Back to resultsSensory Stimulation During CIMT
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standardized Constraint-Induced Movement Therapy
Vibration
Placebo (for vibration)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring pediatric, hemiplegic, hand function
Eligibility Criteria
- 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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vibration
No Vibration
Arm Description
The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
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.
Outcomes
Primary Outcome Measures
Feasibility (Total Number of Hours That Participants Wear the Device)
total number of hours that participants wear the device
Secondary Outcome Measures
Full Information
NCT ID
NCT03558230
First Posted
May 7, 2018
Last Updated
November 16, 2018
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT03558230
Brief Title
Sensory Stimulation During CIMT
Official Title
Sensory Stimulation During Constraint-Induced Movement Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
October 28, 2018 (Actual)
Study Completion Date
October 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
pediatric, hemiplegic, hand function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A double-blinded stratified randomized controlled trial
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vibration
Arm Type
Experimental
Arm Description
The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
Arm Title
No Vibration
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardized Constraint-Induced Movement Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vibration
Intervention Description
Vibration applied to the wrist.
Intervention Type
Behavioral
Intervention Name(s)
Placebo (for vibration)
Intervention Description
No vibration applied to the wrist.
Primary Outcome Measure Information:
Title
Feasibility (Total Number of Hours That Participants Wear the Device)
Description
total number of hours that participants wear the device
Time Frame
through 5-day study completion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Na Jin Seo, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Sensory Stimulation During CIMT
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