Cerebral PalsyNCT05455970
Effect of Rhythmic Auditory Stimulation on Balance in Children With Cerebral Palsy.
A study testing Rhythmic auditory stimulation (RAS) in people with Cerebral Palsy, run by Mahidol University at 1 site in Thailand.
Trial summary
To evaluate the effect of Rhythmic Auditory Stimulation (RAS) on balance in children with cerebral palsy. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Rhythmic auditory stimulation (RAS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteThailand
- Study dates
- 20 Sep 2018to 19 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with cerebral palsy at 7-15 years old with Gross motor function classification system 1-3.
- Patients can understand and follow to command.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rhythmic Auditory Stimulation on Functional Balance in Children With Cerebral Palsy, A Randomized Control Trial.
To evaluate the effect of Rhythmic Auditory Stimulation (RAS) on balance in children with cerebral palsy.
- Conditions
- Cerebral Palsy
- Being tested
- Rhythmic auditory stimulation (RAS)
- Keywords
- Cerebral palsy, Rhythmic Auditory Stimulation, Balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic auditory stimulation (RAS)Other
A therapeutic application of pulsed rhythmic or musical stimulation in order to improve gait or movement
| Study group | Role | What they receive |
|---|---|---|
| Rhythmic auditory stimulation (RAS) group | Experimental | Physical therapy including stretching and strengthening exercise and ambulation training with rhythmic auditory stimulation. Receives: Other: Rhythmic auditory stimulation (RAS) |
| Conventional group | No intervention | Conventional physical therapy including stretching exercise, strengthening exercise and ambulation training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline Timed up and go - in children at after intervention 3 weeks
Secondary outcomes (3)
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.
Measured: Change from baseline Pediatric Balance Scale at after intervention 3 weeks
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.
Measured: Change from baseline Gross Motor Function Measure at after intervention 3 weeks
Gait Velocity
Gait speed used by 10 meter test recorded in Kilometer per hour. Higher timed measure mean better outcome.
Measured: Change from baseline Gait Velocity at after intervention 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start20 Sep 2018
- Primary completion20 Sep 2018
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Apiphan Iamchaimongkol, MD, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455970
- Sponsor's protocol ID
- Ramathibodi
- Status last verified
- Jul 2022
- First submitted
- 10 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rhythmic Auditory Stimulation on Functional Balance in Children With Cerebral Palsy, A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05455970
- Acronym / sponsor ID
- Ramathibodi
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, Rhythmic Auditory Stimulation, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of Rhythmic Auditory Stimulation (RAS) on balance in children with cerebral palsy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhythmic auditory stimulation (RAS) group | Experimental | Other: Rhythmic auditory stimulation (RAS)Physical therapy including stretching and strengthening exercise and ambulation training with rhythmic auditory stimulation. |
| Conventional group | No intervention | –Conventional physical therapy including stretching exercise, strengthening exercise and ambulation training. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients with cerebral palsy at 7-15 years old with Gross motor function classification system 1-3.
- Patients can understand and follow to command.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythmic auditory stimulation (RAS)A therapeutic application of pulsed rhythmic or musical stimulation in order to improve gait or movement | Other | Rhythmic auditory stimulation (RAS) group |
Primary outcome
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.
3 secondary outcomes
Pediatric Balance Scale
Time frame: Change from baseline Pediatric Balance Scale at after intervention 3 weeks
Gross Motor Function Measure
Time frame: Change from baseline Gross Motor Function Measure at after intervention 3 weeks
Gait Velocity
Time frame: Change from baseline Gait Velocity at after intervention 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Effect of rhythmic auditory stimulation on gait performance in children with spastic cerebral palsyLink provided by the sponsor.
- Differential effects of rhythmic auditory stimulation and neurodevelopmental treatment/Bobath on gait patterns in adults with cerebral palsy: a randomized controlled trialLink provided by the sponsor.
- Changes in gait patterns with rhythmic auditory stimulation in adults with cerebral palsyLink provided by the sponsor.
- Effects of the Combination of Music Therapy and Physiotherapy in the Improvement of Motor Function in Cerebral Palsy: A Challenge for ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic auditory stimulation (RAS) in people with Cerebral Palsy, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed up and go - in children (time frame: Change from baseline Timed up and go - in children at after intervention 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.