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临床试验/NCT07367477
NCT07367477Enrolling By Invitation不适用

HORIZONTAL VERSUS VERTICAL UPPER EXTREMITY PERFORMANCE ON HAND SKILLS AND TRUNK CONTROL IN BILATERAL CEREBRAL PALSY

Raghda Gamal Ateya Abd-Elbary1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Change in Fine motor proficiency

研究概览

简要总结

The goal of this quasi-experimental study is to investigate and compare the effects of horizontal and vertical upper extremity performance on hand skills and trunk control in children with bilateral spastic cerebral palsy; could include any of the following: both gender, age ranged from 5 years to 8 years. The main question it aims to answer [is/are]:

There will be no significant difference effect between horizontal and vertical upper extremity performance on hand skills and trunk control in children with bilateral spastic cerebral palsy.

详细描述

This study aims to investigate the effects of to investigate and compare the effects of horizontal and vertical upper extremity performance on hand skills and trunk control in children with bilateral spastic cerebral palsy. The research will evaluate fine motor proficiency, upper extremity function and trunk stability from sitting through a controlled and structured intervention program.

Participants will undergo designed Occupational Therapy program will be applied for 90 minutes, three days per week for successive three months for the both groups by the researcher The study adopts a quasi-experimental design, with thirty participants allocated into two groups of an equal number, twenty children for each group. Two group will be identified as group (A) and group (B).

Data will be analyzed using paired t-test will be used for within group comparison before and after the intervention, for each variable and independent t-test was used to compare the demographic data and the baseline characteristics of both groups for all measured variables, pre and post treatments, with a significance level set at p < 0.05.

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 (Participant)

入排标准

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

入选标准

  • Children with BSCP, their chronological age will be ranged from 5 years to 8 years.
  • Their level of motor function will be I or II according to Gross Motor Function Classification System - Expanded and Revised.
  • The degree of spasticity for these children will ranged from grade 1 to 1⁺ according to Modified Ashworth Scale.
  • Their level of fine motor function will be I or II according to The Bimanual Fine Motor Function.
  • All children's level of segmental trunk control will be level 7 (full trunk control) according to Segmental Assessment of Trunk Control.
  • They will be able to follow instructions during evaluation and treatment.

排除标准

  • Surgical interference in upper limbs and/or spine that may restrain the child performance during activities.
  • Orthopedic problems or fixed deformities in the vertebral column and/or upper extremities.
  • Uncontrolled seizures.
  • Visual or hearing impairment.
  • Receiving special medication affecting muscle and /or mental function.

研究组 & 干预措施

Group (A)

Active Comparator

Children in this group will receive a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface.

干预措施: a designed occupational therapy (OT) program to improvement hand skills conducted on a horizontal surface. (Procedure)

Group (B)

Experimental

Children in this group will receive the same designed OT program given to group (A) conducted on a vertical surface.

干预措施: a designed occupational therapy program to improvement hand skills conducted on a vertical surface. (Procedure)

结局指标

主要结局

Change in Fine motor proficiency

时间窗: Before and after the three months of treatment

Evaluated using the fine motor form of the Bruinink-Oseretsky test for motor proficiency 2nd edition (BOT-2)

Change in upper extremity function

时间窗: Before and after the three months of treatment

Evaluated using the Quality of Upper Extremity Skills Test (QUEST)

Change in trunk stability from sitting

时间窗: Before and after the three months of treatment

Evaluated using the Trunk Control Measurement Scale (TCMS) to assess static and anticipatory trunk control

次要结局

未报告次要终点

研究者

发起方
Raghda Gamal Ateya Abd-Elbary
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Raghda Gamal Ateya Abd-Elbary

Physical Therapy Specialist

Cairo University

研究点 (1)

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