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临床试验/NCT06729190
NCT06729190招募中不适用

Combined Effect of Biofeedback and Functional Electrical Stimulation on Upper Limb Functions in Children With Hemiplegia

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12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
招募中
入组人数
40
试验地点
1
主要终点
hand function in children with CP

研究概览

简要总结

40 children with hemiplegia cerebral palsy from both sex will be recruited from outpatient clinic of abo resh hospital ,their age ranged from 5-10 years

详细描述

40 children with hemiplegia cerebral palsy from both sex will be recruited ,their age ranged from 5-10 years, treatment includes functional electrical nerve stimulation and biofeedback to assess their combined effect on upper limb function

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
None

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Their age will range from 5 to 10 years.
  • •Spasticity grade range from 1+ to 2, according to Modified Ashworth Scale (MAS) (Bohannon and Smith, 2011).
  • •Their UL ability function will be at level II according to Manual Ability Classification System (MACS) (Penta et al., 2001).
  • •They will be able to follow instructions.

排除标准

  • •Loss of sensation
  • •The presence of visual or auditory impairments.
  • •Musculoskeletal problems or fixed deformities in the upper extremities.
  • •Seizures.
  • •Surgical interference in upper limbs.
  • •Botulinum toxin injections in the last 6 months.

研究组 & 干预措施

Group A

Placebo Comparator

Physical therapy program The exercise session for one hour for each child , conducted 3times/ week for 3 successive months.

  1. Flexibility exercises for shorted muscles and spastic muscles.
  2. Strengthening training focusing on the trunk lower limb and upper limb muscles for weak muscles.
  3. Postural control exercise in different positions and different surfaces
  4. General endurance training
  5. Exercises to facilitate hand function
  6. Exercises included, grasping a cube, transferring cube, removing and placing pegs, releasing cube and placing cubes. Strengthening exercises of the intrinsic muscles of the hand

干预措施: Physical therapy program (Procedure)

Group B

Experimental

The exercise session for one hour for each child same as group A, conducted 3times/ week for 3 successive months plus the combined biofeedback therapy and FES at anti spastic muscles (shoulders flexors, elbow and wrist extensors

干预措施: Physical therapy program (Procedure)

Group B

Experimental

The exercise session for one hour for each child same as group A, conducted 3times/ week for 3 successive months plus the combined biofeedback therapy and FES at anti spastic muscles (shoulders flexors, elbow and wrist extensors

干预措施: biofeedback (Device)

结局指标

主要结局

hand function in children with CP

时间窗: pre intervention and re assessed after 3 months of treatment

hand function in children with CP will be assessed by The Quality of Upper Extremity Skills Test

次要结局

  • Range of motion(pre intervention and re assessed after 3 months of treatment)
  • muscle grip strength(pre intervention and re assessed after 3 months of treatment)

研究者

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

Alaa Eldin Taha Ramadan

Assisstant lecturer

Cairo University

研究点 (1)

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