Validation of the Dutch Translation of the Prosthesis Evaluation Questionnaire

Recruiting

• Conditions: Validation Studies

• Registration Number: NCT06493890
• Lead Sponsor: University Medical Center Groningen

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 questionnaires.During the analysis the internal consistency, floor-ceiling effects, test-retest riliability, responsiveness and contruct validity are calculated and determined.

Study Timeline

• Study Start: 2022-11-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-02
• Last Update Submitted: 2024-07-02
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-07-18
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• 18 years or older
• Unilateral lower limb amputation at ankle level or higher
• Mastering Dutch language

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Exclusion Criteria

• Children
• Bilateral or foot amputations

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reliable and validated Dutch version of the PEC	T0: Baseline; T1: two weeks; T2: three months	Cultural adaptation and validation of the Dutch translation of the Prosthesis Evaluation Questionnaire

Trial Locations

Locations (1)

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands