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Active, Not Recruiting

NCT Number: NCT07200687

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Brain Neoplasms Brain Tumor (After Recovery) Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Palsy Encephalitis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neuroinflammatory Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athens Children's Hospital P.&A. Kiriakou

Athens, Attica, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Therapy

Other

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

Occupational Therapy

Other

standard treatment

Primary outcomes

  1. 10M WALK TEST

    Time frame: From enrollment to the end of treatment at 6weeks

    WALKING ABILITY

  2. 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

Secondary outcomes

  1. 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.

    PHYSIOLOGICAL BIOMARKERS

  2. 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.

    physiological marker

  3. 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

    physiological marker

  4. 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

    physiological marker

Sponsors and collaborators

Lead sponsor

Armakola Filomeni

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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