Cerebral Palsy (CP)NCT07200687
Effects of Combined Music Therapy and Occupational Therapy on Motor and Physiological Parameters in Children With Neurological Impairments: A Non-Randomized Controlled Trial
A study testing Music therapy and occupational therapy in people with Cerebral Palsy (CP) and Encephalitis, run by Armakola Filomeni at 1 site in Greece.
Trial summary
This study aims to explore the effects of an occupational therapy program combined with music therapy elements on children 5-12 years old with neurological disorders including those with neurogenic scoliosis. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP), Encephalitis, Brain Tumor (After Recovery)
- What is being tested?
- Music therapy and occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of a neurological condition with established neurological signs (e.g., motor or cognitive impairments)
- Cerebral Palsy (GMFCS levels I-II),
- Brain infections (e.g., encephalitis),
- Brain neoplasms
- Ability to follow simple instructions and participate in an occupational therapy program,
- Medical clearance to participate in physical activity
Who cannot join
- Degenerative neurological diseases,
- Metabolic disorders affecting the nervous system,
- Neuromuscular disorders, including muscular dystrophy and congenital myopathies,
- Peripheral nervous system damage,
- Current use of corticosteroids,
- Botulinum toxin injection within 30 days prior to the intervention program,
- Hearing loss or diagnosed deafness
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to explore the effects of an occupational therapy program combined with music therapy elements on children 5-12 years old with neurological disorders including those with neurogenic scoliosis. Occupational therapy programs typically focus on improving motor and cognitive functions to enhance the child's overall participation and daily functioning. Music has been shown to positively affect brain areas involved in emotions, memory, and language, and may reduce stress and increase feelings of happiness.
The study will measure changes in biological markers such as blood pressure, oxygen saturation, heart rate, and respiratory rate, as well as improvements in functionality for upper limbs but also balance and walking ability after the therapy program. These markers can provide valuable information about the physical health and quality of life of the children, which is currently lacking for the Greek population.
By investigating these biological indicators along with functional outcomes, this research hopes to offer new insights into the benefits of combining music therapy with occupational therapy. This may encourage better engagement from families and support rehabilitation specialists in demonstrating the value of their interventions even before functional improvements become noticeable
- Being tested
- Music therapy, occupational therapy
- Medical subject headings
- Cerebral Palsy, Encephalitis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
this research hopes to offer new insights into the benefits of combining music therapy with occupational therapy.
occupational therapyOther
standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy + Music Therapy (with scoliosis) | Experimental | This arm includes children with neurological conditions and scoliosis who will receive a structured occupational therapy program incorporating music therapy elements Receives: Other: Music therapy; Other: occupational therapy |
| Occupational Therapy | Active comparator | This group includes children with similar neurological conditions and scoliosis who will receive the same occupational therapy program without any music therapy integration. Receives: Other: occupational therapy |
| Occupational Therapy + Music Therapy (no scoliosis) | Experimental | Children with neurological conditions but without scoliosis receive the same occupational therapy program combined with music therapy. This arm allows the evaluation of music therapy's effects in children with neurological conditions independent of spinal deformity Receives: Other: Music therapy; Other: occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
10M WALK TEST
WALKING ABILITY
Measured: From enrollment to the end of treatment at 6weeks
pediatric balance scale
balance Pediatric Balance Scale (PBS) is used, specifically the Greek validated version ("Pediatric Balance Scale - Greek version," PBS-GR), as translated and cross-culturally adapted by Bania et al. (2023). The scale ranges from 0 to 56, with higher scores indicating better balance performance and a better outcome. The PBS-GR has been shown to have high interrater reliability in children with movement impairment
Measured: "From enrollment to the end of treatment at 6 weeks"
Secondary outcomes (4)
blood pressure
PHYSIOLOGICAL BIOMARKERS
Measured: Arterial blood pressure will be measured using an automated electronic sphygmomanometer (mmHg). Measurements will be taken in a seated position after 5 minutes of rest, immediately before and immediately after (45 min) each therapy session.
SaO2 oxygen saturation
physiological marker
Measured: Oxygen saturation will be measured non-invasively using a fingertip pulse oximeter (%). Measurements will be taken in a seated position, after 5 minutes of rest, immediately before and immediately after each (45 min) therapy session.
heart rate
physiological marker
Measured: Heart rate will be measured non-invasively using an electronic sphygmomanometer (beats per minute, bpm). Measurements will be taken in a seated position, after 5 minutes of rest, immediately before and immediately after (45 min)each therapy session
Respiratory Rate
physiological marker
Measured: Respiratory rate will be measured manually by counting visible thoracic movements (breaths per minute) for 60 seconds while the child is in a seated position before and after (45 min) each therapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Jul 2025
- Primary completion30 Sep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armakola Filomeni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Armakola Filomeni, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200687
- Sponsor's protocol ID
- PA.D.A.-AR.PROT: 66741
- Status last verified
- Oct 2025
- First submitted
- 11 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Music Therapy and Occupational Therapy on Motor and Physiological Parameters in Children With Neurological Impairments: A Non-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07200687
- Acronym / sponsor ID
- PA.D.A.-AR.PROT: 66741
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Armakola FilomeniUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 1 Oct 2025 (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.
