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临床试验/NCT03742999
NCT03742999Unknown不适用

Effectiveness of Visual and Auditory Feedback on Eye-hand Coordination in Children With Hemiplegic Cerebral Palsy

Princess Nourah Bint Abdulrahman University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
45
试验地点
2
主要终点
Change from Baseline Peabody Developmental Motor Scale at 3 months (2nd edition) (PDMS-2)

研究概览

简要总结

The aim of this study was to investigate potential benefits of adding augmented biofeedback training to standard therapy in improving eye-hand coordination in children with hemiplegic cerebral palsy .Participants were divided randomly into three equal groups. Group (A) received specially designed program of physical therapy intervention strategies to facilitate visual motor integration and visual perception over a period of three months. Group (B) received augmented biofeedback training only, and group (C) received augmented biofeedback training and same physical therapy program as group (A).

详细描述

Children were assigned randomly into three groups of equal number (A, B and C). Children were selected randomly by collecting all names of children that matched the inclusion criteria of the study then upload the names and gender using an electronic program (SPSS) which divided the sample into three equal groups (A), (B) & (C). Group A: this group included fifteen children with spastic hemiplegic CP. Children of this group received specially designed program of physical therapy exercises to facilitate eye-hand coordination to improve visual-motor coordination and grasping skills, which included: unbutton buttons, and button in all again; put the pellets in the bottle as fast as he/she can; place the shapes on its form board; build steps, wall, pyramid and a tower from cubes; cut out a line, square, triangle, and rectangular shapes on a paper by scissor; string squared cubes and lace the holes of strip. The tools used in training program were: button strip, lacing strip and its lace, mottle with screw- on cap, markers with different colors, beads and its lacing, square cubes, pellets, papers, blunt scissors, colored cubes, different types of form board and its shapes. Adjusted chair and table were used to accommodate differences in children's body built. Children were trained for 60 minutes per session, three times a week for three consecutive months.

Group B: this group included fifteen children with spastic hemiplegic CP. Children of this group received training using the E-Link Upper Limb Exerciser for 60 minutes per session, three times a week for three consecutive months. Group C: this group included fifteen children with spastic hemiplegic CP. Children of this group received the same physical therapy program as conducted for group A, and training with E-Link Upper Limb Exerciser as conducted for group B. The training was for 60 minutes per session, three times a week for three consecutive months.

The participated children were assessed by the Peabody Developmental Motor Scale (2nd edition) (PDMS-2) Test before and after the three months of the treatment program. The average time required for evaluating each child was 40 min. The assessment and training methods were applied according to the instructions provided in the test and equipment manuals, no modifications were necessary.

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 (Outcomes Assessor)

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

  • Grade of spasticity between 1 to 1+ according to Modified ashworth Scale,
  • The ability to handle objects independently was between level (I) and (II)
  • According to Manual Ability Classification System (MACS)
  • No history of epilepsy
  • No botulinum toxin A treatment for the upper extremities in the previous 6 months
  • Able to understand and follow verbal commands and instructions

排除标准

  • Presence of visual or auditory impairments
  • Significant tightness or fixed deformities in the upper limbs
  • Severe spasticity
  • Severe cognitive impairment

研究组 & 干预措施

group A

Active Comparator

Group (A) physical therapy program for 60 minutes per session, three times a week for three consecutive months

干预措施: physical therapy program (Procedure)

group B

Active Comparator

Group (B) E-Link Upper Limb Exerciser (augmented biofeedback training)for 60 minutes per session, three times a week for three consecutive months

干预措施: E-Link Upper Limb Exerciser (Device)

group C

Experimental

group (C) physical therapy program and E-Link Upper Limb Exerciser

干预措施: physical therapy program and ELink Upper Limb Exerciser (Combination Product)

结局指标

主要结局

Change from Baseline Peabody Developmental Motor Scale at 3 months (2nd edition) (PDMS-2)

时间窗: 10-15 minutes total, it is taken at base line and after 3 months of treatment

Peabody Developmental Motor Scale provides assessment and training or remediation of gross and fine motor skills for children. It composed of two scores (Gross Motor and Fine Motor) divided into six subtests (Reflexes, Stationary, Locomotion, Object Manipulation, Grasping, Visual-Motor Integration). scale ranges from 2, 1, or 0 ( 2 is the better outcome, 0 is the worse outcome)

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

Reem M Alwhaibi

associate professor

Princess Nourah Bint Abdulrahman University

研究点 (2)

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