Neurophysiological and Functional Effects of Therapeutic Listening on Core Stability, Reaction Timing, and Balance in Children With Diplegic Spastic Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pediatric Balance Scale (PBS) Score
研究概览
简要总结
This study evaluates whether adding Therapeutic Listening to a structured physiotherapy program can improve balance, trunk control, and reaction time in children with spastic diplegic cerebral palsy.
Children with spastic diplegic cerebral palsy may have difficulties with balance, trunk stability, and responding quickly to sensory cues. In this study, children will receive a structured program including core stability, balance, and reaction-time exercises. One group will receive the exercise program alone, while the other group will receive the same program together with Therapeutic Listening delivered through headphones during the exercise sessions.
The study will compare changes in balance, trunk control, and auditory reaction time between the two groups after 8 weeks of treatment. The study aims to determine whether Therapeutic Listening provides additional benefits when combined with conventional physiotherapy.
详细描述
Children with spastic diplegic cerebral palsy commonly experience difficulties with postural control, trunk stability, balance, and timely responses to sensory cues. These impairments may affect their ability to maintain stability, adapt to changes in the environment, and perform functional movements efficiently.
This randomized controlled trial is designed to investigate whether Therapeutic Listening can provide an additional therapeutic benefit when incorporated into a structured physiotherapy program. The study focuses on the potential contribution of auditory-based sensory input to functional motor performance during active rehabilitation.
The study compares a conventional rehabilitation program targeting core stability, balance, and reaction-time abilities with the same program delivered concurrently with Therapeutic Listening. The intervention period is 8 weeks, with treatment sessions provided three times per week.
The study will examine changes in balance, trunk control, and auditory reaction time following the intervention. The overall aim is to determine whether the addition of Therapeutic Listening enhances the effects of structured physiotherapy in children with spastic diplegic cerebral palsy.
The findings may help clarify the potential role of auditory-based sensory input as an adjunct to conventional pediatric physiotherapy and may provide information for future clinical research investigating multimodal rehabilitation approaches for children with cerebral palsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The manuscript specifies that only the outcome assessor was blinded to group allocation, while participants and treating therapists (care providers/investigators) were not blinded due to the nature of the auditory intervention
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of spastic diplegic cerebral palsy. Classified at Gross Motor Function Classification System (GMFCS) levels II or III. Lower-limb spasticity graded 1+ on the Modified Ashworth Scale (MAS). Ability to understand and follow simple verbal instructions. Medically stable condition.
排除标准
- •Severe cognitive impairment interfering with intervention or assessment. Presence of hearing impairment or auditory processing disorders. History of uncontrolled seizures. Recent orthopedic surgery. Botulinum toxin injection received within the past 6 months. Any other medical condition interfering with study intervention or outcome assessment.
研究组 & 干预措施
Group A: Conventional Training
Structured core stability, traditional balance, and reaction-time training (35-50 min/session, 3 sessions/week for 8 weeks)
干预措施: Conventional Training (Other)
Group B: Therapeutic Listening
Auditory-based sensory intervention utilizing electronically modified music tracks (Space, Rhythmic Connections, or Nature Winds) delivered via high-quality stereo headphones. Listening is administered concurrently during the 35-50 minute core stability and balance exercise sessions, 3 times per week for 8 weeks. Track selection is individualized according to each child's sensory-processing profile.
干预措施: Therapeutic Listening (Behavioral)
结局指标
主要结局
Pediatric Balance Scale (PBS) Score
时间窗: Baseline and immediately post-intervention (8 weeks)
Assessment of sitting and standing balance performance. The PBS evaluates 14 balance tasks scored on a 0-4 scale, with total scores ranging from 0 to 56 (higher scores indicate better functional balance and postural control
次要结局
未报告次要终点
研究者
Karim Samy Ibrahim
Lecture of pediatric physical therapy
MTI University