This study aims to explore the effects of an occupational therapy program combined with music therapy elements on children 5-12 years old with neurological disorders including those with neurogenic scoliosis. Occupational therapy programs typically focus on improving motor and cognitive functions to enhance the child's overall participation and daily functioning. Music has been shown to positively affect brain areas involved in emotions, memory, and language, and may reduce stress and increase feelings of happiness.
The study will measure changes in biological markers such as blood pressure, oxygen saturation, heart rate, and respiratory rate, as well as improvements in functionality for upper limbs but also balance and walking ability after the therapy program. These markers can provide valuable information about the physical health and quality of life of the children, which is currently lacking for the Greek population.
By investigating these biological indicators along with functional outcomes, this research hopes to offer new insights into the benefits of combining music therapy with occupational therapy. This may encourage better engagement from families and support rehabilitation specialists in demonstrating the value of their interventions even before functional improvements become noticeable
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Occupational Therapy + Music Therapy (with scoliosis) | Experimental | Other: Music therapy, Other: occupational therapyThis arm includes children with neurological conditions and scoliosis who will receive a structured occupational therapy program incorporating music therapy elements |
| Occupational Therapy | Active comparator | Other: occupational therapyThis group includes children with similar neurological conditions and scoliosis who will receive the same occupational therapy program without any music therapy integration. |
| Occupational Therapy + Music Therapy (no scoliosis) | Experimental | Other: Music therapy, Other: occupational therapyChildren with neurological conditions but without scoliosis receive the same occupational therapy program combined with music therapy. This arm allows the evaluation of music therapy's effects in children with neurological conditions independent of spinal deformity |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosis of a neurological condition with established neurological signs (e.g., motor or cognitive impairments)
- Cerebral Palsy (GMFCS levels I-II),
- Brain infections (e.g., encephalitis),
- Brain neoplasms
- Ability to follow simple instructions and participate in an occupational therapy program,
Key exclusion criteria (7 listed)
- Degenerative neurological diseases,
- Metabolic disorders affecting the nervous system,
- Neuromuscular disorders, including muscular dystrophy and congenital myopathies,
- Peripheral nervous system damage,
- Current use of corticosteroids,
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 |
|---|---|---|
| Music therapythis research hopes to offer new insights into the benefits of combining music therapy with occupational therapy. | Other | Occupational Therapy + Music Therapy (no scoliosis), Occupational Therapy + Music Therapy (with scoliosis) |
| occupational therapystandard treatment | Other | Occupational Therapy, Occupational Therapy + Music Therapy (no scoliosis), Occupational Therapy + Music Therapy (with scoliosis) |
Primary outcome
10M WALK TEST
Time frame: From enrollment to the end of treatment at 6weeks
WALKING ABILITY
pediatric balance scale
Time frame: "From enrollment to the end of treatment at 6 weeks"
balance Pediatric Balance Scale (PBS) is used, specifically the Greek validated version ("Pediatric Balance Scale - Greek version," PBS-GR), as translated and cross-culturally adapted by Bania et al. (2023). The scale ranges from 0 to 56, with higher scores indicating better balance performance and a better outcome. The PBS-GR has been shown to have high interrater reliability in children with movement impairment
4 secondary outcomes
blood pressure
Time frame: Arterial blood pressure will be measured using an automated electronic sphygmomanometer (mmHg). Measurements will be taken in a seated position after 5 minutes of rest, immediately before and immediately after (45 min) each therapy session.
SaO2 oxygen saturation
Time frame: Oxygen saturation will be measured non-invasively using a fingertip pulse oximeter (%). Measurements will be taken in a seated position, after 5 minutes of rest, immediately before and immediately after each (45 min) therapy session.
heart rate
Time frame: Heart rate will be measured non-invasively using an electronic sphygmomanometer (beats per minute, bpm). Measurements will be taken in a seated position, after 5 minutes of rest, immediately before and immediately after (45 min)each therapy session
Respiratory Rate
Time frame: Respiratory rate will be measured manually by counting visible thoracic movements (breaths per minute) for 60 seconds while the child is in a seated position before and after (45 min) each therapy session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- 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 Music therapy and occupational therapy in people with Cerebral Palsy (CP) and Encephalitis, run by Armakola Filomeni at 1 site in Greece.
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 6 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2025. 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
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?
10M WALK TEST (time frame: From enrollment to the end of treatment at 6weeks). The study lists 2 primary outcomes in all. 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 7 Oct 2025.