The Efficacy of a Robotic-assisted Gait Training in Comparison to Body Weight Supported Treadmill Training on Spatio-temporal Gait Parameters Among Ambulatory Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Gait spatio-temporal parameters
研究概览
简要总结
This study compared the effects of Robotic-assisted Gait Training (RAGT) and body weight support treadmill training (BWSTT) on spatio-temporal gait parameters and walking capacity among ambulatory children with bilateral Cerebral Palsy (CP)
详细描述
Demographic data were collected from patient medical records in the physiotherapy clinic at King Abdullah Specialist Children's Hospital and by completing the screening sheet . There were two intervention groups in this study. The first group received Robotic-assisted Gait Training (RAGT), while the second group received body weight support treadmill training (BWSTT). All participants from both intervention groups performed the home exercise program. All participants received 24 sessions three times per week over 8 weeks. Some participants were absent from some treatment sessions, either because they were suffering from flu, for reasons related to school, or other reasons. These participants were compensated with other sessions. Outcome measurements were assessed by a physiotherapist blinded to the group allocations. A physiotherapist assessed the participants at baseline and after treatment (at the end of 8 weeks)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged from 5 to 14 years with bilateral spastic Cerebral palsy (CP) diagnosed by a pediatrician.
- •Gross Motor Function Classifications (GMFCS); levels I (walks without limitation), II (walks with limitation), and III (walks using assistive devices).
- •Able to follow instructions and accurately signal pain and discomfort.
- •Hip and knee passive Range of Motion (ROM) within the minimum range requirement for Robotic-assisted Gait Training (RAGT) (≤ 10⁰ for hip and knee flexion contracture and ≤ 40⁰ for knee valgus).
排除标准
- •Botox injection for lower limb within the past 4 to 6 months.
- •Surgical intervention for lower limbs within an 8-month period before the examination date, including tendon release and muscle lengthening in a 1-year period prior to bone surgery.
- •Children using an active drug for resisting epilepsy.
- •Anatomical leg length difference greater than 2 centimeters (due to the limitations of the RAGT system).
- •Bone-articular instability (joint dislocation).
- •Fixed joint contractures (bone and joint deformity).
- •Baclofen therapy with the use of an implanted infusion pump.
- •Inhibited cast for a lower limb within 6 months of the study.
- •Significant amblyopia and hearing loss.
- •Skin inflammation and open skin lesion around the limb or trunk.
- •Significant impairments in endurance due to a limitation in the cardiovascular system based on the patient's history.
- •Maximum child weight is 135 kilograms and maximum height is 2.0 meters.
结局指标
主要结局
Gait spatio-temporal parameters
时间窗: 1 minute
The Zebris gait analysis system was used in this study to obtain gait spatio-temporal parameters in children with CP. The Zebris gait analysis system consists of a platform that has a sensing area of 200 × 60 cm.
次要结局
- Six-minute walk test (6MWT)(6 minutes)
研究者
Jaber Mohammed Ali Fagehi
Principal Investigator
King Saud University