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临床试验/NCT07244081
NCT07244081招募中不适用

Effects of Kinesiotherapy on Upper Limb Function and Activities of Daily Living in Children With Hemiplegic Cerebral Palsy

Riphah International University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年10月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
28
试验地点
1
主要终点
action arm research arm test

研究概览

简要总结

This study will be randomized controlled trial, data will be collected from BASES special education school sialkot , Allama Iqbal Memorial Hospital, sialkot and Lahore. The study will include 28 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be age of 8-13 years old of both sexes, ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ) and (GMFCS level Ⅰ-Ⅲ), ability to communicate needs and discomfort (verbally or non-verbally), No concurrent participation in other physical therapy and excluded with Severe visual and hearing impairments, severe cognitive disabilities, History of seizures, Recent (within 6 months) or planned orthopedic surgery, Concurrent use of botulinum toxin injections. Experimental group will perform both Kinesiotherapy protocol and conventional physical therapy while Control group will perform only conventional physical therapy for 8 weeks 2-3 times weekly with 45 min of each session. Outcomes to be analyzed will be upper limb function and Activities of daily living (ADLs). Tools used for data collection will be Action Research Arm (ARA) test, Pediatric Evaluation of Disability Inventory (PEDI). Data will be analyzed through SPSS version 26, 27.

详细描述

Cerebral palsy (CP) is a non progressive neurodevelopmental disorder affecting motor function, resulting from damage to the brain. Hemiplegic CP specifically impacting one side of the body with upper extremity generally more effected than the lower. Twenty percent of children with spastic CP have hemiplegia. Upper limb dysfunction and limited activities of daily living (ADLs) significantly impact quality of life, social participation, and independence. Kinesiotherapy, a movement-based therapy that incorporates movements to improve strength, function and mobility. shows promise effects on stroke patients, but its effectiveness on hemiplegic cerebral palsy requires rigorous investigation. This study aims to investigate the effectiveness of kinesiotherapy in improving upper limb function and ADLs in children with hemiplegic cerebral palsy.

This study will be randomized controlled trial, data will be collected from BASES special education school sialkot , Allama Iqbal Memorial Hospital, sialkot and Lahore. The study will include 28 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be age of 8-13 years old of both sexes, ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ) and (GMFCS level Ⅰ-Ⅲ), ability to communicate needs and discomfort (verbally or non-verbally), No concurrent participation in other physical therapy and excluded with Severe visual and hearing impairments, severe cognitive disabilities, History of seizures, Recent (within 6 months) or planned orthopedic surgery, Concurrent use of botulinum toxin injections. Experimental group will perform both Kinesiotherapy protocol and conventional physical therapy while Control group will perform only conventional physical therapy for 8 weeks 2-3 times weekly with 45 min of each session. Outcomes to be analyzed will be upper limb function and Activities of daily living (ADLs). Tools used for data collection will be Action Research Arm (ARA) test, Pediatric Evaluation of Disability Inventory (PEDI). Data will be analyzed through SPSS version 26, 27.

研究设计

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

入排标准

年龄范围
8 Years 至 13 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age: 8-13 years old both sexes
  • •Ability to follow simple instructions, able to sit or stand with support to participate in physical therapy sessions( MACS level Ⅰ-Ⅲ)(9) and (GMFCS level Ⅰ-Ⅲ)(10)
  • •Ability to communicate needs and discomfort (verbally or non-verbally)
  • •No concurrent participation in other physical therapy or rehabilitation programs

排除标准

  • •Severe visual and hearing impairments that would hinder participation
  • •Severe cognitive or intellectual disabilities that would impede understanding of instructions
  • •History of seizures or other neurological conditions that may impact participation
  • •Recent (within 6 months) or planned orthopedic surgery
  • •Concurrent use of botulinum toxin injections or oral medications affecting muscle tone(2).

研究组 & 干预措施

control group

Other

Following baseline assessments, participants will begin their respective 8-week intervention program with 2-3 times per week. The group A will receive base line conventional exercise program with standard physical therapy interventions as follow:

  • Stretching of tight muscles of affected upper limb.
  • Weight bearing of affected upper limb.
  • Manual dexterity exercises like grasp release, pack board activities.
  • Teaching of ADLs.
  • Functional task practice(2)

干预措施: control (Other)

experimental group

Experimental

Kinesiotherapy tailored exercises focusing on movement and exercise, The movements are as follows:Sitting on a chair, the participant had to lean forward to pick up an object previously placed on the floor.Sitting on a chair, the participant had to rotate the upper body, reaching out and grabbing an object on its side, at the height of his shoulders.Sitting on a chair, the participant had to clasp his hands and flex the shoulders.

Sitting on a chair in front of a table, the participant had to take objects numbered in ascending order and hand them over to the therapist.

Sitting on a chair holding a stick, the participant had to place one hand above the other, raising his hands as if holding on to the stick.Sitting on a chair in front of a table, the patient had to find similar playing cards. All cards were face down. Sitting on a stretcher, the participant had to laterally tilt his trunk, putting the weight on the upper limbs. The therapist maintained the elbow extension

干预措施: experimental (Other)

结局指标

主要结局

action arm research arm test

时间窗: baseline, 8 weeks

The Action Research Arm Test (ARAT) is a 19 item observational measures used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task maximum score 57 means better performance

pediatric evaluation of disability inventory

时间窗: baseline, 8 weeks

The PEDI is a standardized clinical assessment tool designed to measure the functional performance of children with typical development whose chronological age is below 7.5 years old, and the functional performance of children with disabilities whose functional capabilities are below those of a 7.5-year-old child. The PEDI can be used for children with developmental disabilities aged 6 months to 21 years and for individuals without disabilities aged less than 7 years(12) The PEDI is composed of 3 domains: functional skill, caregiver assistance, and modification. Each domain includes 3 sub-domains: self-care, mobility, and social function. The functional skill domain, which was used for measuring ADL performance, consists of 197 specific questions. Each child is assigned either 1 point for being capable of performing the assigned task or 0 points for incomplete performance or being unable to perform the task. The reliability of the functional skill subscale of the PEDI is very high.

action arm research arm test

时间窗: baseline, 8 weeks

The Action Research Arm Test (ARAT) is a 19 item observational measures used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. Items comprising the ARAT are categorized into four subscales (grasp, grip, pinch and gross movement) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task maximum score 57 means better performance

pediatric evaluation of disability inventory

时间窗: baseline, 8 weeks

The PEDI is a standardized clinical assessment tool designed to measure the functional performance of children with typical development whose chronological age is below 7.5 years old, and the functional performance of children with disabilities whose functional capabilities are below those of a 7.5-year-old child. The PEDI can be used for children with developmental disabilities aged 6 months to 21 years and for individuals without disabilities aged less than 7 years(12) The PEDI is composed of 3 domains: functional skill, caregiver assistance, and modification. Each domain includes 3 sub-domains: self-care, mobility, and social function. The functional skill domain, which was used for measuring ADL performance, consists of 197 specific questions. Each child is assigned either 1 point for being capable of performing the assigned task or 0 points for incomplete performance or being unable to perform the task. The reliability of the functional skill subscale of the PEDI is very high.

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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