Comparision Of The Effectiveness Of Conventional Physiotherapy After Botulinum Toxin Injection In Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- The Gross Motor Function Classification System (GMFCS)
研究概览
简要总结
A total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. Group 1 received conventional physiotherapy and Group 2 received robot-assisted gait training. The treatment period was 30 min/day, five sessions in a week, 15 sessions in total, for both groups. The study population was evaluated using range of joint motion evaluation chart, the Modified Ashworth Scale, The Gross Motor Function Classification System, The Berg Balance Scale, the functional independence measure for children, and the Edinburgh Visual Gait Score
详细描述
A total of 28 patients who were followed-up in our clinic and received botulinum toxin injection of lower extremities in the last month were randomized to two groups in the study. Group 1 received conventional physiotherapy and Group 2 received robot-assisted gait training. The treatment period was 30 min/day, five sessions in a week, 15 sessions in total, for both groups. The study population was evaluated using range of joint motion evaluation chart, the Modified Ashworth Scale, The Gross Motor Function Classification System, The Berg Balance Scale, the functional independence measure for children, and the Edinburgh Visual Gait Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Participant
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 4>, <16 with CP diagnosis
- •Walking diffculties due to the spasticity of lower extremities,
- •Level I-IV on the Gross Motor Function Classification System.
排除标准
- •MAS Level IV spasticity, contractures, or rigidity in the lower extremities,
- •A limb length inequality of >2 cm,
- •Hypotonic CP,
- •Having drug-related refractory epilepsy,
- •Undergoing intrathecal baclofen pump surgery,
- •Surgical interventions in the lower extremities in the last year,
- •Scoliosis angle of >30°,
- •Complicated osteoporosis (nontraumatic fracture...),
- •Cardiovascular instability,
- •GMFCS Level V,
- •Metabolic disorder, genetic disease, neurodegenerative and neuromuscular diseases.
结局指标
主要结局
The Gross Motor Function Classification System (GMFCS)
时间窗: 3 weeks
The Gross Motor Function Classification System or GMFCS is a 5 level clinical classification system that describes the gross motor function of people with cerebral palsy on the basis of self-initiated movement abilities.
The Edinburgh Visual Gait Scale (EVGS)
时间窗: 3 weeks
The Edinburgh visual gait score is an evaluative tool that uses software and video cameras to provide 3D video gait analysis as well as onscreen drawing and measurement tools to evaluate each portion of gait. The software will then generate a EVGS report, with illustrative images from the video if desired, in PDF format.
次要结局
未报告次要终点
研究者
Dr. Ayşe Güç
Kayseri Education and Research State Hospital
Kayseri Education and Research Hospital