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NCT Number: NCT06493890

Validation of the Dutch Translation of the Prosthesis Evaluation Questionnaire

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Validation PEQ-DLV

Other

Validation of the Dutch Language version of the Prosthesis Evaluation Questionnaire

Primary outcomes

  1. Reliable and validated Dutch version of the PEC

    Time frame: T0: Baseline; T1: two weeks; T2: three months

    Cultural adaptation and validation of the Dutch translation of the Prosthesis Evaluation Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte E Bosman

CONTACT

[email protected]

+31503611348

Maaike A Hulshof, Drs

CONTACT

[email protected]

+31 655257510

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Stichting Beatrixoord Noord-Nederland

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 10, 2024
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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