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临床试验/NCT06332729
NCT06332729已完成不适用

Effect of Universal Exercise Unit Versus Functional Electrical Stimulation On Genu Recurvatum In Diplegic Cerebral Palsy Children

Mahmoud Reda Elsharkawy1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2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
已完成
发起方
入组人数
30
试验地点
1
主要终点
Range of motion using kinoviea software and digital goniometer

研究概览

简要总结

Summary:

Inclusion Criteria:

  • Children aged four to eight years.
  • Grade of spasticity ranging from 1 to 1+ on the Modified Ashworth scale.
  • Classified as Level I or II on the Gross Motor Functional Classification System (GMFCS).
  • Ability to follow verbal commands and instructions.

Exclusion Criteria:

  • Previous neurological or orthopedic surgery in the lower extremities.
  • Botox injection in the lower extremities within the past six months.
  • Fixed deformity in the joints of the lower limb.
  • Genu recarvatum secondary to surgery.
  • Severe hearing and visual defects.

Materials for Subject Selection and Evaluation:

  • Modified Ashworth Scale for muscle tone assessment.
  • Gross Motor Functional Classification System (GMFCS) for functional activity classification.
  • Digital goniometer for measuring the angle of knee hyperextension.
  • Lafayette Manual Muscle Tester for quantifying muscle strength.

Methods:

  • Assessment of muscle tone using the Modified Ashworth Scale, evaluating spasticity in calf muscles and hip/knee extensors.
  • Evaluation of gross motor function using the GMFCS.
  • Assessment of genu recarvatum using a digital goniometer.
  • Assessment of muscle strength using the Lafayette Manual Muscle Tester, focusing on hamstrings and tibialis anterior muscles.
  • Assessment of range of motion in the knee joint using Kinovea software.
  • Treatment procedures involving physical therapy sessions with a combination of exercises and interventions tailored to each group (Group A and Group B).

Group A Treatment:

- Designed physical therapy program combined with pulley therapy for muscle strengthening.

Group B Treatment:

- Designed physical therapy program combined with functional electrical stimulation during walking on a treadmill for muscle stimulation.

The interventions in both groups aim to improve muscle strength, range of motion, and functional abilities in children with cerebral palsy.

详细描述

B)For assessment:

  1. Assessment of muscle strength
  • In this study, Lafayette manual muscle tester device will be used to assess muscle strength of hamstrings and tibialis anterior muscles.
  • Test procedures will be demonstrated to each child.
  • For both tests each child will perform three corrected trials and the average will be taken in analysis.

For tibialis anterior muscle:

Each child will be lied supine with feet relaxed on the plinth. Hips knees will be in extension and neutral rotation. Each child will be stabilized by straps at pelvis and just above knees, then the examiner will place the device in his hand and put it on the dorsum aspect of examined foot over the metatarsal heads and ask the child to take his/her foot toward him the device

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
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Their age will be ranged from four to eight years.
  • •Their grade of spasticity will be from 1 to 1+ according to Modified Ashworth scale
  • •They will be on Level I and II according to Gross Motor Functional Classification System (GMFCS)
  • •The child will be able to follow verbal commands and instructions.

排除标准

  • •- The children will be excluded if they have one of the following:
  • •Previous neurological or orthopedic surgery in the lower extremities.
  • •Botox injection in the lower extremities in the past 6 months. 4-Fixed deformity in the joints of lower limb.
  • •5- Genu recarvatum secondary to surgery 6- Severe hearing and visual defect.

研究组 & 干预措施

effect of universal exercis unit on genu recurvatum in diplegic cerbral palsy children

Active Comparator

Universal exercise unit (UEU) consists of system of pulleys, suspensions, belts for supporting and elastic cords. UEU is based on the concept of unloading the body against gravity and to perform movement of weak part of the body. Therapist's hands are free to provide adequate support as required by the patient during exercise training Universal exercise unit, therapy sessions extended are from three to four hours Children and adults have neurological conditions can used. Spider cage is made of metal could be depending on population pediatric or adults. Elastic resistance of cords used to increase strengthen of muscle

干预措施: universal exercis unit (Device)

effect of functional electrical stimulation on genu recurvatum in diplegic cerbral palsy children

Active Comparator

Functional electrical stimulation (FES) is defined as the electrical stimulation of muscles that have impaired motor control to produce a contraction to obtain functional useful movement

干预措施: functional electrical stimulation (Device)

结局指标

主要结局

Range of motion using kinoviea software and digital goniometer

时间窗: 3 months

\- Kinovea is a free 2D motion analysis software that enables the establishment of kinematics parameters. This low-cost technology has been used in sports sciences, as well as clinical field and research work. Kinovea is a free, reliable tool that produces valid data, providing an acceptable level of accuracy in angular and linear measurements obtained via digitization of x- and y axis coordinates an angle measured in degrees (°)through which a joint moves away from a reference position

muscle strength using muscle tester device

时间窗: 3 months

Muscle strength can be measured by estimating a person's one repetition maximum (1RM) - a measurement of the greatest load (in kg) that can be fully moved (lifted, pushed, or pulled) once without failure -For both tests each child will perform three corrected trials and the average will be taken in analysis

range of motion for the joint using digital geniometer

时间窗: 3 months

measure the angle of the joint by degree (°)

次要结局

未报告次要终点

研究者

发起方
Mahmoud Reda Elsharkawy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mahmoud Reda Elsharkawy

Demonstrator of pediatric department of physical therapy at Alsalam university

Kafrelsheikh University

研究点 (1)

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