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临床试验/NCT06398119
NCT06398119已完成不适用

Effect of Visuomotor Training Using Pablo System on Hand Function in Children With Hemiplegic Cerebral Palsy: A Randomized Controlled Trial

Umm Al-Qura University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change from baseline spasticity degrees at 3 months

研究概览

简要总结

The aim of this study was to investigate the efficacy of Virtual reality on hand function in Saudi children with hemiplegic cerebral palsy.

详细描述

The aim of this study was to evaluate the effect of Virtual reality on hand function in children with hemiplegic CP. Forty children with hemiplegic CP were assigned randomly into two groups (A & B). Control group (A) was received conventional rehabilitation program for the hand. Study group (B) was received conventional rehabilitation program as in group (A) in addition to virtual reality by using the Pablo system.Patients' evaluation was carried out before and after training to assess hand function.

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研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • They had a diagnosis of spastic hemiplegia derived from medical records.
  • Scored I-III on the Manual Ability Classification System.
  • Not have musculoskeletal disorders that would make it difficult for them to use the VR.
  • They had normal or corrected hearing and vision.
  • They had no prior experience with the VR.
  • They comprehend and follow straightforward instructions to complete the tasks.

排除标准

  • They have had upper limb surgery within the last six months.
  • They have uncontrollably occurred seizures.
  • They have medical conditions that can make using virtual reality dangerous.
  • They have attention deficit issues.

结局指标

主要结局

Change from baseline spasticity degrees at 3 months

时间窗: Baseline and 3 months post-intervention

Using the Modified Ashworth Scale, the degree of upper limb spasticity was assessed. Based on the degree of muscle resistance felt by the therapist in response to a passive stretch of a joint, this sixfold scale goes from 0 (no spasticity) to 4 (fixed muscle contracture). In this study, the wrist flexor, elbow flexor, and shoulder adductor were examined. In order for the therapist to provide a score, the passive movement was done three times.

Change from baseline grip and pinch strength at 3 months

时间窗: Baseline and 3 months post-intervention

Using dynamometry, the strength of the pinch grasp and power were measured and reported in kilograms. A hydraulic hand dynamometer was used to test the power grip strength.The average of the three trials that each participant completed was used for analysis. Every child was instructed to sit on a chair that could be raised or lowered, with a backrest for support, and to keep their head in the middle. They also instructed to flex their hips and knees to a 90-degree angle and keep their feet flat on the ground. With the forearm halfway between supination and pronation, the elbow joint flexed 90 degrees, and the wrist joint in a neutral posture, the arm was positioned next to the torso. Next, the participant was instructed to grasp the dynamometer handle and squeeze it as hard as possible before letting go of it.

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

Shamekh Mohamed El-Shamy

Professor

University of Hail

研究点 (2)

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