NCT03703011

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
Last Updated

November 19, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

October 9, 2018

Last Update Submit

November 18, 2019

Conditions

Geriatrics

Keywords

geriatricsdischargeAccelerometers

Outcome Measures

Primary Outcomes (1)

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

    A step is counted when a foot touches the ground

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

Secondary Outcomes (3)

  • 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.)

  • 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.)

Study Arms (1)

Interventional

EXPERIMENTAL

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

Interventions

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

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)

Interventional

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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
  • Impossibility to walk the required distance (severe dyspnea, post fall syndrome, blindness, ..)
  • Patients participating in another interventional research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Bicêtre - Geriatric Department

Le Kremlin-Bicêtre, 94270, France

Location

Study Officials

  • Emmanuelle DURON, Md, PhD

    APHP,Paul Brousse Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 11, 2018

Study Start

March 1, 2019

Primary Completion

August 29, 2019

Study Completion

August 29, 2019

Last Updated

November 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)