Sensory Stimulation During CIMT

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Behavioral: Standardized Constraint-Induced Movement Therapy; Behavioral: Placebo (for vibration); Behavioral: Vibration

• Registration Number: NCT03558230
• Lead Sponsor: 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-06-13
• Study First Posted: 2018-06-15
• Study Start: 2018-07-16
• Primary Completion: 2018-10-28
• Study Completion: 2018-10-28
• Status Verified: 2018-11
• Results First Submitted: 2018-11-16
• Results First Submitted QC: 2018-11-16
• Last Update Submitted: 2018-11-16
• Results First Posted: 2019-03-08
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Vibration	Placebo (for 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.
Vibration	Standardized Constraint-Induced Movement Therapy	The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
Vibration	Vibration	The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
No Vibration	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.

Primary Outcome Measures

Name	Time	Method
Feasibility (Total Number of Hours That Participants Wear the Device)	through 5-day study completion.	total number of hours that participants wear the device

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States