Effects of Combined Music Therapy and Occupational Therapy on Motor and Physiological Parameters in Children With Neurological Impairments: A Non-Randomized Controlled Trial

NCT ID: NCT07200687

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-10-31

Brief 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. 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

Conditions

Cerebral Palsy (CP); Encephalitis; Brain Tumor (After Recovery)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Occupational Therapy + Music Therapy (with scoliosis)

This arm includes children with neurological conditions and scoliosis who will receive a structured occupational therapy program incorporating music therapy elements

Group Type: EXPERIMENTAL

Music therapy

Intervention Type: OTHER

this research hopes to offer new insights into the benefits of combining music therapy with occupational therapy.

occupational therapy

Intervention Type: OTHER

standard treatment

Occupational Therapy

This group includes children with similar neurological conditions and scoliosis who will receive the same occupational therapy program without any music therapy integration.

Group Type: ACTIVE_COMPARATOR

occupational therapy

Intervention Type: OTHER

standard treatment

Occupational Therapy + Music Therapy (no scoliosis)

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

Group Type: EXPERIMENTAL

Music therapy

Intervention Type: OTHER

this research hopes to offer new insights into the benefits of combining music therapy with occupational therapy.

occupational therapy

Intervention Type: OTHER

standard treatment

Interventions

Music therapy

this research hopes to offer new insights into the benefits of combining music therapy with occupational therapy.

Intervention Type: OTHER

occupational therapy

standard treatment

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Armakola Filomeni

OTHER

Sponsor Role: lead

Responsible Party

Armakola Filomeni

MD, MSc, PhDc

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Athens Children's Hospital P.&A. Kiriakou

Athens, Attica, Greece

Countries

Greece

Other Identifiers

PA.D.A.-AR.PROT: 66741

Identifier Type: -

Identifier Source: org_study_id