Spinal Mobility in Children With Cerebral Palsy Undergoing NDT-Bobath Therapy and Exergaming-based Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Cervical Spine Mobility
研究概览
简要总结
The purpose of this study is to evaluate changes in spinal mobility in the cervical, thoracic, and lumbar regions in children with cerebral palsy aged 10-15 years. The study will compare outcomes between standard NDT-Bobath therapy supplemented with exergaming in a sitting position and exergaming in a standing position. Postural stability, body composition, and functional parameters will also be assessed.
Participants will complete a socio-medical questionnaire and undergo baseline measurements of spinal mobility, cervical range of motion, postural stability (using Podoscan and Zebris platform), body height, and body composition (using SECA stadiometer and Tanita bioimpedance analyzer).
The intervention will last 3 months and include twice-weekly 60-minute therapy sessions. Group I will receive NDT-Bobath therapy supplemented with exergaming in a sitting position, while Group II will receive NDT-Bobath therapy with exergaming in a standing position.
After the intervention, participants will undergo post-intervention measurements and a follow-up evaluation three months later to assess the persistence of any changes.
详细描述
This study aims to evaluate the effects of NDT-Bobath therapy supplemented with exergaming on spinal mobility in children with cerebral palsy (CP) aged 10-15 years. Based on these calculations, a representative study sample includes 42 participants.
Eligible participants are children diagnosed by a physician with spastic diplegia (G80.1) or spastic hemiplegia (G80.2), the two most common clinical phenotypes of CP, representing approximately 35% and 25% of cases, respectively. Participants will be randomly assigned to two intervention groups:
Group I: NDT-Bobath therapy supplemented with exergaming performed in a sitting position.
Group II: NDT-Bobath therapy supplemented with exergaming performed in a standing position.
Participants' data will only be included in the final analysis if their attendance at therapy sessions is at least 85%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from parents/guardians and the child (if capable)
- •GMFCS levels I-III (mild to moderate motor limitations)
- •Ability to maintain standing position
- •Ability to follow instructions and perform exercises
- •No prior exergaming therapy
- •No implanted electronic devices
- •No acute infections or inflammatory conditions
- •No metabolic disorders affecting bioimpedance measurements
排除标准
- •GMFCS levels IV-V
- •Orthopedic surgery within the past 12 months
- •Seizure episodes within the past 6 months
- •Cognitive or behavioral impairments preventing cooperation
- •Severe spinal deformities (scoliosis >40° or other significant changes)
- •Attendance at therapy sessions <85%
研究组 & 干预措施
NDT-Bobath + Sitting Exergaming
Participants in this group will receive standard NDT-Bobath therapy supplemented with exergaming performed in a seated position. Therapy sessions will last 60 minutes, twice weekly, for 3 months.
The NDT-Bobath component focuses on:
Normalizing muscle tone in the pelvic and shoulder girdle Enhancing central trunk stability, including trunk rotation Promoting symmetrical posture and controlled movement according to NDT principles (facilitation, stimulation, communication)
The exergaming component will be performed while seated on a chair with adjustable height to achieve 90° flexion at hips, knees, and ankles. Exercises will engage three-dimensional trunk and limb movements, be visually engaging, and allow personalization according to each child's functional level. Exercises are safe, non-impact, and synchronized with the MyoMotion system for monitoring.
干预措施: NDT-Bobath Therapy (Other)
NDT-Bobath + Sitting Exergaming
Participants in this group will receive standard NDT-Bobath therapy supplemented with exergaming performed in a seated position. Therapy sessions will last 60 minutes, twice weekly, for 3 months.
The NDT-Bobath component focuses on:
Normalizing muscle tone in the pelvic and shoulder girdle Enhancing central trunk stability, including trunk rotation Promoting symmetrical posture and controlled movement according to NDT principles (facilitation, stimulation, communication)
The exergaming component will be performed while seated on a chair with adjustable height to achieve 90° flexion at hips, knees, and ankles. Exercises will engage three-dimensional trunk and limb movements, be visually engaging, and allow personalization according to each child's functional level. Exercises are safe, non-impact, and synchronized with the MyoMotion system for monitoring.
干预措施: Sitting Exergaming (Other)
NDT-Bobath + Standing Exergaming
Participants in this group will receive standard NDT-Bobath therapy supplemented with exergaming performed in a standing position. Therapy sessions will last 60 minutes, twice weekly, for 3 months.
The NDT-Bobath component focuses on:
Normalizing muscle tone in the pelvic and shoulder girdle Enhancing central trunk stability, including trunk rotation Promoting symmetrical posture and controlled movement according to NDT principles (facilitation, stimulation, communication)
The exergaming component will be performed in a standing position, promoting weight-bearing and functional trunk and limb control. Exercises engage three-dimensional movements, are visually appealing, and personalized according to the child's functional abilities. Exercise intensity is safe and designed to prevent injury, with position adjustments between exercises as needed. Exercises are synchronized with the MyoMotion system for real-time monitoring.
干预措施: NDT-Bobath Therapy (Other)
NDT-Bobath + Standing Exergaming
Participants in this group will receive standard NDT-Bobath therapy supplemented with exergaming performed in a standing position. Therapy sessions will last 60 minutes, twice weekly, for 3 months.
The NDT-Bobath component focuses on:
Normalizing muscle tone in the pelvic and shoulder girdle Enhancing central trunk stability, including trunk rotation Promoting symmetrical posture and controlled movement according to NDT principles (facilitation, stimulation, communication)
The exergaming component will be performed in a standing position, promoting weight-bearing and functional trunk and limb control. Exercises engage three-dimensional movements, are visually appealing, and personalized according to the child's functional abilities. Exercise intensity is safe and designed to prevent injury, with position adjustments between exercises as needed. Exercises are synchronized with the MyoMotion system for real-time monitoring.
干预措施: Standing Exergaming (Other)
结局指标
主要结局
Cervical Spine Mobility
时间窗: Baseline, post-intervention (3 months), follow-up (6 months)
Change in active cervical spine range of motion in children with cerebral palsy aged 10-15 years, measured in sagittal, frontal, and transverse planes using the CROM device. Cervical flexion/extension, lateral flexion, and rotation are expressed in degrees.
Thoracic Spine Mobility
时间窗: Baseline, post-intervention (3 months), follow-up (6 months)
Change in thoracic spine mobility measured as active range of motion and trunk rotation using the MyoMotion system. Measurements are expressed in degrees and reflect thoracic flexion/extension, lateral flexion, and rotational movements.
Lumbar Spine Mobility
时间窗: Baseline, post-intervention (3 months), follow-up (6 months)
Change in lumbar spine mobility measured as active range of motion using the MyoMotion system. Lumbar flexion/extension, lateral flexion, and rotation are expressed in degrees.
次要结局
未报告次要终点
研究者
Aleksandra Kopaczyńska
Principal Investigator
Wroclaw University of Health and Sport Sciences