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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05455970
Other study ID # Ramathibodi
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2018
Est. completion date September 19, 2019

Study information

Verified date July 2022
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date September 19, 2019
Est. primary completion date September 20, 2018
Accepts healthy volunteers No
Gender All
Age group 7 Years to 15 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Rhythmic auditory stimulation (RAS)
A therapeutic application of pulsed rhythmic or musical stimulation in order to improve gait or movement

Locations

Country Name City State
Thailand Physical medicine and rehabilitation Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Change from baseline Pediatric Balance Scale at after intervention 3 weeks
Secondary 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. Change from baseline Gross Motor Function Measure at after intervention 3 weeks
Secondary Gait Velocity 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
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