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临床试验/NCT04353167
NCT04353167已完成不适用

Examination of the Relationship Between Foot - Body Posture and Balance and Gait in Duchenne Muscular Dystrophy

Hacettepe University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年3月15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
38
试验地点
1
主要终点
Gait instrumented walkway (GaitRite)

研究概览

简要总结

Foot and body postures of patients with DMD will be evaluated. Foot structure characteristics such as foot length, metatarsal width, calcaneal valgus angle will be calculated for the foot posture. Also, the Foot Posture Index (FPI-6) scale will be used. The body posture will be evaluated with the New York Posture Scale. Many gait characteristics such as step length, cadence, support surface of the patients will be determined with GaitRite instrumented walkway. Patients' balance assessment will be evaluated with Bertec Balance Advantage. The statistical analysis method will determine the relationship between foot and body posture and gait and balance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 13 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • To be between 5-13 years old
  • Being at level I or II according to Brooke Lower Extremity Functional Classification Scale
  • In the balance assessment, there should be at least 90 degrees of joint range of motion in the ankle to provide base contact on the force platform.
  • Agree to participate in the research voluntarily

排除标准

  • Having serious mental and psychological problems,
  • Failure to cooperate adequately with the physiotherapist making the evaluations,
  • Severe contracture in lower extremities,
  • Any injury and / or surgery of the lower extremities in the past 6 months.

结局指标

主要结局

Gait instrumented walkway (GaitRite)

时间窗: 10 minutes

The GAITRite® system mat was positioned on the floor and connected to a laptop computer, with a 2 m acceleration/deceleration walkway at either end. Subjects were asked to walk at their typical speed to the designated end of the walkway.

Bertec Balance System (Bertec)

时间窗: 10 minutes

The system consists of a 20 × 20-inch platform at ground level connected to a laptop computer. The balance plate detects body sway based on the pressure that the subject's feet apply to the plate surface. For testing, each subject stood for 10 seconds under 4 different testing conditions. The first two conditions were eyes open and eyes closed on the balance plate itself, defined as normal stability - eyes open (NSEO) and normal stability - eyes closed (NSEC). These were followed by the patient standing on a 4-inch thick foam rubber pad while on the balance plate. These were labeled as perturbed stability - eyes open (PSEO) and perturbed stability - eyes closed (PSEC). The primary measure assessed by the balance plate for each condition was maximum center of pressure excursion or COP (a distance measured in inches of the major axis of an ellipse calculated along the axis of maximum excursion).

次要结局

  • Foot Posture Index - 6(10 minutes)
  • NewYork Posture Scale(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Güllü AYDIN YAĞCIOĞLU

Principal Investigator

Hacettepe University

研究点 (1)

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