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临床试验/CTRI/2025/08/092589
CTRI/2025/08/092589尚未招募3 期

Effectiveness of Combined Intensive Interventional Approach In Improving Motor Functions In Children With Cerebral Palsy: A Prospective 3 Arm Parallel Single Blinded Randomized Controlled Trial

Self Ranavari Bhagya Sri Bai1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2025年8月19日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
39
试验地点
1
主要终点
1. Quality of Upper Extremity Skills Test (QUEST),

研究概览

简要总结

Children with early brain injuries are frequently referred to physiotherapy only after developmental delays become evident. Even the therapy provided is often infrequent and lacks intensity. The most common of these developmental delays include cerebral palsy (CP), defined as a non progressive disorder which is a result of injury to a developing brain.

The dosage of interventions that includes duration, intensity and frequency are considered to be one of the important aspects of physiotherapy interventions as it is directly effects the outcomes of the child.

Only a few studies have proven the effectiveness of combination of different interventions aiming at multiple aspects of the body at the same time such as intervening both Upper extremity (UE) and Trunk or Trunk and Lower extremity (LE) or all the aspects like UE, LE and Trunk, where the most important period of timeline of development will be lost, and the caregivers concerns and expectations should also be taken into consideration.

There is a need to know the effectiveness of combination of most of the proven targeted exercises, providing equal importance and interventions for all aspects of the body as a unit rather working on anyone aspect. The current study aims to check the effectiveness of combination of intensive targeted physiotherapy interventions on the motor functions in children with cerebral palsy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Children of age 4-10 years of either gender
  • Children with cerebral palsy confirmed by medical practitioner or paediatric neurologist
  • Children with GMFCS levels II-III with minimum 25-30 percentage of impairment in the outcomes like GMFM 66, QUEST, PDFM raw scores
  • Children with score of greater than 24 on Mini-Mental State Examination for Children (MMC) to understand and follow the commands of therapist.
  • Children and parents who gave consent to participate in the study.

排除标准

  • Children with genetic disorders (Downs syndrome) and other diagnoses than CP
  • Children with severe complications like uncontrolled seizures
  • Children who underwent botulinum toxin, surgeries in the last 6 months.

结局指标

主要结局

1. Quality of Upper Extremity Skills Test (QUEST),

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

2. Fine motor dimension of Peabody Developmental Motor Scale (PDMS-2)(PDFM),

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

3. ABILHAND,

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

4. Computer games-assisted Upper Extremity (CUE) assessment tool,

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

5. Trunk Control Measurement Scale (TCMS),

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

6. Temporal variables of gait step length, stride length and velocity,

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

7. Selective Control

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

Assessment Of Lower Extremity (SCALE),

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

8. Physiological Cost Index,

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

9. Gross Motor Function

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

Measure-66 (GMFM-66),

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

10. Child engagement in daily life measure version 2,

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

11. Pediatric Quality of Life Inventory 4.0 Cerebral Palsy Module (PedsQL 4.0 Cerebral

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

Palsy Module).

时间窗: At baseline, 4th week and 8th week (0,4 & 8)

次要结局

未报告次要终点

研究者

发起方
Self Ranavari Bhagya Sri Bai
申办方类型
Other [Self funding]
责任方
Principal Investigator
主要研究者

Ranavari Bhagya Sri Bai

SDM College of Physiotherapy

研究点 (1)

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