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临床试验/NCT06461845
NCT06461845已完成不适用

Effect of Whole Body Vibration Effect on Trunk Control, Functional Performance and Selective Control of Lower Extremity in Children With Cerebral Palsy

Riphah International University2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2024年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
PEDI SCALE for functional performance

研究概览

简要总结

Permanent neurological disorders such as cerebral palsy lead to problems with motor, sensory, and cognitive functions, which in turn limit one's ability to do certain activities. While the exact causes of cerebral palsy differ from child to child, anoxia-induced brain injury is a major cause of the disorder. The body parts affected, tone, and involuntary motions are used to categorise cerebral palsy. Among all the forms, spastic CP is the most prevalent. In individuals with CP, postural stabilisation and adaptations of the head, trunk, pelvic, and shoulder girdles grow more slowly. The primary problem with CP children is their gross movement pattern, which prevents them from performing single joint movements. Muscle strength increases significantly with WBV exercise training, which also reduces spasticity and enhances CP children's motor function. This study is important because it will determine whether WBV improves trunk control, functional performance, and lower limb selective control.

Data from Rising Sun Institute will be gathered for this randomised clinical trial. 38 patients will be included in the study. The study's inclusion criteria will include CP children with ages between 6 and 12 years old, those who can stand or walk alone (even with unusual gait patterns), GMFCS I and II, and children with diplegic cerebral palsy. Children with cerebral palsy (CP) who have had a lower limb fracture, fixed contracture, or other deformity, as well as those who have had a botulinum toxin injection or selective dorsal rhizotomy within the last six months, will not be eligible. Stretching exercises, strengthening exercises, trunk control facilitation, and rightening reaction facilitation will be the specific physical therapy treatments administered to group A. In addition, group B will receive WBV in addition to the specific physical therapy treatments (stretching exercises, strengthening exercises, trunk control facilitation, and rightening reaction facilitation). For two months, the 30-minute sessions will be held three times a week. The Modified Trost Test will test selective lower limb control, the PEDI scale will assess functional performance, and the Trunk Control Measurement Scale will monitor trunk stability before and after sessions. SPSS version 26 will be utilised for data analysis.

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 (Participant)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • • Childrens who follow verbal command
  • Childrens who can stand or walk alone (either with altered pattern)
  • Age limit: 6 -12 years
  • GMFCS I & II
  • Diplegic Cerebral palsy

排除标准

  • • Childrens with history of fracture in last 6 months
  • Childrens with fixed contracture or other deformity of lower limb
  • Childrens having visual or auditory impairments
  • Selective dorsal rhizotomy or botulinum toxin injection to lower extremities within past six months

结局指标

主要结局

PEDI SCALE for functional performance

时间窗: Baseline to 8 weeks

This scale is use for assessment of functional performance. It is composed of 197 items, subdivided into three domains(22). Mobility (59 items, involving tub transfers, toilet transfers, indoor and outdoor locomotion, and climbing stairs); Self-care (73 items involving eating, dressing, grooming); Social function (65 items related to communication with comprehension and expression, problem-solving, interactions with peers and adults and safety awareness). Each item scores (0) for "unable" to perform the activities or (1) for "capable

.Trunk Control Measurement Scale (TCMS) for trunk control

时间窗: Baseline to 8 weeks

To access trunk control in CP child we choose TCMS, it assesses seated trunk control in three dimensions static sitting balance, dynamic sitting balance and dynamic reaching. The maximum score is 58 points. The items are scored from 0 to 3, with 0 being the inability to perform the task and 3 being the complete performance of the item (20).

Modified Trost Test for selective control of lower extremity

时间窗: Baseline to 8 weeks

This test is used for assessment of selective motor control of lower extremity. It is a 3-point scale with assessment of ankle dorsiflexion, knee extension, hip flexion and hip abduction. * 0 point for Only patterned movement observed (total synergy) * 1 for Partially isolated movement observed (partial synergy) * 2 for Completely isolated movement observed (no synergy)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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