Validation of the Dutch Translation of the Prosthesis Evaluation Questionnaire

NCT06493890 | Recruiting

• 1 other identifier: MH28062024
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Validation Studies

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Validation PEQ-DLV OTHER

Validation of the Dutch Language version of the Prosthesis Evaluation Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Children
• Bilateral or foot amputations

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Stichting Beatrixoord Noord-Nederland: collaborator

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

RECRUITING

Study Officials

• Corry K Sluis, Prof

  University Medical Center Groningen

  STUDY CHAIR

Central Study Contacts

Maaike A Hulshof, Drs

CONTACT

+31 655257510; m.a.hulshof@umcg.nl

Charlotte E Bosman

CONTACT

+31503611348; c.e.bosman@umcg.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: November 1, 2022
• Primary Completion: July 18, 2024
• Study Completion: December 31, 2025
• Last Updated: April 1, 2025

Record last verified: 2024-12

Locations

NL (1)