NCT05455970

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

Same day

First QC Date

July 10, 2022

Last Update Submit

July 29, 2022

Conditions

Keywords

Cerebral palsy, Rhythmic Auditory Stimulation, Balance

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

EXPERIMENTAL

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

Other: Rhythmic auditory stimulation (RAS)

Conventional group

NO INTERVENTION

Conventional 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

Rhythmic auditory stimulation (RAS) group

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

Related Links

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

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

Locations