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临床试验/NCT07116798
NCT07116798招募中不适用

Investigation of the Effects of Different Upper Extremity Strengthening Exercises in Children With Unilateral Spastic Type Cerebral Palsy

Biruni University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
14
试验地点
2
主要终点
Muscle Thickness Measurement by Ultrasonography

研究概览

简要总结

This study aims to compare the effects of two different upper extremity strengthening exercise approaches-bilateral strengthening exercises based on Proprioceptive Neuromuscular Facilitation (PNF) patterns and plyometric exercises-on muscle thickness, joint range of motion, muscle strength, and functional performance in children with unilateral spastic cerebral palsy (USCP). Although strengthening exercises targeting the affected upper limb in children with USCP have been investigated in numerous studies, to our knowledge, no previous research has directly compared the effects of bilateral PNF-based strengthening exercises and plyometric training. Incorporating PNF patterns into upper extremity rehabilitation programs has been previously recommended, and examining the efficacy of these exercises in comparison with plyometric training may contribute valuable insights to the literature and inform clinical practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double blinded

入排标准

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

入选标准

  • Aged between 5 and 12 years
  • Diagnosed with unilateral spastic type cerebral palsy
  • Classified as Level I or II according to the Gross Motor Function Classification System (GMFCS)
  • Classified as Level I or II according to the Manual Ability Classification System (MACS)
  • Upper extremity muscle tone ≤2 on the Modified Ashworth Scale
  • Willing to suspend other upper extremity therapeutic interventions during the study period
  • Able to cooperate and follow instructions provided by the researcher
  • Voluntarily willing to participate in the study

排除标准

  • History of any upper extremity surgery or Botulinum toxin (Btx) injection within the past 6 months
  • Presence of an additional neurological disorder other than cerebral palsy
  • Having visual and/or hearing impairments
  • Having severe contractures that limit participation in functional activities

结局指标

主要结局

Muscle Thickness Measurement by Ultrasonography

时间窗: Baseline and after 8-weeks

Ultrasonographic measurements will be performed using the Esaote Mylab 60 device with a linear probe. Muscle thickness will be assessed in the upper trapezius, rhomboid major, anterior deltoid, lateral triceps brachii, long head of biceps brachii, extensor carpi radialis brevis, extensor digitorum communis, and flexor digitorum superficialis. Measurements will be taken with the elbow flexed at 70°, in standardized resting positions, with forearm in pronation or supination depending on the muscle group. To ensure reliability, three separate images per muscle will be taken, with the probe repositioned each time. Anatomical landmarks will be palpated and marked. Muscle thickness will be measured as the distance between the subcutaneous fat-muscle and muscle-bone interfaces.

Range of Motion Assessment

时间窗: Baseline and after 8-weeks

Joint range of motion (ROM) will be assessed before and after treatment using a universal goniometer. Active ROM measurements will include shoulder flexion and abduction (measured in standing), elbow flexion and extension (in supine), and forearm pronation-supination and wrist flexion-extension (in sitting). Movements will first be demonstrated on the unaffected limb, then performed with the affected limb. Active ROM values will be recorded. Each movement will be measured three times, and the mean value in degrees will be documented. Measurements will follow Kendall-McCreary criteria to ensure standardization and accuracy.

Muscle Strength Assessment

时间窗: Baseline and after 8-weeks

Muscle strength of shoulder flexion-abduction, elbow flexion-extension, forearm pronation-supination, and wrist flexion-extension will be assessed before and after treatment using a hand-held dynamometer (HOGGAN microFET2). A towel will be placed between the limb and device to ensure full contact and minimize sensitivity caused by surface hardness. The "make method," accepted for pediatric use, will be applied: the physiotherapist will ask the child to push maximally against the fixed device. The test will first be demonstrated on the unaffected limb. Two practice trials will be conducted on the affected side to ensure comprehension, followed by three test measurements. A rest interval will be given between trials. The mean of the three tests will be recorded in kilograms (kg).

次要结局

  • Quality of Upper Extremity Skills Test-QUEST(Baseline and after 8-weeks)
  • ABILHAND- Kids(Baseline and after 8-weeks)

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gülsena Utku Umut

Assisstant Professor

Biruni University

研究点 (2)

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