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临床试验/NCT06198153
NCT06198153已完成不适用

Comparative Effects of Stationary Cycling and Progressive Functional Training on Balance and Motor 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 22 人开始时间: 2023年11月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
GMFM Scale

研究概览

简要总结

Cerebral palsy is not a progressive disease but movement problem and musculoskeletal disorders in cerebral palsy change with time. Children with CP usually with the lower limb involvement presents with muscle weakness, limited muscular control which results in muscular insufficiency, coordination and balance impairment. These impairments effect the normal activities of child in daily living. There are many children who have good cognition but poor lower limb coordination which is leading cause of disability in them and multiple factors are responsible for them like lake of awareness in parents, no time, expensive therapy program and inappropriate techniques.

详细描述

The study will be randomized clinical trial and will be conducted in Bahawalpur. The study will be completed in time duration of 6 months after approval of synopsis. Non probability convenience sampling technique will be used and 22 children will be recruited in the study meeting the inclusion criteria. The participants will be divided into two groups through randomization using lottery method. Group A will perform 10-15 minutes of stationary cycle training, 3 times a week for 6 weeks. While group B will be given progressive functional training 3 times a week for 10-15 minutes for 6 weeks. Pediatrics balance scale will be used to measure functional balance skills and GMFS scale will be used to measure gross motor function. The data will be assessed at the baseline and after 6 weeks of intervention. After data collection data will be analyzed by using SPSS version 25.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • • Children with cerebral palsy (Hemiplegic)
  • Age: 4 to 10 years
  • Able to sit without foot or arm support
  • Children with level I & II on Gross motor function classification system
  • Normal cognitive function; can understand and follow command

排除标准

  • • Children with mental retardation.
  • Visual and auditory disorders.
  • History of any surgical procedure.
  • Any infections, unstable seizures, etc.
  • Fixed deformities or contractures of lower limbs.

研究组 & 干预措施

Stationary Cycling

Active Comparator

This group will receive stationary cycling for 6 weeks.

干预措施: Stationary Cycling (Other)

Progressive Functional Training

Experimental

This group will receive Progressive Functional Training programs for 6 weeks.

干预措施: Progressive Functional Training (Other)

结局指标

主要结局

GMFM Scale

时间窗: 6weeks

The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. (13) However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. Scoring Key: 0= does not initiate 1. initiates 2. partially completes 3. completes 9 (or leave blank) = not tested (NT) \[used for the GMAE-2 scoring\*\] It is important to differentiate a true score of -0‖ (child does not initiate) from an item which is Not Tested (NT) if you are interested in using the GMFM-66 Ability Estimator (GMAE) Software. It is reliable with 95% confidence interval=0.965-0.994. The validity with 95% confidence interval=0.972-0.997

Pediatrics Balance Scale

时间窗: 6 weeks

The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. (15) The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points Reliability testing performed with a sample of 20 children ages 5-15 years old with mild to moderate motor impairments showed good test-retest reliability (ICC=0.998) and good interrater reliability (ICC=0.997).

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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