Long Term Effect of Hyperbaric Oxygen Therapy on Gait and Functional Balance Skills in Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Stride Length (cm)
研究概览
简要总结
Abnormal gait is a common issue in children with CP. As a result of motor weakness and a lack of voluntary motor control. Furthermore, gait in children with cerebral palsy is characterized by a slower walking speed, a shorter stride length, and more time spent in double support. Deficits in postural control constitute a major limitation to the motor development in children with CP. The performance of static and dynamic tasks, such as sitting, standing, and walking, is limited in these children due to postural instability. Postural control deficits in CP are caused by altered sensory processing, motor impairment, and biomechanical alignment, which result in altered neuromuscular responses.
HBO2 therapeutic benefits in CP are attributed to an increase in dissolved oxygen in plasma and tissue, which aids tissue regeneration, So, the purpose of this study was to investigate the long-term effects of hyperbaric oxygen therapy on spatiotemporal gait parameters and functional balance skills in children with CP.
详细描述
This was a randomized clinical trial. Thirty-nine children with spastic cerebral palsy with ages ranging from 5 to 10 years referred from local pediatric rehabilitation centers participated in this study. All children were classified randomly using sealed envelopes into two groups (Control and Study groups). The children in the control group received traditional physical therapy and the study group received the same traditional physical therapy in addition to hyperbaric oxygen therapy. Written informed consent from the child's legal guardian was obtained. The study was authorized by the Ethics Committee for Research at Cairo University in accordance with the ethical standards of the Declaration of Helsinki. PBS was used to assess functional balance and GAITRite was used to assess spatiotemporal gait parameters. Measurements of functional balance and spatiotemporal gait parameters were taken three times: at the start of the intervention, eight weeks later, and six months after cessation of HPO2 therapy to assess the long-term effect.
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)
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medically free by their doctor.
- •being able to tolerate a hyperbaric oxygen hood.
- •being able to blow through a straw, or swallow on command.
- •having spasticity ranging from 1 to 1+ on the Modified Ashworth Scale
- •level I or II on the Gross Motor Function Classification System (GMFCS).
- •being capable of understanding and following instructions
排除标准
- •Previous HBO treatments.
- •botulinum toxin A treatments.
- •thoracic surgery within 6 months.
- •major changes to spasticity medications within 3 months.
- •unstable epilepsy.
- •pulmonary dysfunction.
- •cardiovascular disease
结局指标
主要结局
Stride Length (cm)
时间窗: 6 months
Change of the stride length was measured using GAITRite System
Velocity (cm/s)
时间窗: 6 months
Change of the velocity was measured using GAITRite System
Double leg support (% of gait cycle)
时间窗: 6 months
Change of the double leg support was measured using GAITRite System
Functional Balance skills (score)
时间窗: 6 months
Change of balance scores was measured using pediatric balance scale. PBS collect scores for the 14 tasks assessed. The tasks are scored on a five-point scale (0, 1, 2, 3 or 4), with zero denoting an inability to perform the activity without assistance and four denoting the ability to perform the task with complete independence. Score range from 0 to 56, with higher scores indicating better postural control
次要结局
未报告次要终点
研究者
Mohamed A. Abdel Ghafar
Associate Professor
Batterjee Medical College