Assessment of Accelerometric Measurement Devices for Gait... | NCT01522690

Studies
Assessment of Accelerometric Measurement Devices for Gait Analysis

NCT01522690

Sponsor

Institut de Myologie, France

Status

Completed

Last Update Posted

Apr 15, 2016Estimated

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

Different walk tests with an accelerometer device

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Jan 4, 2012

First Submission Date that Met QC Criteria

Jan 27, 2012

First Posted Date

Feb 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2016

Last Update Posted Date

Apr 15, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Different walk tests with an accelerometer device	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accelerometric variables measured for each walk test		At baseline
Accelerometric variables measured for each walk test		1 hour after baseline

Secondary Outcomes

Measure	Description	Time Frame
Gait speed measured for each walk test		At baseline
Knee flexion and extension strength		At baseline
Gait speed measured for each walk test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

surgery or recent trauma to the lower limbs (under 6 months)
high performance sport
chronic treatment alters the strength in the month before inclusion
pregnant or nursing woman
person under guardianship or curatorship
orthopedic, neuromuscular or neurological disease having an impact on the quality of walking

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut de Myologie - GH Pitié Salpêtrière		Paris	Paris		France