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

NCT07200687 | Active Not Recruiting DMC

• 1 other identifier: PA.D.A.-AR.PROT: 66741
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• 10M WALK TEST

  WALKING ABILITY

  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

  "From enrollment to the end of treatment at 6 weeks"

Secondary Outcomes (4)

• blood pressure

  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

  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

  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

  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

Study Arms (3)

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

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.

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

Other: Music therapy; Other: occupational therapy

Interventions

Music therapy OTHER

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

Occupational Therapy + Music Therapy (no scoliosis); Occupational Therapy + Music Therapy (with scoliosis)

occupational therapy OTHER

standard treatment

Occupational Therapy; Occupational Therapy + Music Therapy (no scoliosis); Occupational Therapy + Music Therapy (with scoliosis)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Armakola Filomeni: lead

Study Sites (1)

Athens Children's Hospital P.&A. Kiriakou

Athens, Attica, Greece

Location

MeSH Terms

Conditions

Cerebral Palsy; Encephalitis; Brain Neoplasms

Interventions

Music Therapy; Occupational Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MSc, PhDc

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: October 1, 2025
• Study Start: July 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: October 1, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)