Effects of Vestibular Stimulation in Addition to Conventional Physiotherapy in Improving Gross Motor Function and Mobility in Children With Spastic Diplegic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Gross Motor Function Measure (GMFM-88)
研究概览
简要总结
This was a RCT to determine and compare the effects of vestibular stimulation in addition to conventional physical therapy on gross motor function and mobility in children with spastic diplegic cerebral palsy.
详细描述
In this RCT , Experimental Group received Vestibular Stimulation along with Conventional therapy. Control Group received Conventional physiotherapy alone.
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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Participants with age limit of 6-12 years
- •Diagnosed cases of Spastic Diplegic Cerebral Palsy by Pediatric neurologist
- •Both genders (male/female)
- •Participants with GMFCS Level I-III
- •Participants with Grade I spasticity, Modified Ashworth Scale (MAS) • Participants able to understand and follow basic commands.
排除标准
- •• Children with history of vestibular disorders, epileptic fits or uncontrolled seizures from past six months
- •Children with any surgical procedure of the spine or lower limbs or Botox treatment in the last 6 months
- •Children with any visual or hearing impairment
- •Children having any fixed deformity, contracture or fracture limiting participation in therapy
- •Patients having VP shunt
结局指标
主要结局
Gross Motor Function Measure (GMFM-88)
时间窗: Assessment was performed at baseline and after 6 weeks of intervention.
Gross Motor Function Measure (GMFM-88) will be used to assess the progression of gross motor function over time in cerebral palsy affected children. The original GMFM version has 88-items and divided into five dimensions. each item scored on a 4-point ordinal scale of 0 to 3, where: * 0 shows that the participant does not begin the activity * 1 show that the participant initiates the activity (completes \< 10% of the activity) * 2 show that the participant completes the activity partially (performed from 10 to 99% of the activity) * 3 show that the participant finishes the activity (100%) * NT show that the participant was not tested For each item, maximum of three trials is permitted and the best one will be recorded. Scores for each group are expressed as a percentage of the its highest score and the total score is calculated by summing the percentage scores for each of the five groups/dimensions.
10-Meter Walk Test (10MWT)
时间窗: Assessment was performed at baseline and after 6 weeks of intervention
The 10 Meter Walk Test was used to determine functional mobility in children with spastic diplegic cerebral palsy. The test will be conducted on a 14 m pathway, including the starting and ending points, with a 2 m walk-in section. The time taken to reach the midpoint of the 10 m walk will be recorded.
Timed Up and Go (TUG) test
时间窗: Assessment was performed at baseline and after 6 weeks of intervention.
Mobility of children was evaluated via timed get up and go (TUG) test and its results were recorded.(15) In this test, the duration of standing up from an armchair, walking up to 3 m, turn walk back, and sitting on the chair was measured. (16) Interpretations are as follow: * \<10 seconds = normal * \< 20 seconds = good mobility, can go out alone, mobile without a gait aid. * \< 30 seconds = problems, cannot go outside alone, requires a gait aid.
次要结局
未报告次要终点