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临床试验/NCT03285919
NCT03285919已完成不适用

Feasibility of Perturbed-balance Training During Treadmill Walking in a High-functioning Chronic Stroke Subject: a Case-control Study

University Rehabilitation Institute, Republic of Slovenia2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2016年12月5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
入组人数
2
试验地点
2
主要终点
Change in centre of mass of the Case

研究概览

简要总结

A control and a post-stroke subject with right-side chronic hemiparesis were studied. The post-stroke subject underwent 30 sessions of balance-perturbed training while walking on an instrumented treadmill where the Balance Assessment Robot (BAR™) randomly delivered pushes to pelvis in various directions at various speeds and at various perturbation amplitudes. The investigators assessed kinematics, kinetics, electromiography and spatio-temporal responses to outward-directed perturbations commencing either at foot contact of the left or the right leg.

详细描述

For a detailed description of the study, see the Arms and Interventions section.

研究设计

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

入排标准

性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Case - stroke survivor

Experimental

Stroke survivor, 6mon post stroke resulting in right-sided hemiparesis, 53yrs old, had completed a 2mon rehabilitation program prior to the study. He underwent 30 training sessions with the Balance Assessment Robot (BAR™) within a 10-week period, each consisting of 10-15min of unperturbed treadmill and 30-45min of perturbation training. Perturbations were delivered in the forward, backward, left and right direction, occurring every 6sec, at the left leg initial contact and the right leg initial contact. Two training sessions were spent to determine adequate treadmill speed (0.4m/s) and perturbation amplitude (60N), followed by the first assessment session. After the last training session, assessment was repeated using the same parameters plus 90N perturbation amplitude.

干预措施: Balance Assessment Robot (BAR™) (Device)

Control - matched healthy subject

Active Comparator

Healthy male, height- and weight-matched to the Case. He was assessed according to the same protocol as the Case using the Balance Assessment Robot (BAR™) at perturbation amplitudes 60 and 90 N.

干预措施: Balance Assessment Robot (BAR™) (Device)

结局指标

主要结局

Change in centre of mass of the Case

时间窗: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)

For the purpose of qualitative assessment of kinematics and kinetics

Change in centre of pressure of the Case

时间窗: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)

For the purpose of qualitative assessment of kinematics and kinetics

Change in ground reaction force of the Case

时间窗: Assessment at session no. 3 (during week 1) and session no. 30 (during week 10)

For the purpose of qualitative assessment of kinematics and kinetics

次要结局

  • Centre of pressure of the Control(During the only session (i.e., session 1 on day 1))
  • Centre of mass of the Control(During the only session (i.e., session 1 on day 1))
  • Ground reaction force of the Control(During the only session (i.e., session 1 on day 1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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