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临床试验/NCT07248566
NCT07248566招募中不适用

Effects of Cognitive Sensory Motor Training Therapy on Dexterity and Upper Limb Function in Children With Cerebral Palsy

Riphah International University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
2
主要终点
Action Research Arm Test:

研究概览

简要总结

The current study will be randomized controlled trial, data will be collected from Central Park Teaching Hospital. The study will include 32 participants equally divided into two groups and randomly allocated. Inclusion criteria for this study will be consist of diagnosis with cerebral palsy, age 6-12, ability to participate in cognitive sensory motor training therapy, stable medical condition, and informed consent from parents/guardians. Participants with severe cognitive impairments, unstable medical condition, history of spinal cord injury or deformity, diagnosis with other neurological conditions, and visual or hearing impairments will be excluded from the study.. The Experimental group will receive Cognitive Sensory Motor Training Therapy and Routine Physical Therapy, while the Control group will receive Routine Physical Therapy.Cognitive Sensory Motor Training Therapy (CSMT) for 35 minutes, five times a week, over 12 weeks. Data collection will be done before and after the interventions.Outcome measures will include the dexterity, and upper limb function.Tools used for data collection will be Action Research Arm Test and Box and Block Test. Data analysis will utilize SPSS version 25.00.

详细描述

Cerebral palsy defined as a neuro-impairment with motor disability caused by a non- progressive defect or lesion of the immature brain. Cerebral palsy (CP) impact approximately

1 in 500 children worldwide, affecting motor function, muscle tone, and coordination.

Children with CP will experience limitations in daily activities, social participation, and quality of life due to impaired upper limb function. To address this, rehabilitation strategies will focus on enhancing dexterity, and upper limb function. The aims of the study is to examine the effects of cognitive sensory motor training therapy on dexterity and upper limb function in children with CP. The current study will be randomized controlled trial, data will be collected from Central Park Teaching Hospital. The study will include 32 participants equally divided into two groups and randomly allocated. Inclusion criteria for this study will be consist of diagnosis with cerebral palsy, age 6-12, ability to participate in cognitive sensory motor training therapy, stable medical condition, and informed consent from parents/guardians. Participants with severe cognitive impairments, unstable medical condition, history of spinal cord injury or deformity, diagnosis with other neurological conditions, and visual or hearing impairments will be excluded from the study.. The Experimental group will receive Cognitive Sensory Motor Training Therapy and Routine Physical Therapy, while the Control group will receive Routine Physical Therapy.Cognitive Sensory Motor Training Therapy (CSMT) for 35 minutes, five times a week, over 12 weeks. Data collection will be done before and after the interventions.Outcome measures will include the dexterity, and upper limb function.Tools used for data collection will be Action Research Arm Test and Box and Block Test. Data analysis will utilize SPSS version 25.00.

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
Single (Participant)

盲法说明

Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Children aged 6-12 years with cerebral palsy
  • Diagnosis confirmed by pediatric neurologist or rehabilitation specialist
  • Ability to follow simple instructions and participate in therapy sessions.
  • Participants had to be able to focus attention on demonstrate level II and III on the Gross
  • Motor Function Classification Scale (GMFCS)
  • Level II or III on the Manual Ability Classification System (MACS)

排除标准

  • Visual impairment or hearing defect
  • Severe cognitive decline and aphasia
  • Contractures that could limit the patient from maintaining the extended arm in a comfortable position,

结局指标

主要结局

Action Research Arm Test:

时间窗: The test can be completed in an average of 10 minutes but requires specific materials

The ARAT is a standardized measure of the upper extremity (arm and hand) function based on four movements : grasping, grip-ping, pinching and gross movements of shoulder,elbow and fingers. ARAT has an ordinal 4-point scale (0-3) for 19 items. Scoring is determined as follows: 0, patient cannot perform any part of task;1, patient is able to lift the object completely from the platform; 2, function is performed fully but clumsily or with great difficulty; and 3, the movement is performed normally. The maximum score for each arm is 57 points.

Box and Block Test:

时间窗: The number moved in 60 seconds is the recorded score.

The box and block test 13 will be used to evaluate gross manual dexterity. The setup consists of two adjacent boxes of the same size (53.7 × 25.4 × 8.5cm), one of them filled with 150 blocks (2.5 cm 3).Between the two boxes, there is a partition 15.2 cm in height. The patient must move blocks one by one from one box to the other, over the partition.

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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