跳至主要内容
临床试验/NCT03703011
NCT03703011已完成不适用

Accelerometers' Validity in Counting Number of Steps in the Elderly Subjects Before Discharge From Rehabilitation Units, Having Reached Their Maximal Walking Ability After Physiotherapy. Comparison of the Accuracy of 3 Accelerometer Positions: Wrist, Ankle, Hip

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年3月1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
120
试验地点
2
主要终点
Matching between number of steps measured by the accelerometers and the number of steps counted by the physicians visioning the film.

研究概览

简要总结

Accelerometers enhance physical activity. Nevertheless, their validity (ability to accurately count steps) is not known in an elderly frail population ready for discharge from a rehabilitation unit. The objective was to assess accelerometers' validity for counting steps (10 meters), in comparison with the gold standard: steps counted by 2 physicians blind to accelerometers data, over a filmed 10-meter walk (minimal capacity to walk inside their own living place). The second objective was to evaluate the best position of the accelerometer: wrist, ankle, hip.

详细描述

Accelerometers enhance physical activity. Only one study assessed accelerometers' validly in an elderly robust population, over 100m walking distance. The accelerometers' validly was demonstrated especially for the ankle position (Floegel et al., 2017). The primary objective was to assess accelerometers validity for counting steps in an elderly frail population ready for discharge from a rehabilitation unit. The comparison gold standard was steps count by 2 physicians blind to accelerometers data, over a filmed 10-meter walk (minimal capacity to walk inside their own living place). The second objective was to evaluate the best position of the accelerometer: wrist, ankle, hip.

Investigators included prospectively subjects aged ≥ 70 years, hospitalized in the Paul Brousse geriatric rehabilitation ward, able to walk at least 10 meters (maximum functional recovery according to the physiotherapist opinion) and with a Mini mental state examination ≥ 20/30 (able to understand). All subjects gave written informed consent and the study was approved by the local ethics committee. The secondary objective was to evaluate the position of the accelerometer that give the most accurate step count: wrist, ankle, hip. The study took place in the Paul Brousse hospital in Villejuif in rehabilitations units. Falls during the protocol were considered as the only risk. To prevent this risk a physiotherapist walked behind the participants during the 10-meter walk. Demographic, clinical, physiological data were recorded and anonymized. In this monocentric non-randomized study, the number of participants to include was 120. Twenty participants were planned to be included each month during 6 months. Statistical analysis will be made by a T test to measure the difference between the gold standard and the count of the accelerometers. To eliminate measurement bias, Bland Altman analysis will be performed. Interclass correlation will be performed to measure the differences between accelerometers' positions. Logistic regressions will be done with measurement's variability determinants. In all analyses, the 2-sided α-level of 0.05 was used for significance testing.. All analysis will be performed using R statistical software.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Age> 70 years
  • Patients able to walk 10 meters,
  • Maximum functional recovery obtained according to the physiotherapist judgment and ready for discharge,
  • Patients able to understand the instructions and to freely consent (Mini mental state examination ≥ 20/30 and score at the consent scale: UBACC≥ 12/20)
  • Written consent
  • Unprotected adult
  • Covered by health insurance
  • Non inclusion Criteria:
  • Impossibility to walk the required distance (severe dyspnea, post fall syndrome, blindness, ..)
  • Patients participating in another interventional research.

排除标准

  • 未提供

结局指标

主要结局

Matching between number of steps measured by the accelerometers and the number of steps counted by the physicians visioning the film.

时间窗: 3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.)

A step is counted when a foot touches the ground

次要结局

  • Best matching between the number of steps evaluated by the accelerometers and the the number of steps counted by the physicians visioning the film according to the accelerometers positions (hip, ankle, wrist).(3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.))
  • Matching between number of steps measured by the accelerometers worn on the ankle and the number of steps counted by the physicians visioning the film.(3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.))
  • Matching between number of steps measured by the accelerometers worn on the wrist and the number of steps counted by the physicians visioning the film.(3 days maximum (The 10-meter walk test is conducted within 3 days of signing the consent.))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验