- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03097263
Is the Walking Velocity an Efficient Outcome of Rehabilitation Program in Non- Specific Low Back Pain Patient (MARLO)
March 27, 2017 updated by: Centre Hospitalier Universitaire Dijon
Despite the prevalence of chronic low back pain, functional symptomatology of this disease remains poor and treatment decisions are based mainly on subjective data (importance and pain tolerance).
However, there are some experimental elements that involve objective assessment of locomotor capabilities - at forefront objectives which the walking velocity in the evaluation of this pathology in terms of severity of functional impairment.
Recent evidence suggest the effectiveness of physical rehabilitation program for improving patients functional capacities and their reintegration in socio-professional life.
This retrospective study aims to quantify the evolution of the parameters collected during standardized walking tests performed before and after rehabilitation program.
These patients have systematically carry out a comfortable walk test (400m walk test) and a brisk walk test (200m) at the beginning and end of their program.
Furthermore, a maximal stress test on a treadmill was performed before the program in order to detect any cardiovascular events and to allow the personalization of the effort level required (target heart rate) during rehabilitation.
In this study the evolution of the comfortable and fast speed will be collected and compared with the stress test data, and other measured parameters (functional score of Quebec, muscle Tests Shirado and Sorensen).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
127
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
-
-
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Dijon, France, 21079
- Rehabiltiation department CHU Dijon
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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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Non-specific low back pain patients included for rehabilitation program
Description
Inclusion Criteria:
- Female or male
- age between 18 and 70
- Non-specific low back pain - achieved rehabilitation program
Exclusion Criteria:
- inflammatory diseases
- cancer
- infectious diseases
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
Patients included for rehabilitation program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
COMFORTABLE WALKING SPEED (TEST OF 400M)
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
200m fast walk test walking velocity
Time Frame: 4 weeks
|
4 weeks
|
Quebec score
Time Frame: 4 weeks
|
4 weeks
|
Shirado test
Time Frame: 4 weeks
|
4 weeks
|
Sorensen test
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
January 1, 2014
Primary Completion (Actual)
October 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
November 3, 2016
First Submitted That Met QC Criteria
March 27, 2017
First Posted (Actual)
March 31, 2017
Study Record Updates
Last Update Posted (Actual)
March 31, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASILLAS Marlo 2016
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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