Effects of Combined Music Therapy and Occupational Therapy on Motor and Physiological Parameters in Children With Neurological Impairments: A Non-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- pediatric balance scale
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Music therapy (Other)
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
干预措施: occupational therapy (Other)
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.
干预措施: occupational therapy (Other)
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
干预措施: Music therapy (Other)
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
干预措施: occupational therapy (Other)
结局指标
主要结局
pediatric balance scale
时间窗: "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
10M WALK TEST
时间窗: From enrollment to the end of treatment at 6weeks
WALKING ABILITY
10M WALK TEST
时间窗: From enrollment to the end of treatment at 6weeks
WALKING ABILITY
pediatric balance scale
时间窗: "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
次要结局
- 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)
研究者
Armakola Filomeni
MD, MSc, PhDc
University of West Attica