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

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 Overview

• Status: Active, not recruiting
• Conditions: Encephalitis; Cerebral Palsy (CP); Brain Tumor (After Recovery)
• Intervention / Treatment: Other: Music therapy; Other: occupational therapy

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece
      • Athens Children's Hospital P.&A. Kiriakou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: Music therapy; this research hopes to offer new insights into the benefits of combining music therapy with occupational therapy.; Other: occupational therapy; standard treatment
Active Comparator: 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.	Other: occupational therapy; standard treatment
Experimental: 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	Other: Music therapy; this research hopes to offer new insights into the benefits of combining music therapy with occupational therapy.; Other: occupational therapy; standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	PHYSIOLOGICAL BIOMARKERS	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	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	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	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

Collaborators and Investigators

• Sponsor: Armakola Filomeni

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 11, 2025
• First Submitted That Met QC Criteria: September 22, 2025
• First Posted (Estimated): October 1, 2025

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Brain Damage, Chronic; Central Nervous System Neoplasms; Cerebral Palsy; Brain Neoplasms; Encephalitis; Therapeutics; Complementary Therapies; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Occupational Therapy; Music Therapy
• Other Study ID Numbers: PA.D.A.-AR.PROT: 66741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No