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

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05455970
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 12
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Other: Rhythmic auditory stimulation (RAS)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effect of Rhythmic Auditory Stimulation on Functional Balance in Children With Cerebral Palsy, A Randomized Control Trial.
• Actual Study Start Date: Sep 20, 2018
• Actual Primary Completion Date: Sep 20, 2018
• Actual Study Completion Date: Sep 19, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Timed up and go - in children [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.

Secondary Outcome Measures

1. Pediatric Balance Scale [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.

2. Gross Motor Function Measure [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.

3. Gait Velocity [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physical medicine and rehabilitation	Bangkok		Thailand

Sponsors and Collaborators

• Mahidol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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

Publications

None provided.

• Responsible Party: Apiphan Iamchaimongkol, MD, Principal Investigator, Mahidol University
• ClinicalTrials.gov Identifier: NCT05455970
• Other Study ID Numbers: Ramathibodi
• First Posted: Jul 13, 2022
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Apiphan Iamchaimongkol, MD, Principal Investigator, Mahidol University: Cerebral palsy, Rhythmic Auditory Stimulation, Balance
• Additional relevant MeSH terms: Paralysis; Cerebral Palsy

Study Results

No Results Posted as of Aug 2, 2022