Skip to main content
Clinical Trials/NCT01424020
NCT01424020
Unknown
Phase 4

Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Les Patients adressés Pour Bilan artériel Des Membres inférieurs

University Hospital, Angers3 sites in 1 country800 target enrollmentSeptember 2011

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Peripheral Artery Disease
Sponsor
University Hospital, Angers
Enrollment
800
Locations
3
Primary Endpoint
Proportion of questionnaires with errors after self completion
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to test and validate a new questionnaire in order to get a "walking estimated limitation calculated by history (WELCH) in patients referred for vascular investigations.

Detailed Description

Two questionnaires the WELCH and the "walking impairment questionnaire" (WIQ) are submitted to patients referred for vascular investigations for suspêcted peripheral arterial disease (PAD). Comparison of score to hemodynamic parameters (first goal) or maximal walking distance (MWD) on treadmill (secondary goal). Scoring of the WIQ is performed according to references. Scoring of the WELCH has been submitted for copyright protection (involves a series of 4 additions a subtraction and a single multiplication)

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
November 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Angers
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • French Native language
  • 18 years old or older
  • Signed consent
  • Covered by the French social care system

Exclusion Criteria

  • Unable to participate for administrative reasons
  • Psychiatric troubles
  • Pain at rest or critical limb ischemia
  • Unable to walk (ex: wheelchair subjects)
  • Note: previous inclusion in the protocole is note an exclusion criterion for a new participation.

Outcomes

Primary Outcomes

Proportion of questionnaires with errors after self completion

Time Frame: 1 day

Analysis of first inclusion only in patients that are included multiple times over the study period. Predetermined score for the WELCH questionnaire answers \[(4 items); (4 additions \& 1 multiplication)\] and WIQ... estimation of the percentage of errors with 95% confidence interval. Comparison of the two percentages

Secondary Outcomes

  • Correlation with treadmill result(1 day)
  • Facility of the scoring of the questionnaires(1 day)
  • Reliability of the questionnaire(3 weeks)
  • sensitivity of the WELCH to changes(1 year)
  • Correlation with ankle brachial index (ABI)(1 day)

Study Sites (3)

Loading locations...

Similar Trials