Effect of Rhythmic Auditory Stimulation on Balance in Children With Cerebral Palsy.
1 other identifier
interventional
22
1 country
1
Brief Summary
To evaluate the effect of Rhythmic Auditory Stimulation (RAS) on balance in children with cerebral palsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2019
CompletedFirst Submitted
Initial submission to the registry
July 10, 2022
CompletedFirst Posted
Study publicly available on registry
July 13, 2022
CompletedAugust 2, 2022
July 1, 2022
Same day
July 10, 2022
July 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Change from baseline Timed up and go - in children at after intervention 3 weeks
Secondary Outcomes (3)
Pediatric Balance Scale
Change from baseline Pediatric Balance Scale at after intervention 3 weeks
Gross Motor Function Measure
Change from baseline Gross Motor Function Measure at after intervention 3 weeks
Gait Velocity
Change from baseline Gait Velocity at after intervention 3 weeks
Study Arms (2)
Rhythmic auditory stimulation (RAS) group
EXPERIMENTALPhysical therapy including stretching and strengthening exercise and ambulation training with rhythmic auditory stimulation.
Conventional group
NO INTERVENTIONConventional physical therapy including stretching exercise, strengthening exercise and ambulation training.
Interventions
A therapeutic application of pulsed rhythmic or musical stimulation in order to improve gait or movement
Eligibility Criteria
You may qualify if:
- Patients with cerebral palsy at 7-15 years old with Gross motor function classification system 1-3.
- Patients can understand and follow to command.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Physical medicine and rehabilitation
Bangkok, Thailand
Related Links
- Effect of rhythmic auditory stimulation on gait performance in children with spastic cerebral palsy
- Differential effects of rhythmic auditory stimulation and neurodevelopmental treatment/Bobath on gait patterns in adults with cerebral palsy: a randomized controlled trial
- Changes in gait patterns with rhythmic auditory stimulation in adults with cerebral palsy
- Effects of the Combination of Music Therapy and Physiotherapy in the Improvement of Motor Function in Cerebral Palsy: A Challenge for Research
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 10, 2022
First Posted
July 13, 2022
Study Start
September 20, 2018
Primary Completion
September 20, 2018
Study Completion
September 19, 2019
Last Updated
August 2, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share