Actively Recruiting
Cultural Adaptation and Validation of the Prosthesis Evaluation Questionnaire - Dutch Language Version in Lower Limb Prosthesis Users
Led by University Medical Center Groningen · Updated on 2025-04-01
84
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
S
Stichting Beatrixoord Noord-Nederland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a study to translate and validate the Prosthesis Evaluation Questionnaire (PEQ) for Dutch-speaking adults who use a lower limb prosthesis. The PEQ is a reliable tool used to assess quality of life in this population. The research is divided into two phases: first translating the questionnaire, then validating it among prosthesis users with unilateral amputations at or above the ankle. The first phase involved translating and back-translating the PEQ according to established guidelines, followed by testing with 30 patients to refine the Dutch version (PEQ-DLV). In the second phase, 84 participants will complete a general survey, the PEQ-DLV, and the RAND-36 questionnaire at baseline. They will retake the PEQ-DLV two weeks and three months later to assess its reliability and validity. Participants will complete questionnaires digitally at three different times over three months. Researchers will analyze responses to measure consistency, reliability, responsiveness, and validity of the Dutch PEQ. Participants who complete all questionnaires will receive a 20 euro compensation. The study is led by the University Medical Center Groningen and aims to provide a valid Dutch tool to assess quality of life in lower limb prosthesis users.
CONDITIONS
Brief Title
Validation of the Dutch Translation of the Prosthesis Evaluation Questionnaire
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Unilateral lower limb amputation at ankle level or higher
- Mastering Dutch language
You will not qualify if you...
- Children
- Bilateral or foot amputations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (digital consent and initial questionnaires)
Duration - 3 months
Participants complete the Dutch language version of the Prosthesis Evaluation Questionnaire (PEQ-DLV) and related surveys for validation purposes.
3 digital questionnaire sessions at baseline, 2 weeks, and 3 months
Trial Site Locations
Total: 1 location
1
University Medical Centre Groningen
Groningen, Provincie Groningen, Netherlands, 9713GZ
Actively Recruiting
Research Team
M
Maaike A Hulshof, Drs
C
Charlotte E Bosman
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here