Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06493890
Enrollment
84
Registered
2024-07-10
Start date
2022-11-01
Completion date
2025-12-31
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Validation Studies

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.

Interventions

OTHERValidation PEQ-DLV

Validation of the Dutch Language version of the Prosthesis Evaluation Questionnaire

Sponsors

Stichting Beatrixoord Noord-Nederland
CollaboratorUNKNOWN
University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Reliable and validated Dutch version of the PECT0: Baseline; T1: two weeks; T2: three monthsCultural adaptation and validation of the Dutch translation of the Prosthesis Evaluation Questionnaire

Countries

Netherlands

Contacts

Primary ContactMaaike A Hulshof, Drs
m.a.hulshof@umcg.nl+31 655257510
Backup ContactCharlotte E Bosman
c.e.bosman@umcg.nl+31503611348

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026