological Disorders

The goal of this clinical trial is to investigate upper-extremity vibrotactile stimulation with wearables in stroke patients. The main questions it aims to answer are:

Are the wearables well-tolerated by patients? Does the vibrotactile stimulation help regain arm function?

Participants will wear vibrotactile stimulation gloves and shirts for 5 hours daily during their stay at the rehabilitation unit, in addition to conventional therapy. Researchers will compare the treatment group (vibrotactile stimulation wearables) with a control group (conventional therapy only) to see the effects of the vibrotactile stimulation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

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

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Broomfield, Colorado, United States, 80021

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inpatients at rehabilitation units
  • Unilateral left or right sided ischemic stroke within the previous 2 weeks
  • Have Upper-Extremity Fugl-Meyer scores between 6 and 58
  • Have at least 20 degrees of active shoulder elevation and elbow flexion
  • Expected to stay 1-3 weeks in the rehabilitation unit

Exclusion Criteria:

  • Under anti-spasticity therapy
  • Patients that are dependent on pacemakers
  • Patients that have defibrillators
  • Have lymphedema or AV fistula for dialysis on an arm

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vibrotactile Stimulation
Participants wear vibrotactile stimulation shirts and gloves for 5 hours per day, 7 days per week, during their stay at the rehabilitation unit, which is expected to be between 2-3 weeks. Participants wear the devices after conventional therapy is done for the day.
Device: Vibrotactile Stimulation
Shirts contain embedded vibration motors that stimulate the impaired upper-extremity at 18 different locations. The gloves stimulates the fingertips.
No Intervention: Control
Participants undergo conventional therapy only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fugl-Meyer Test of Sensorimotor Function After Stroke (UEFM)
Time Frame: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
An impairment based measure consisting of 33 movements that tests motor and sensation of the affected arm. Higher scores indicate less impairment and more isolated motions. Scores are between 0 and 66.
Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with at least one adverse event
Time Frame: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Adverse event will only include those that are determined to be related to the vibrotactile stimulation
End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Number of participants who completed the therapy
Time Frame: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Vibrotactile stimulation therapy feasibility will be assessed by the number of participants who completed the therapy
End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Number of participants who tolerated the vibrotactile stimulation therapy
Time Frame: End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Therapy tolerability will be assessed by responses to questionnaires
End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
Change in the modified Ashworth scale
Time Frame: Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).
The modified Ashworth scale is used to assess spasticity and tests the resistance to passive movement about a joint with varying degree of velocity. The modified Ashworth scale assigns a grade of spasticity from a 0-4 ordinal scale
Baseline, End of the study (approximately 1-3 weeks, at discharge from the rehabilitation unit).

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

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)

February 2, 2024

Primary Completion (Estimated)

February 2, 2025

Study Completion (Estimated)

February 2, 2025

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0783

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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