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临床试验/NCT07249866
NCT07249866尚未招募不适用

Effect of Robotic Assisted Therapy on Hand Functions, Grip Strength and Proprioception in Children With Hemiplegia

Cairo University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
32
试验地点
1
主要终点
hand grip strength by hand held dynamometer

研究概览

简要总结

Statement of the problem:

Does robotic assisted therapy have an effect on hand functions, grip strength and proprioception in children with hemiplegic cerebral palsy?

Significance of the study:

New technologies allow and promote active involvement, leading directly to functional changes that are far beyond those obtained with conventional therapy. Many features of robotic therapy may contribute to enhanced recovery of upper limb motor function. These include task-specific practice, intensity of repetition, robotic assistance, enhanced sensory feedback, continual motivation (because every trial yields a degree of success, even if robot assistance is required).

The implementation of robotics with hemiplegic cerebral palsy focuses on functional motor performance by providing intensive repetitive training, sensorimotor integration and cognitive engagement through goal-directed tasks to address the underlying symptoms. Robotic technologies offer numerous potential advantages over conventional therapies, chief among these being the ability to provide high-intensity repetitive training. Robotic treatment is a novel approach that has demonstrated promise in enhancing motor function, enhancing the quality of life, and lessening the burden on caregivers.

详细描述

Thirty two children with hemiplegic cerebral palsy from both sexes according to G*power analysis (α= 0.05 , Power= 0.90 , effect size = 0.89) Their ages range from 6- 9 years. Mild to moderate degree of spasticity, according to modified Ashworth scale (grade 1 to 2).

Motor function level will be I and II according to gross motor function classification system.

Assessment will be conducted using Bruininks Oseretsky test of motor proficiency scale 2nd edition (BOT-2) for assessment of fine motor control , handheld dynamometer will be used for measuring hand grip strength and digital goniometer for measuring wrist joint sense of position.

Children in the study group will receive robotic assisted therapy.

Null 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 (Participant)

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Their ages range from 6-9 years
  • •They have mild to moderate spasticity (grade 1- 2) according to Modified Ashworth Scale
  • •Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS
  • •Their manual abilities will be at level II and Level III according to Manual Ability classification system
  • •They will be able to understand and follow instructions

排除标准

  • •Fixed deformity in any joints of the upper limb.
  • •Previous history of surgical intervention in the upper limb.
  • •Auditory, visual and cognitive problems.
  • •Botulinum Toxin injection in last 6 months.

研究组 & 干预措施

Robotic assisted therapy

Experimental

robotic hand assisted therapy using robotic gloves for 8 weeks 3seesions / week each session lasts 30 minutes including passive , active assisted, active resisted, mirroring and gaming mode

干预措施: Hand rehabilitation robotic gloves (Device)

Robotic assisted therapy

Experimental

robotic hand assisted therapy using robotic gloves for 8 weeks 3seesions / week each session lasts 30 minutes including passive , active assisted, active resisted, mirroring and gaming mode

干预措施: occupational therapy (Other)

Traditional occupational therapy

Active Comparator

3 sessions/ week for 8 weeks and each session lasts 30 minutes using scissors - Knocking peg board with hammer- Building towers with rings-- Cubes insertion into wide muzzle jars- Playing with clays and form small balls and rolls

干预措施: occupational therapy (Other)

结局指标

主要结局

hand grip strength by hand held dynamometer

时间窗: 8 weeks

the hand grip strength will be measured by hand held dynamometer

hand functions ( fine motor precision and integration measured by Bruininks-Oseretsky Test of Motor Proficiency

时间窗: 8 weeks

hand functions will be measured by Bruininks-Oseretsky Test of Motor Proficiency

wrist joint proprioception by digital goniometer

时间窗: 8 weeks

wrist joint position sense will be measured by digital goniometer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samah Attia El Shemy

professor and chairman of department of physical therapy for pediatrics

Cairo University

研究点 (1)

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