Effect of Rhythmic Auditory Stimulation on Balance in Children With Cerebral Palsy.

July 29, 2022 updated by: Apiphan Iamchaimongkol, MD, Mahidol University

Effect of Rhythmic Auditory Stimulation on Functional Balance in Children With Cerebral Palsy, A Randomized Control Trial.

To evaluate the effect of Rhythmic Auditory Stimulation (RAS) on balance in children with cerebral palsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Physical Medicine and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with cerebral palsy at 7-15 years old with Gross motor function classification system 1-3.
  • Patients can understand and follow to command.

Exclusion Criteria:

  • Patients who received surgery/chemo-denervation injection/injury at spine/pelvic/lower extremities in last 6 months.
  • Patients with intrathecal baclofen pump implantation.
  • Patients with other signs and/or symptoms of neurological deficit that effect ability to ambulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rhythmic auditory stimulation (RAS) group
Physical therapy including stretching and strengthening exercise and ambulation training with rhythmic auditory stimulation.
Other: Rhythmic auditory stimulation (RAS)
A therapeutic application of pulsed rhythmic or musical stimulation in order to improve gait or movement
NO_INTERVENTION: Conventional group
Conventional physical therapy including stretching exercise, strengthening exercise and ambulation training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed up and go - in children
Time Frame: Change from baseline Timed up and go - in children at after intervention 3 weeks
The tool to assess functional mobility in pediatric population. This is a timed measure during which the child has to stand up from a chair, walk 3 m, turn around, walk back, and sit down. Higher timed measure mean worse outcome.
Change from baseline Timed up and go - in children at after intervention 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Balance Scale
Time Frame: Change from baseline Pediatric Balance Scale at after intervention 3 weeks
A modified version of the Berg Balance Scale from 0-56. That is used to assess functional balance skills in children. Higher scores mean better outcome.
Change from baseline Pediatric Balance Scale at after intervention 3 weeks
Gross Motor Function Measure
Time Frame: Change from baseline Gross Motor Function Measure at after intervention 3 weeks
The tool to evaluate gross motor function in children with cerebral palsy. The score from 0-186. Higher scores mean better outcome.
Change from baseline Gross Motor Function Measure at after intervention 3 weeks
Gait Velocity
Time Frame: Change from baseline Gait Velocity at after intervention 3 weeks
Gait speed used by 10 meter test recorded in Kilometer per hour. Higher timed measure mean better outcome.
Change from baseline Gait Velocity at after intervention 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 20, 2018

Primary Completion (ACTUAL)

September 20, 2018

Study Completion (ACTUAL)

September 19, 2019

Study Registration Dates

First Submitted

July 10, 2022

First Submitted That Met QC Criteria

July 10, 2022

First Posted (ACTUAL)

July 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2022

Last Update Submitted That Met QC Criteria

July 29, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ramathibodi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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