Investıgatıon of the Effect of Hıppotherapy Sımulator on Lower Extremıty Selectıve Motor Control, Balance and Trunk Control in Chıldren Wıth Spastıc Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Manuel ability classification system (MACS)
研究概览
简要总结
The horseback riding simulator (HRS) is a dynamic robotic device that mimics the movement of a horse for hippotherapy purposes. HRS aims to improve the patient's balance, adaptation and provide postural adjustment by mimicking the rhythmic movements of the horse.
This study aims to research the potential benefits of the horseback riding simulator on the lower extremity selective motor control, balance and trunk control in children with Cerebral palsy.
详细描述
Between the dates of the study, children with Cerebral palsy (CP) who meet the inclusion criteria will be allocated into two groups (intervention group, control group) by randomiZation method.
Intervention group: horseback riding simulator (HRS) will be applied in addition to routine Physiotherapy and Rehabilitation. This group will receive 20 minutes of routine physiotherapy training and 20 minutes of HRS application in addition to 2 sessions per week for 8 weeks.
Control group: Routine physiotherapy training will be applied within a specific programme for 40 minutes in 2 sessions per week for 8 weeks.
All the assessments will be performed before and after the training in the 8-week groups.
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
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Spastic Cerebral Palsy
- •Voluntary participation
- •Age between 5-17 years,
- •GMFCS Level I-II-III
- •MACS Level I-II-III
- •Modified Asworth Scale (MAS) Level 1-2-3
- •Have the ability to sit with support
排除标准
- •Having severe visual and hearing problems
- •Severe distractibility problems and inability to follow task instructions,
- •Not voluntary to participate in the research,
- •Individuals with CP who have had hip or spine surgery in the last 6 months
- •Individuals with CP who have undergone Botox in the last 6 months
结局指标
主要结局
Manuel ability classification system (MACS)
时间窗: At Baseline
Classify how children with CP use their hands when dealing with objects in daily activities. It is a 5-level classification scale. The higher the level, the worse the manual ability. Level 1 means that objects can be handled and used easily and successfully. Level 5 refers to being unable to handle and use objects and having severely limited ability to perform even simple activities.
Change from Baseline Trunk Control Measurement Scale at 8 weeks
时间窗: Change from Baseline at 8 weeks
This scale consists of two main parts, dynamic and static sitting balance, and provides an assessment. The scale consists of 15 items. Items are scored as 0, 1, 2 or 3. The minimum score that can be obtained from the scale is 0 and the maximum score is 58. A higher score indicates better trunk control.
Change from Baseline Modified Ashworth Scale (MAS) at 8 weeks
时间窗: Change from Baseline at 8 weeks
This scale is the most widely used clinical scale to assess spasticity. It is a 6-point scale that assesses muscle tone by passively moving the joint through the normal range of possible motion and recording resistance to passive movement. The scoring ranges from 0-5. There is no tonus increase at 0. 5 indicates that the affected limb is rigid. The higher the score, the greater the increase in tonus.
Gross Motor Function Classification System (GMFCS)
时间窗: At Baseline
Assessing functional level and gross motor function of children with CP. Level I refers to a child walking independently, while level V refers to mobility with a wheelchair.
Change from Baseline Selective Control Assessment of the Lower Extremity at 8 weeks
时间窗: Change from Baseline at 8 weeks
Evaluates the lower extremity selective motor control of individuals with CP. The scale assesses five joints separately and bilaterally: hip, knee, ankle, subtalar joint and toe. The degree of selective motor control is determined for each joint as 'normal' (2 points), 'impaired' (1 point) or 'unable to perform' (0 points), according to the patient's ability to perform the movements. The total score is obtained by summing the scores from the joint levels for each limb, with a maximum score of 10 points. Low scores indicate poor selective motor control.
Change from Baseline Pediatric balance scale at 8 weeks
时间窗: Change from Baseline at 8 weeks
Assesses the balance of children with CP. This scale consists of 14 items, each of which is scored from 0 to 4. A score of 0 indicates that he/she cannot carry out the instruction and a score of 4 indicates that he/she can do it without difficulty. The total score ranges from 0-56. A low total score indicates a decrease in balance function.
次要结局
未报告次要终点
研究者
Yalcın KARABULUT
Principal investigator
Hasan Kalyoncu University