NCT03482869

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

March 30, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

March 14, 2018

Last Update Submit

March 28, 2018

Conditions

Keywords

walking impairmentdisabilitydiabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Maximal walking distance

    Maximal measured distance will be the distance walked during a 6 min walk tests

    10 minutes

Study Arms (1)

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

walking abilityDIAGNOSTIC_TEST

Included patients will perform a 6 min walk test

Diabetic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed consent for the data treatment as a database

You may not qualify if:

  • Rebuttal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Souro Sanou

Bobo-Dioulasso, Burkina Faso

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nafi OUEDRAOGO

    CHU Souro Sanou

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nafi OUEDRAOGO, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective cohort
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department of physiology

Study Record Dates

First Submitted

March 14, 2018

First Posted

March 29, 2018

Study Start

March 30, 2018

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations