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临床试验/NCT05535374
NCT05535374招募中不适用

Validity of Using Connected Soles In Measuring Steps Number In the Older Subject, Hospitalized in Follow-up and Rehabilitative Care and Achieve Its Rehabilitation Objectives

Gérond'if1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Assessment of the concordance of the step count between the connected soles and the video

研究概览

简要总结

The purpose of this study is to evaluate counting steps by connected soles worn in the shoes of subjects, having recovered the maximum walking capacities of patients . To answer the question asked in the study, it is planned to include 60 patients over 70 years of age.

详细描述

The main objective of this interventional, monocentric, transverse, nonrandomized and prospective study is to assess the concordance of step counting between connected soles and video, in elderly subjects hospitalized in Follow-up and rehabilitation care, at Paul Brousse hospital, having recovered maximum walking capacities of participants, on 10 meters. After inclusion, following data will be collected : Measure blood pressure, heart rate, neurological and cardiological exam, pneumological exam, Short Physical Performance Battery Score Feetme connected soles comply with European standards (CE label no. 29762). The study will consist of 10-metre walk for patient during a rehabilitation session :

  • By wearing the soles connected to patient's size (in patient's usual shoes). The recording of data will be triggered by an investigator, via an application downloaded on a smartphone. The application will trigger and stop the registration of soles.
  • While being filmed by a camcorder mounted on a tripod (excluding the face) for footsteps. The test will be filmed (excluding the face) to avoid a measurement bias in counting steps. Two physician observers will view each patient's film in a second time in order to perform the step count. Before starting the walk, an on-site observer will ensure that the footings are set to 0 for counting step and that the recording is stopped after 10 metres. If this is deemed possible by the referring physiotherapist, the same protocol will then be carried out over 30 meters (new test: the patient who can do it will perform 40 meters in total (10 meters then test of 30 meters).

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

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

入选标准

  • •Age >70 years olde
  • •Patients able to walk 10 meters
  • •Patients who received physiotherapy
  • •Patients able to understand instructions and freely consent (mini mental state examination (MMSE) ≥ 20
  • •Informed consent, major unprotected
  • •Membership in a social security scheme

排除标准

  • •Unable to walk the required distance (severe dyspnea, post-fall syndrome, blindness)
  • •Foot sores (bedsores or other)
  • •Patients participating in another intervention study
  • •Major patients protected or deprived of study freedom

研究组 & 干预措施

Connected soles

Experimental

Number of steps recorded by the soles (activation per smartphone)

干预措施: Feetme Connected Soles (Device)

Gold Standard

Active Comparator

Number of steps counted by two observers viewing the film

干预措施: Feetme Connected Soles (Device)

结局指标

主要结局

Assessment of the concordance of the step count between the connected soles and the video

时间窗: 3days

The main evaluation criterion is the number of steps taken by the patient to travel the distance of 10 meters. A ground marking will be done using a tape meter to highlight the distance of 10 meters.The number of steps will be counted using the connected soles and video.

次要结局

  • Assessment of steps number to cover the distance of 30 meters according connected soles and video(3 days)
  • Assessment of soles comfort according Likert scale(3 days)

研究者

发起方
Gérond'if
申办方类型
Other
责任方
Sponsor

研究点 (1)

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