Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493890
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Validation of the Dutch Translation of the Prosthesis Evaluation Questionnaire
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Cultural Adaptation and Validation of the Prosthesis Evaluation Questionnaire - Dutch Language Version in Lower Limb Prosthesis Users
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of our research is to be able to use the questionnaire Prosthesis Evaluation Questionnaire PEQ in Dutch The PEQ is a validated and reliable questionnaire for research into the quality of life in adults with a lower limb prosthesis The research consists of two phases The first phase is the translation of the PEQ and the second phase is the validation of this questionnaire To validate the questionnaire we want to include 84 participants who have to complete questionnaires three times within a period of three months
Detailed Description:
The study consists of two phases The first phase is the translation of the Prosthesis Evaluation Questionnaire PEQ and the second phase is the validation of this questionnaire
Phase 1 translation PEQ The Beaton guidelines were followed for the translation of the questionnaire After translation and back-translation version A of the translated PEQ was created This version was tested on 30 adult patients with a lower leg prosthesis Based on the feedback from the patients the Dutch language version of the PEQ was created PEQ-DLV
Phase 2 validation PEQ-DLV For the process of validation three questionnaires were used a general survey the PEQ-DLV and the RAND-36 The participants were approached via a large orthopedic workshop and the national patient association KorterMaarKrachtig KMK The aim was to include 84 lower limb prosthesis users with an unilateral amputation at ankle level or higher At baseline T0 patients received a digital consent form the general survey the PEQ-DLV and the RAND-36 Two weeks T1 and three months T2 after baseline the participants who completed all questionnaires received the PEQ-DLV again For motivation and as a token of appreciation participants received a compensation of 20 euros after filling in all questionnairesDuring the analysis the internal consistency floor-ceiling effects test-retest riliability responsiveness and contruct validity are calculated and determined
Phase 1 translation PEQ The Beaton guidelines were followed for the translation of the questionnaire After translation and back-translation version A of the translated PEQ was created This version was tested on 30 adult patients with a lower leg prosthesis Based on the feedback from the patients the Dutch language version of the PEQ was created PEQ-DLV
Phase 2 validation PEQ-DLV For the process of validation three questionnaires were used a general survey the PEQ-DLV and the RAND-36 The participants were approached via a large orthopedic workshop and the national patient association KorterMaarKrachtig KMK The aim was to include 84 lower limb prosthesis users with an unilateral amputation at ankle level or higher At baseline T0 patients received a digital consent form the general survey the PEQ-DLV and the RAND-36 Two weeks T1 and three months T2 after baseline the participants who completed all questionnaires received the PEQ-DLV again For motivation and as a token of appreciation participants received a compensation of 20 euros after filling in all questionnairesDuring the analysis the internal consistency floor-ceiling effects test-retest riliability responsiveness and contruct validity are calculated and determined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None