Sensory Stimulation During CIMT

November 16, 2018 updated by: Medical University of South Carolina

Sensory Stimulation During Constraint-Induced Movement Therapy

The long-term goal of this project is to assess the impact of the novel sensory stimulation technique in enhancing outcomes of constraint-induced movement therapy (CIMT) in children with cerebral palsy. This is a pilot project.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The stimulation is peripheral sensory stimulation involving application of low-level, random-frequency vibration to the wrist skin. The hypothesis is that improvement in upper extremity function will be greater for the experimental group receiving the stimulation during CIMT compared with the control group who will wear the device with no vibration (placebo). This pilot study is to assess feasibility and safety.

Study Type

Interventional

Enrollment (Actual)

13

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 Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina

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

3 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Between the ages of 3 and 9
  • Have unilateral upper limb motor weakness.
  • Use the affected extremity as a gross assist during play and self-care activities.
  • No significant developmental delays that would limit spontaneous use of the more affected extremity.
  • Be ambulatory for their age and demonstrate intact balance and protective reactions throughout the less involved upper extremity.
  • No other health impairment other than hemiparesis.

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
Experimental: Vibration
The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
Behavioral: Standardized Constraint-Induced Movement Therapy
The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.
Behavioral: Vibration
Vibration applied to the wrist.
Placebo Comparator: No Vibration

The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.

  • The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
Behavioral: Standardized Constraint-Induced Movement Therapy
The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.
Behavioral: Placebo (for vibration)
No vibration applied to the wrist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (Total Number of Hours That Participants Wear the Device)
Time Frame: through 5-day study completion.
total number of hours that participants wear the device
through 5-day study completion.

Collaborators and Investigators

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

Sponsor

Medical University of South Carolina

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)

July 16, 2018

Primary Completion (Actual)

October 28, 2018

Study Completion (Actual)

October 28, 2018

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 8, 2019

Last Update Submitted That Met QC Criteria

November 16, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO74164

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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