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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07200687
Enrollment
18
Registered
2025-10-01
Start date
2025-07-01
Completion date
2025-10-31
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

OTHERMusic therapy

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

OTHERoccupational therapy

standard treatment

Sponsors

Armakola Filomeni
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
10M WALK TESTFrom enrollment to the end of treatment at 6weeksWALKING ABILITY
pediatric balance scaleFrom enrollment to the end of treatment at 6 weeksbalance 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

MeasureTime frameDescription
blood pressureArterial 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
SaO2 oxygen saturationOxygen 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
heart rateHeart 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 sessionphysiological marker
Respiratory RateRespiratory 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 sessionphysiological marker

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026