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临床试验/NCT02485171
NCT02485171已完成不适用

Post-fall Syndrome of the Aged Person : Contribution of SAFEWALKER for Rehabilitation

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年6月10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
20
试验地点
2
主要终点
Acceptability of Safewalker

研究概览

简要总结

The main objective of this study is to evaluate the feasibility and acceptability of the use of the robot "SAFEWALKER" complement classical rehabilitation in a group of elderly patients over 70 years during the rehabilitation of post-fall syndrome.

详细描述

The post-fall syndrome is an acute functional complications of falls that affects nearly one in five elderly fallers. It combines phobia of the previous vacuum, axial and hypertension astasia abasia.

Unrecognized and untreated, it progresses to a major regressive syndrome, severe physical, psychological and social implications. Only an early rehabilitation for an early resumption of walking, prevents such a development.

The main element is to support and encourage the subject to walking. In practice, it was found that the physiotherapist can not be present daily and the duration of its intervention is often short-lived.

This study will examine the contribution of a medical device of a walking aid (SAFEWALKER the robot) in the rehabilitation and empowerment of seniors with a post-fall syndrome. The SAFEWALKER, which is a walking aid device (http://www.safewalker.com), completes the support action exercised by a third person, by reducing support and securing travel. It allows the subject to move alone at will and is a continuity in relation to the management of the physiotherapist, a potential source of motivation.

The hypothesis is that the SAFEWALKER device can be complementary to the walking rehabilitation in post-fall syndrome.

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
None

入排标准

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

入选标准

  • Patients hospitalized for the treatment of post-fall syndrome

排除标准

  • Demential pathology (Mini Mental State <20)
  • Parkinson's disease and other degenerative neurological disorders
  • Stroke sequelae
  • Fractures members in the previous 12 months
  • Lower limb prostheses in place within 6 months prior
  • Psychiatric disease
  • Presence of mucocutaneous lesions perineal
  • Obesity (weight >120 kg)

结局指标

主要结局

Acceptability of Safewalker

时间窗: Day 14

A composite measure based on questionnaires assessing the acceptability (patient and therapist).

Feasibility of Safewalker

时间窗: Day 14

Number of steps performed at each of the rehabilitation sessions A composite measure based on questionnaires assessing the feasibility (patient and therapist).

次要结局

  • Number of falls during the study(Day 14)
  • Step length(Day 14)
  • Quality of life(Day 14)
  • Independence in basic activities of daily living(Day 14)
  • The fear of falling(Day 14)
  • Walking speed(Day 14)
  • Retropulsion degree(Day 14)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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