Validation of the Dutch Translation of the Prosthesis Evaluation Questionnaire

Cultural Adaptation and Validation of the Prosthesis Evaluation Questionnaire - Dutch Language Version in Lower Limb Prosthesis Users

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.

Study Overview

• Status: Recruiting
• Conditions: Validation Studies
• Intervention / Treatment: Other: Validation PEQ-DLV

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 Type: Observational
• Enrollment (Estimated): 84

Contacts and Locations

• Study Contact: Name: Charlotte E Bosman; Phone Number: +31503611348; Email: c.e.bosman@umcg.nl
• Study Contact Backup: Name: Maaike A Hulshof, Drs; Phone Number: +31 655257510; Email: m.a.hulshof@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • Recruiting
    • University Medical Centre Groningen
    • Contact: Charlotte E Bosman; Phone Number: +31503611348; Email: c.e.bosman@umcg.nl
    • Contact: Maaike A Hulshof; Phone Number: +31 655257510; Email: m.a.hulshof@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The participants were approached via a large orthopedic workshop (with several locations nationwide) by mail and via the national patient association KorterMaarKrachtig (KMK) through a request on the KMK-website, Twitter, LinkedIn and Facebook-page. An information letter was provided and adult lower limb prosthesis users were able to sign up by providing their email address via a registration link. The inclusion criteria are as mentioned above. The aim was to include 84 participants. For motivation and as a token of appreciation, participants received a compensation of 20 euros.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Children
• Bilateral or foot amputations

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Stichting Beatrixoord Noord-Nederland
• Investigators: Study Chair: Corry K Sluis, Prof, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): July 18, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MH28062024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No