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临床试验/NCT06966609
NCT06966609已完成不适用

Additional Effects of Cuevas Medek Exercises Along With Conventional Physical Therapy on Gross Motor Proficiency and Quality of Life, in Children With Spastic Diplegic Cerebral Palsy

Foundation University Islamabad1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年6月10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
56
试验地点
1
主要终点
Gross Motor Function

研究概览

简要总结

Cerebral palsy (CP) is a prevalent pediatric neurological disorder hindering movement and posture development due to non-progressive disruptions in brain development. Motor disorders along with dysfunctions in sensations, perception, cognition, communication, behavior and secondary musculoskeletal problems are also present in children with CP.

Cuevas Medek Exercises (CME) is an innovative, intensive and dynamic therapy approach for management of movement disorders. It evoke automatic postural responses in children with motor delay problems by application of distal support, triggering stronger gravity induced reactions to enhanced motor output by compelling both mind and body responses.

It incorporates antigravity posture, ROM, weight-bearing, and stretching into functional exercises; for improved agility, flexibility, balance and coordination.

详细描述

OBJECTIVES:

The objectives of this study are:

  1. To determine the additional effect of Cuevas Medek Exercises with conventional exercises on gross motor proficiency in children with spastic diplegic cerebral palsy.
  2. To determine the additional effect of Cuevas Medek Exercises with conventional exercises on quality of life of caregiver and children with spastic diplegic cerebral palsy.

HYPOTHESIS:

Alternate Hypothesis:

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

  • •diagnosed spastic diplegic cerebral palsy children
  • •age group 6-12 years old
  • •both male and female
  • •GMFCS II & III
  • •parents of spastic diplegic CP child

排除标准

  • •diagnosed cognitive impairment
  • •diagnosed hearing impairment and visual impairment
  • •children with planned surgical procedures during study period

研究组 & 干预措施

Interventional Group A

Experimental

It includes participants receiving cuevas medek exercise combined with conventional physical therapy for 12 weeks treatment.

  1. Stretching Exercises (PNF stretching)
  • 0-6 weeks; 3 sets (5 repetition of 20sec) 4 times a week
  • 6-12 weeks; 3 sets(10 repetition of 60sec) 4 times a week
  • Muscles included:

Flexors (hip, knee, ankle), extensors (hip, knee, ankle), abductor(hip) and adductors(hip) 2. Strengthening Exercises (Isometric muscle strengthening )

  • 3 sets ( 10 repetition)
  • Rest interval: 1min
  • Frequency: 3 times a week
  • Muscles included:

Flexors(hip, knee, ankle), extensors(hip, knee, ankle), abductor(hip) and adductors(hip) 3. Gait training Parallel bar walking 4. Cuevas Medek Exercise(99 exercises)

  • Frequency: 3 times a week
  • Duration: 45mins
  • Repetition: 3-8 times
  • Exercises divided into following, will be administered according to patient need/goal;
  1. Head control
  2. Trunk control
  3. Trunk and hip control
  4. Coordination
  5. Balance reaction
  6. Stability

干预措施: Experimental Group (Procedure)

Interventional Group B

Active Comparator

It includes participants receiving conventional physical therapy for 12 weeks treatment.

  1. Stretching Exercises (PNF stretching)
  • 0-6 weeks; 3 sets (5 repetition of 20sec) 4 times a week
  • 6-12 weeks; 3 sets(10 repetition of 60sec) 4 times a week
  • Muscles included:

Flexors (hip, knee, ankle), extensors (hip, knee, ankle), abductor(hip) and adductors(hip) 2. Strengthening Exercises (Isometric muscle strengthening )

  • 3 sets ( 10 repetition)
  • Rest interval: 1min
  • Frequency: 3 times a week
  • Muscles included:

Flexors(hip, knee, ankle), extensors(hip, knee, ankle), abductor(hip) and adductors(hip) 3. Gait training Parallel bar walking Treatment time: 45mins

干预措施: Control Group (Procedure)

结局指标

主要结局

Gross Motor Function

时间窗: 12 weeks

Gross Motor Function Measure-88 score, will be used to assess gross motor function in children with cerebral palsy. It is a four point scale, consists of 88 items divided into five dimensions of gross motor function: a. lying and rolling, b. crawling and kneeling, c. sitting, d. standing, e. walking, running and jumping. It takes about 45 to 60 minutes. Equipments required for this measure tool are; mat, bench, toy and access to stairs. Item scores are summed to calculate raw and percent scores for each of the five dimensions. Then, Average the percent scores for each dimension to get the total score. Total score (in percent), will be compared on each assessment to find out the improvement in the individual through that specefic intervention.

Quality of Life

时间窗: 12 weeks

CP QOL Child Primary Caregiver It is a validated questionnaire that assesses the subjective well- being and happiness of children with CP. It consist of 66 questions and should be answered by caregivers of CP child, who report their perception of their child's quality of life of areas: well being and social acceptance, functionality, participation and physical health, emotional well being and self esteem, access to services, pain and disability impact and family health. The questionnaire is scored by summing the items to get a total score, with higher scores representing better quality of life.

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 (1)

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