- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01522690
Assessment of Accelerometric Measurement Devices for Gait Analysis (ACCELERIX)
April 14, 2016 updated by: Institut de Myologie, France
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France
- Institut de Myologie - GH Pitié Salpêtrière
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 85 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Accelerometric variables measured for each walk test
Time Frame: At baseline
|
At baseline
|
|
Accelerometric variables measured for each walk test
Time Frame: 1 hour after baseline
|
1 hour after baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gait speed measured for each walk test
Time Frame: At baseline
|
At baseline
|
|
Knee flexion and extension strength
Time Frame: At baseline
|
At baseline
|
|
Gait speed measured for each walk test
Time Frame: 1 hour after baseline
|
1 hour after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
January 4, 2012
First Submitted That Met QC Criteria
January 27, 2012
First Posted (Estimate)
February 1, 2012
Study Record Updates
Last Update Posted (Estimate)
April 15, 2016
Last Update Submitted That Met QC Criteria
April 14, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ACCELERIX
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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