Sensory Stimulation During CIMT

NCT ID: NCT03558230

Last Updated: 2019-03-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2018-10-28

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
A double-blinded stratified randomized controlled trial

Study Groups

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Vibration

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

Group Type EXPERIMENTAL

Standardized Constraint-Induced Movement Therapy

Intervention Type BEHAVIORAL

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.

Vibration

Intervention Type BEHAVIORAL

Vibration applied to the wrist.

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.

Group Type PLACEBO_COMPARATOR

Standardized Constraint-Induced Movement Therapy

Intervention Type BEHAVIORAL

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.

Placebo (for vibration)

Intervention Type BEHAVIORAL

No vibration applied to the wrist.

Interventions

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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.

Intervention Type BEHAVIORAL

Vibration

Vibration applied to the wrist.

Intervention Type BEHAVIORAL

Placebo (for vibration)

No vibration applied to the wrist.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Na Jin Seo, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PRO74164

Identifier Type: -

Identifier Source: org_study_id

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