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Completed

NCT Number: NCT03703011

Accelerometers' Validity in Counting Number of Steps in the Elderly Subjects Before Discharge From Rehabilitation Units

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.

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Key information

Conditions

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Bicêtre - Geriatric Department

Le Kremlin-Bicêtre, 94270, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Accelerometers positioned at the wrinkle, the hip, and the ankle

Device

Accelerometers are positioned at the wrinkle, the hip, and the ankle. The subject stands and walks 10 meters, followed up by a physiotherapist in the physiotherapy area. The accelerometers are triggered by a smartphone. The protocol is filmed (without the face), and 2 physicians will watch the film and count the steps blind to the results of the accelerometers (and blind to each-other steps counts)

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. 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.

    Time frame: 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. Comparison between number of steps measured by the accelerometers worn on the ankle and the number of steps counted by the physicians visioning the film.

  2. 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.

    Time frame: 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. Comparison 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. 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).

    Time frame: 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. Comparison of the best matching between the number of steps evaluates by accelerometers worn on the hip, the ankle and the wrist and the number of steps counted by the physicians visioning the film.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: VAPODAGE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 11, 2018
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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