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临床试验/CTRI/2024/07/071625
CTRI/2024/07/071625已完成不适用

A comparative analysis of effectiveness of mcimt over bimanual therapy on the upper limb functions in children with hemiplegic cerebral palsy

Shamama Athar1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
MACS(MANUAL ABILITY CLASSIFICATION SYSTEM)

研究概览

简要总结

Introduction: Cerebral palsy (CP) is a neurological disorder that affects movement, muscle tone, and posture. It is caused by damage to the developing brain, usually before or during birth. This damage disrupts the brain’s ability to control movement and posture, leading to difficulties in coordination, balance, and motor skills. The severity of cerebral palsy can vary widely from person to person. While some individuals may have only minor difficulties with movement, others may be severely affected and require extensive assistance with daily activities.. Motor function disorders, which are the core symptoms of cerebral palsy, are frequently accompanied by other dysfunctions, such as: sensation, perceptual, cognitive, communication and behavioural disorders, epilepsy, and secondary musculoskeletal disorders. In a recent systematic review from 2019, the overall pooled prevalence of cerebral palsy per 1000 children surveyed is 2.95, (95%CI 2.03–3.88). The pooled prevalence conducted in rural settings is 1.83 (95% CI 0.41–3.25). As children grow, they may experience delays in reaching developmental milestones such as crawling, walking, and speaking.·Exhibition of abnormal movements

·Involuntary muscle contraction,

·Jerky movements, or athetosis,

·Poor coordination,

·Balance problems,

·Difficulty with fine motor skills such as writing, buttoning clothes

·Seizures

·Intellectual disability

·Vision

Hearing impairments

·         mCIMT (Modified Constraint Induced Movement Therapy) : It has emerged as a main treatment approach for children with CP. As clinical use of mCIMT in children continues to grow, additional studies are needed to determine how basic parameters of the therapy affect outcomes. The application of modified (less frequent and more prolonged) constraint programmes (mCIMT) for young children seems more child friendly.

  • Bimanual Therapy: Bimanual therapy is a specialized rehabilitation approach designed to improve the functional abilities of individuals, particularly children, with cerebral palsy. Bimanual therapy focuses on enhancing the coordination and integration of both hands simultaneously to promote independence and participation in various tasks. Bimanual therapy typically involves a combination of therapeutic activities and exercises tailored to the individual needs and abilities of the child.

**NEED OF STUDY:**Cerebral palsy (CP) is a neurological, non-progressive disorder that affects the central nervous system. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, perception, cognition, communication, and behavior and by secondary musculoskeletal problem.

In this study, an effort will be made to find out the effectiveness of the Modified Constraint Induced Movement Therapy (mCIMT) and Bimanual Therapy in improving upper limb motor function in children with hemiplegic CP.

Though there is lack of evidence where both these therapies are compared. This is why an effort will be made to find out the effectiveness of mCIMT in comparison with Bimanual Therapy in improving the upper limb motor functions in children with hemiplegic CP.

OBJECTIVE OF RESEARCH:

1.      To evaluate the effectiveness of modified constraint induced movement therapy on improving the upper limb functions in children with hemiplegic cerebral palsy.

2.      To evaluate the effectiveness of bimanual therapy on improving the upper limb functions in children with hemiplegic cerebral palsy.

To find out and compare the effectiveness of mCIMT and Bimanual therapy on improving the upper limb functions in children with hemiplegic cerebral palsy.

RESEARCH HYPOTHESES

NULL HYPOTHESES (Hο):

There will be no significant difference between the effectiveness of modified constraint induced movement therapy and bimanual therapy in improving the upper limb functions in children with hemiplegic cerebral palsy.

ALTERNATIVE HYPOTHESES (H1):

There will be a significant difference between the effectiveness of modified constraint induced movement therapy and bimanual therapy in improving the upper limb functions in children with hemiplegic cerebral palsy.

Methodology: 30 children with hemiplegic cerebral palsy will be selected by convenient sampling. They will be divided into two groups, group A and group B. Each group will have 15 children. Group A will receive modified constraint induced movement therapy (mCIMT) and group B will receive bimanual therapy.A thorough assessment will be done regarding hand function with MACS (Manual Ability Classification System) and QUEST (Quality of Upper Extremity Skill Test) scale. After 10 weeks of treatment the children will be assessed again with the given scales to find out the parameters. Paired‘t’ test and independent‘t’ test will be done to find out which of the intervention is more effective.

Expected Outcome: It can be expected that, there will be some improvement in both group after the given interventions. It is to be found out if they are statistically significant or not, if yes, then which group is more significant? And whether there will be any prominent difference between the two interventions.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed as CP child with hemiplegia
  • Able to follow verbal instructions.

排除标准

  • Children with uncontrolled and recent epileptic seizures
  • Children with diplegia, quadriplegia
  • Children with Athetoid CP
  • Children with muscle contracture
  • Upper limb bone deformity Children with diagnosed ASD and ADHD
  • Have undergone any surgical procedure of upper limb
  • Unhealed fracture of upper limb.

结局指标

主要结局

MACS(MANUAL ABILITY CLASSIFICATION SYSTEM)

时间窗: The MACS scale will be measured on the 1st day of treatment and after completion of 10 weeks of treatment.

次要结局

  • QUEST(Quality of Upper Extremity Skill test)(1st day of treatment and after 10 weeks of treatment)

研究者

发起方
Shamama Athar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shamama Athar

Burdwan Institute of Medical and Life Sciences

研究点 (1)

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