Clinical trial NCT06493890: Validation of the Dutch Translation of the Prosthesis Evaluation Questionnaire
Official title: Cultural Adaptation and Validation of the Prosthesis Evaluation Questionnaire - Dutch Language Version in Lower Limb Prosthesis Users
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Validation Studies
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Stichting Beatrixoord Noord-Nederland
First posted: 2024-07-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reliable and validated Dutch version of the PEC
timeFrame: T0: Baseline; T1: two weeks; T2: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Corry K Sluis, Prof
role: STUDY_CHAIR
References: