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Sensory Stimulation During CIMT

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ClinicalTrials.gov Identifier: NCT03558230
Recruitment Status : Completed
First Posted : June 15, 2018
Results First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Behavioral: Standardized Constraint-Induced Movement Therapy Behavioral: Vibration Behavioral: Placebo (for vibration) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A double-blinded stratified randomized controlled trial
Primary Purpose: Treatment
Official Title: Sensory Stimulation During Constraint-Induced Movement Therapy
Actual Study Start Date : July 16, 2018
Actual Primary Completion Date : October 28, 2018
Actual Study Completion Date : October 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cerebral Palsy

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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558230


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Na Jin Seo, PhD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03558230     History of Changes
Other Study ID Numbers: PRO74164
First Posted: June 15, 2018    Key Record Dates
Results First Posted: March 8, 2019
Last Update Posted: March 8, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of South Carolina:
pediatric
hemiplegic
hand function

Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases