- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03482869
Evaluation of Self-reported Walking Impairment in Predominantly Illiterate Patients (WELSH)
March 28, 2018 updated by: Nafi OUEDRAOGO, Université Polytechnique de Bobo-Dioulasso
The Walking Estimated Limitation Stated by History (WELSH): A Visual Tool to Self-report Walking Impairment From a Predominantly Illiterate Diabetic Population.
The purpose of this study is to test the routine feasibility of an image tool adapted from the WELCH questionnaire ( Walking estimated limitation calculated by history) to estimate walking impairment (The WELSH questionnaire: Walking estimated limitation stated by history) in patients investigated for walking impairment.
Secondary aims correlation with the maximal walking distance.
Study Overview
Detailed Description
The WELSH is self completed by the patients and scored by the physician after self-completion.
Patients perform a 6 minutes walking test on a 30m corridor
Study Type
Interventional
Enrollment (Anticipated)
150
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 Contact
- Name: Nafi OUEDRAOGO, MD
- Phone Number: +22670155806
- Email: Nafioued@yahoo.fr
Study Locations
-
-
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Bobo Dioulasso, Burkina Faso
- CHU Souro Sanou
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Contact:
- Nafi OUEDRAOGO
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- •Signed consent for the data treatment as a database
Exclusion Criteria:
- Rebuttal to participate
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diabetic patients
Patients referred for the equilibrium or diagnosis of diabetes mellitus will be proposed to participate and estimate their walking ability with the WELSH (Walking estimated limitation stated by History) based solely on images
|
Included patients will perform a 6 min walk test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal walking distance
Time Frame: 10 minutes
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Maximal measured distance will be the distance walked during a 6 min walk tests
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nafi OUEDRAOGO, CHU Souro Sanou
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 (Anticipated)
March 30, 2018
Primary Completion (Anticipated)
August 30, 2018
Study Completion (Anticipated)
August 30, 2018
Study Registration Dates
First Submitted
March 14, 2018
First Submitted That Met QC Criteria
March 28, 2018
First Posted (Actual)
March 29, 2018
Study Record Updates
Last Update Posted (Actual)
March 29, 2018
Last Update Submitted That Met QC Criteria
March 28, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Bobo 2018-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Probably available upon request.
Undecided yet
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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