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Accelometers' Validity in Counting Number of Steps in the Elderly Subjects Before Discharge From Rehabilitation Units (VAPODAGE)

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ClinicalTrials.gov Identifier: NCT03703011
Recruitment Status : Not yet recruiting
First Posted : October 11, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Accelometers 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. Our objective was to assess accelometers' validity for counting steps (10 meters), in comparison with the gold standard: steps counted by 2 physicians blind to accelometers data, over a filmed 10-meter walk (minimal capacity to walk inside their own living place). Our second objective was to evaluate the best position of the accelometer: wrist, ankle, hip.

Condition or disease Intervention/treatment Phase
Geriatrics Device: Accelometers positioned at the wrinkle, the hip, and the ankle Not Applicable

Detailed Description:

Accelometers enhance physical activity. Only one study assessed accelometers' validly in an elderly robust population, over 100m walking distance. The accelometers' validly was demonstrated especially for the ankle position (Floegel et al., 2017). Our primary objective was to assess accelometers 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 accelometers data, over a filmed 10-meter walk (minimal capacity to walk inside their own living place). Our second objective was to evaluate the best position of the accelometer: wrist, ankle, hip.

We 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. Our secondary objective was to evaluate the position of the accelometer 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 accelometers. To eliminate measurement bias, Bland Altman analysis will be performed. Interclass correlation will be performed to measure the differences between accelometers' 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Accelometers' 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 Accelometer Positions: Wrist, Ankle, Hip
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Interventional
Subjects aged >70 years, hospitalized in the rehabilitation geriatric ward in the Paul Brousse hospital, France, able to walk 10 meters, ready to be discharged, and a Mini mental state examination ≥ 20/30
Device: Accelometers positioned at the wrinkle, the hip, and the ankle
Accelometers 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 accelometers 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 accelometers (and blind to each-other steps counts)




Primary Outcome Measures :
  1. Matching between number of steps measured by the accelometers 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 Outcome Measures :
  1. Matching between number of steps measured by the accelometers 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 accelometers 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 accelometers 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. Comparaison between number of steps measured by the accelometers 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 accelometers and the the number of steps counted by the physicians visioning the film according to the accelometers 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. Comparaisonof the best matching between the number of steps evaluates by accelometers worn on the hip, the ankle and the wrist and the number of steps counted by the physicians visioning the film.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703011


Contacts
Contact: Emmanuelle DURON, Md, PhD +33145596943 emmanuelle.duron@aphp.fr

Locations
France
Hopital Bicêtre - Geriatric Department Not yet recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Emmanuelle DURON, Dr    014556943 ext +33    emmanuelle.duron@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Emmanuelle DURON, Md, PhD APHP,Paul Brousse Hospital

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03703011     History of Changes
Other Study ID Numbers: 17004
2018-A00348-47 ( Other Identifier: French Health Products Safety Agency )
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
geriatrics
discharge
Accelometers