Evaluation of Self-reported Walking Impairment in Predomi... | NCT03482869

Studies
Evaluation of Self-reported Walking Impairment in Predominantly Illiterate Patients

NCT03482869

Sponsor

Université Polytechnique de Bobo-Dioulasso

Status

Unknown status

Last Update Posted

Mar 29, 2018Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Diabetes

Interventions

walking ability

Countries

Burkina Faso

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

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 30, 2018Estimated

Primary Completion Date

Aug 30, 2018Estimated

Completion Date

Aug 30, 2018Estimated

First Submitted Date

Mar 14, 2018

First Submission Date that Met QC Criteria

Mar 28, 2018

First Posted Date

Mar 29, 2018Actual

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

Mar 28, 2018

Last Update Posted Date

Mar 29, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nafi OUEDRAOGO, Head of department of physiology, Université Polytechnique de Bobo-DioulassoPrincipal Investigator

Lead Sponsor

Université Polytechnique de Bobo-DioulassoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 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.

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

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

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetic patients	Experimental	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	Diagnostic Test: walking ability

Interventions

Name	Type	Description	Arm Group Labels	Other Names
walking ability	Diagnostic Test	Included patients will perform a 6 min walk test	Diabetic patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximal walking distance	Maximal measured distance will be the distance walked during a 6 min walk tests	10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

•Signed consent for the data treatment as a database

Exclusion Criteria:

Rebuttal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nafi OUEDRAOGO, MD	Contact	+22670155806		Nafioued@yahoo.fr

Overall Officials

Name	Affiliation	Role
Nafi OUEDRAOGO	CHU Souro Sanou	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Souro Sanou		Bobo-Dioulasso			Burkina Faso

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Probably available upon request. Undecided yet

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided