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临床试验/NCT04180124
NCT04180124已完成不适用

Movement Analysis of Stroke Patients When Walking on a Treadmill

University Ghent2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年1月6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
25
试验地点
2
主要终点
Change in kinematics

研究概览

简要总结

In daily clinic, the use of treadmills to analyze the gait quality of a patient increases. The advantages of using a treadmill are that a smaller space is needed compared to a 3D lab for motion analysis, more steps can be recorded in shorter time period and patients should not start, stop or rotate during the analyses. One of the systems which can be used to perform motion analysis on a treadmill is the GRAIL. This GRAIL (Gait Real-time Analysis Interactive Lab) consists of an advanced treadmill with force sensors. Patients can walk on this treadmill with an imposed speed (fixed-speed) or at a speed determined by the patient itself (self-paced). Because not everyone is used to walk on a treadmill it is important to know if a person's walking pattern is different when he walks over ground compared to walking on the treadmill. Based on these insights, decisions can be made regarding interventions including treadmill training or this findings can be taking into account during further analysis of walking patterns on a treadmill. For this study stroke patients would be invited for an assessment on the treadmill (1 assessment moment). The movement pattern of these patients would be compared in different conditions:

  • (Forward and backward) Walking at comfortable walking speed on the GAITRite
  • Walking at comfortable walking speed on the treadmill in fixed speed mode
  • Walking at comfortable walking speed +0.2 m/s (faster walking) on the treadmill in fixed speed mode
  • Walking at comfortable walking speed on the treadmill in self-paced mode
  • Backward walking at comfortable walking speed on the treadmill in fixed speed mode (only if patients are eligible to do so)

Hypotheses based on this study protocol:

  • Do stroke patients walk different over ground compared to treadmill walking
  • Do stroke patients walk different during treadmill walking self-paced compared to fixed speed
  • Do stroke patients walk different during treadmill walking fixed speed comfortable walking speed compared to fast walking
  • Is there a correlation between upper extremity impairment and arm swing

研究设计

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

入排标准

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

入选标准

  • Stroke patients with the ability to walk without walking devices for 6 minutes without rest (indoor walking). Use of AFO is allowed if necessary.

排除标准

  • Traumatic brain lesions (car accident, fall with bike, ...)
  • Other disorders such as neurologic, musculoskeletal, respiratory or severe cardiovascular disorders that affected gait performance
  • Bilateral stroke
  • Cerebellar stroke
  • Orthopedic surgery lower limbs in the past
  • Cognitive or language impairments that prevent the patients from understand simple orders

结局指标

主要结局

Change in kinematics

时间窗: Single point of assessment in one day

Change in full body 3D kinematic analyses during walking (°)

Change in kinetics

时间窗: Single point of assessment in one day

Change in full body 3D kinetic analyses during walking

次要结局

  • Postural stability test(Baseline assessment before walking trials)
  • Fugl Meyer assessment UL(Baseline assessment before walking trials)
  • Fugl Meyer assessment LL(Baseline assessment before walking trials)
  • Speed variability during self-paced treadmill walking(Single point of assessment in one day)
  • Lateral rotation of the scapula(Baseline assessment before walking trials)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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