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临床试验/NCT05042570
NCT05042570Unknown不适用

The Effect of Instrument Assisted Soft Tissue Mobilization and Stretching Exercises on Flexibility, Spasticity and Balance in Individuals With Cerebral Palsy

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 39 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
39
试验地点
2
主要终点
Selective Motor Control Test (SMCT)

研究概览

简要总结

The aim of the study; To investigate the effects of Instrument Assisted Soft Tissue Mobilizations and Stretching Exercises on flexibility, spasticity, balance and functional mobility in patients with CP.

详细描述

Various intervention studies; reported positive results with EDYDM after carpal tunnel syndrome, myofascial trigger point, chronic low back pain, nonspecific thoracic spine pain, ankle instability, mastectomy and total joint arthroplasty. Observational studies have shown positive results in improving posterior shoulder range of motion, hip, knee, and ankle ROM.

There is no study in the literature with EDYDM in patients with CP. Many of the problems in which EDDM is applied for fascia and muscle mobilization in different diseases are also seen in patients with CP. In current rehabilitation methods, Stretching Exercises are applied for muscle and fascia shortening. The advantages of the applications over each other are unknown. Our study is planned as a study with high original value as it is the first study to be conducted using EDYDM in cases with CP. In our study, the effectiveness of EDYDM treatment, which will increase the effectiveness of stretching exercises in CP or can be an alternative treatment approach in cases with CP, will be compared with Stretching Exercises.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Having been diagnosed with Unilateral Spastic Type Cerebral Palsy by the health committee report,
  • Level I or II according to GMFCS,
  • Being between the ages of 5-18,
  • No Botulinum Toxin (Botox) injection in the last 6 months,
  • Not using any medication that may affect muscle tone,
  • Passive ankle dorsiflexion + 10o and passive plantar flexion -25o,
  • Families and children agree to participate voluntarily in the study.

排除标准

  • Having undergone any lower extremity surgery,
  • Tone in plantar flexors is level IV according to MAS,
  • Presence of advanced contracture in the ankle,
  • Presence of any diagnosed cardiac or orthopedic disorder that may prevent the application of the treatment,
  • Hearing or vision problems,
  • Having a history of epileptic attacks,
  • Not having the ability to adapt to exercises (cases with the phrase "Mental Retarde" according to the health report).

结局指标

主要结局

Selective Motor Control Test (SMCT)

时间窗: one month

Ankle dorsiflexion Selective Motor Control Test will be used in the evaluation of selective movements. This test evaluates the isolated dorsiflexion movement of the ankle and is evaluated between 0-4 according to the selectivity of the ankle dorsiflexion movement in the long sitting position.

Modified Ashworth Scale (MAS)

时间窗: one month

In the evaluation of the presence of spasticity in patients with CP, the ankle plantar flexors will be based. It is recorded as an assessment of the resistance encountered while passively moving the limb at full range of motion. It is scored as 0, 1, 1+, 2, 3, 4. A value of 0 is the best score without muscle tone increase, while a value of 4 is when the extremity is in a rigid position. Modified Ashworth Scale (MAS) will be used to evaluate spasticity.

Pediatric Berg Balance Scale (PBBS)

时间窗: one month

The Pediatric Berg Balance Scale, which is the version of the Berg Balance Scale designed for children by Franjoine et al., will be used to evaluate their functional balance in activities of daily living. The scale consists of 14 sections and each section is scored between 0-4; The highest score that can be obtained from the scale is 56.

Weight-Bearing Lunge Testi (WBLT)

时间窗: one month

In order to measure the weight-bearing dorsiflexion ROM, the Weight-Bearing Lunge Test, which is positioned with support from the wall in the closed chain position, will be applied. An increase in ankle dorsiflexion angle will be considered as a positive result.

次要结局

未报告次要终点

研究者

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

Eren Avcıl

Principal Investigator

Istanbul University - Cerrahpasa

研究点 (2)

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