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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Rhythmic auditory stimulation (RAS)
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy focused on measuring Cerebral palsy, Rhythmic Auditory Stimulation, Balance

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Physical medicine and rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rhythmic auditory stimulation (RAS) group

Conventional group

Arm Description

Physical therapy including stretching and strengthening exercise and ambulation training with rhythmic auditory stimulation.

Conventional physical therapy including stretching exercise, strengthening exercise and ambulation training.

Outcomes

Primary Outcome Measures

Timed up and go - in children
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.

Secondary Outcome Measures

Pediatric Balance Scale
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.
Gross Motor Function Measure
The tool to evaluate gross motor function in children with cerebral palsy. The score from 0-186. Higher scores mean better outcome.
Gait Velocity
Gait speed used by 10 meter test recorded in Kilometer per hour. Higher timed measure mean better outcome.

Full Information

First Posted
July 10, 2022
Last Updated
July 29, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT05455970
Brief Title
Effect of Rhythmic Auditory Stimulation on Balance in Children With Cerebral Palsy.
Official Title
Effect of Rhythmic Auditory Stimulation on Functional Balance in Children With Cerebral Palsy, A Randomized Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
September 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, Rhythmic Auditory Stimulation, Balance

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rhythmic auditory stimulation (RAS) group
Arm Type
Experimental
Arm Description
Physical therapy including stretching and strengthening exercise and ambulation training with rhythmic auditory stimulation.
Arm Title
Conventional group
Arm Type
No Intervention
Arm Description
Conventional physical therapy including stretching exercise, strengthening exercise and ambulation training.
Intervention Type
Other
Intervention Name(s)
Rhythmic auditory stimulation (RAS)
Intervention Description
A therapeutic application of pulsed rhythmic or musical stimulation in order to improve gait or movement
Primary Outcome Measure Information:
Title
Timed up and go - in children
Description
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.
Time Frame
Change from baseline Timed up and go - in children at after intervention 3 weeks
Secondary Outcome Measure Information:
Title
Pediatric Balance Scale
Description
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.
Time Frame
Change from baseline Pediatric Balance Scale at after intervention 3 weeks
Title
Gross Motor Function Measure
Description
The tool to evaluate gross motor function in children with cerebral palsy. The score from 0-186. Higher scores mean better outcome.
Time Frame
Change from baseline Gross Motor Function Measure at after intervention 3 weeks
Title
Gait Velocity
Description
Gait speed used by 10 meter test recorded in Kilometer per hour. Higher timed measure mean better outcome.
Time Frame
Change from baseline Gait Velocity at after intervention 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Physical medicine and rehabilitation
City
Bangkok
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/17645385/
Description
Effect of rhythmic auditory stimulation on gait performance in children with spastic cerebral palsy
URL
https://pubmed.ncbi.nlm.nih.gov/22308559/
Description
Differential effects of rhythmic auditory stimulation and neurodevelopmental treatment/Bobath on gait patterns in adults with cerebral palsy: a randomized controlled trial
URL
https://pubmed.ncbi.nlm.nih.gov/22142756/
Description
Changes in gait patterns with rhythmic auditory stimulation in adults with cerebral palsy
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8534581/
Description
Effects of the Combination of Music Therapy and Physiotherapy in the Improvement of Motor Function in Cerebral Palsy: A Challenge for Research

Learn more about this trial

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

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