Actively Recruiting

Age: 18Years +
All Genders
ID06493890

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Unilateral lower limb amputation at ankle level or higher
  • Mastering Dutch language
Not Eligible

You will not qualify if you...

  • Children
  • Bilateral or foot amputations

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (digital consent and initial questionnaires)

Validation

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

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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

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