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临床试验/NCT04273204
NCT04273204已完成不适用

Does One-Leg-Standing Duration Have a Relationship With Gross Motor Function Measurement Scores and Stance Phase for Unilateral Spastic Children

Istanbul Kültür University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2018年1月10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
28
试验地点
1
主要终点
One leg standing test (OLST)

研究概览

简要总结

The primary aim of this study was to investigate the relationship between the One Leg-Standing Test (OLST) and the Gross Motor Function Measurement (GMFM) and stance phase stability during gait in Unilateral Cerebral Palsy (UCP). The secondary aim was to explore a new well-defined pedobarographic parameter as a functional factor in the stability of stance in gait.

The investigator's hypotheses are (1) OLST has relationship between T2-T1 in children with UCP; (2) OLST has relationship between GMFM D and E.

Eighteen children with UCP and ten typically developing children (TDC) participated in the study. All participants and their legal guardians signed an informed consent form before participating. Firstly, to asses the stability in stance all participants were analyzed by using pedobarographic analysis and the OLST. After analysis, only the UCP group was evaluated with the GMFM. The TDC group was used for comparison of pedobarographic stance phase stability (T2-T1) and OLST values.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •(for experimental group):
  • •diagnosed unilateral cerebral palsy
  • •be able to stand on the affected leg for 0 to 30 seconds

排除标准

  • •Children with UCP who had Botulinum Toxin-A injections to the lower limbs in the previous six months
  • •Lower limb surgeries
  • •Mental disorders

研究组 & 干预措施

UCP Group

Experimental

干预措施: one leg standing test, gross motor function measurement, pedobarographic measurement (Diagnostic Test)

Control Group

Other

干预措施: one leg standing test, gross motor function measurement, pedobarographic measurement (Diagnostic Test)

结局指标

主要结局

One leg standing test (OLST)

时间窗: 1 time, baseline of the study

During the OLST, the participants were asked to shoes off, place both hands on their hips and look at a point on the wall at eye level. A recording stopwatch was used to assess their standing duration on one leg while keeping the other leg in 90 degrees of knee flexion. The test was stopped when the contralateral foot touched the ground or when the participant broke 90 degrees of knee flexion. The OLST was repeated three times for each leg and the best score was chosen.

Gross Motor Function Measurement (GMFM)

时间窗: 1 time, baseline of the study

The Gross Motor Function Measure (GMFM) is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy. Items span the spectrum of gross motor activities in five dimensions. A: Lying and Rolling, B: Sitting, C: Crawling and Kneeling, D: Standing, and E: Walking, Running and Jumping. In our study, To assess standing and walking, running and jumping functions of the UCP group (GMFCs level I and II), the D and E dimensions of GMFM were utilized by a certificated physiotherapist. Each item was tested by three trials and the best trial was scoring between 0-3 points.

Pedobarographic Measurement

时间窗: 1 time, baseline of the study

The participants' plantar pressure was analyzed using pedobarography (Tekscan Inc. Mass. USA) with rectangular shape plates (43.59 x 36.88 x 5.77 cm) and 2288 resistive pressure sensors. For each participant, the pedobarography was calibrated before the assessment. During the pedobarographic analysis, the participants walked barefoot in 90 BPM cadence with the aid of a metronome. Before the pedobarographic analysis, each participant walked three minutes to adapt to the metronome.Three steps were analyzed for each side (affected and unaffected sides) to evaluate the following parameters i) time of peak force in early stance phase (T1), ii) time of peak force of late stance phase (T2), iii) stance phase stability (T2-T1), iv) duration of total stance phase (TS) and v) ratio (T2-T1/TS). A mean value of each parameter was used for statistical analysis.

次要结局

未报告次要终点

研究者

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

Gamze Ertürk

Research assistant

Istanbul Kültür University

研究点 (1)

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