Sensory Stimulation During Constraint-Induced Movement Therapy

Sensory Stimulation During CIMT

Sponsors

Lead sponsor: Medical University of South Carolina

Source 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.

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.

Overall Status Completed
Start Date July 16, 2018
Completion Date October 28, 2018
Primary Completion Date October 28, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Feasibility (Total Number of Hours That Participants Wear the Device) through 5-day study completion.
Enrollment 13
Condition
Intervention

Intervention type: Behavioral

Intervention name: Standardized Constraint-Induced Movement Therapy

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: Vibration

Description: Vibration applied to the wrist.

Arm group label: Vibration

Intervention type: Behavioral

Intervention name: Placebo (for vibration)

Description: No vibration applied to the wrist.

Arm group label: No Vibration

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.

Gender: All

Minimum age: 3 Years

Maximum age: 9 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Na Jin Seo, PhD Principal Investigator Medical University of South Carolina
Location
facility
Medical University of South Carolina
Location Countries

United States

Verification Date

November 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Vibration

Arm group type: Experimental

Description: The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.

Arm group label: No Vibration

Arm group type: Placebo Comparator

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking description: A double-blinded stratified randomized controlled trial

Source: ClinicalTrials.gov