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Completed

NCT Number: NCT05455970

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

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical medicine and rehabilitation

Bangkok, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rhythmic auditory stimulation (RAS)

Other

A therapeutic application of pulsed rhythmic or musical stimulation in order to improve gait or movement

Primary outcomes

  1. Timed up and go - in children

    Time frame: 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 outcomes

  1. Pediatric Balance Scale

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Effect of Rhythmic Auditory Stimulation on Functional Balance in Children With Cerebral Palsy, A Randomized Control Trial.

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 13, 2022
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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