NCT01522690

Brief Summary

The objective of this study is to obtain normative accelerometry data during the six minute walk test and a 30 second walk test on healthy subjects in order to determine the accelerometric variables that are the most relevant to describe gait disorders in patient populations. Secondary objectives of this study are to investigate the impact of walking speed and muscle strength on the accelerometric parameters, to assess the reproducibility of the method and to compare accelerometric data obtained with two different devices.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable healthy

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

Study Start

First participant enrolled

December 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

4 years

First QC Date

January 4, 2012

Last Update Submit

April 14, 2016

Conditions

Healthy

Keywords

Accelerometergait analysisHealthy subjects

Outcome Measures

Primary Outcomes (2)

  • Accelerometric variables measured for each walk test

    At baseline

  • Accelerometric variables measured for each walk test

    1 hour after baseline

Secondary Outcomes (3)

  • Gait speed measured for each walk test

    At baseline

  • Knee flexion and extension strength

    At baseline

  • Gait speed measured for each walk test

    1 hour after baseline

Interventions

Different walk tests with an accelerometer deviceOTHER

Subjects will performed three walk tests of 50 meter at different speeds, a six minute walk test, a walking test of 30 seconds then a test to measure the maximum force of extension and knee flexion on each leg. The walk tests will be performed with the accelerometer device (Locometrix) worn in a belt

Eligibility Criteria

Age5 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • healthy ambulant subject
  • subject affiliated to a social security system
  • subject who signed an informed consent

You may not qualify if:

  • surgery or recent trauma to the lower limbs (under 6 months)
  • high performance sport
  • pregnant or nursing woman
  • person under guardianship or curatorship
  • orthopedic, neuromuscular or neurological disease having an impact on the quality of walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Myologie - GH Pitié Salpêtrière

Paris, Paris, France

Location

Study Design

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

Study Record Dates

First Submitted

January 4, 2012

First Posted

February 1, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

FR(1)