Validation StudiesNCT06493890
Validation of the Dutch Translation of the Prosthesis Evaluation Questionnaire
An observational study of Validation Studies, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Validation Studies
- What is being tested?
- Validation PEQ-DLV
- How many people
- 84 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years or older
- Unilateral lower limb amputation at ankle level or higher
- Mastering Dutch language
Who cannot join
- Children
- Bilateral or foot amputations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Centre Groningen
Groningen, Provincie Groningen, 9713GZ
Maaike A Hulshof, +31 655257510, m.a.hulshof@umcg.nl
Charlotte E Bosman, +31503611348, c.e.bosman@umcg.nl
About this study
Official title: Cultural Adaptation and Validation of the Prosthesis Evaluation Questionnaire - Dutch Language Version in Lower Limb Prosthesis Users
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.
Read the 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.
- Conditions
- Validation Studies
- Being tested
- Validation PEQ-DLV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation PEQ-DLVOther
Validation of the Dutch Language version of the Prosthesis Evaluation Questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliable and validated Dutch version of the PEC
Cultural adaptation and validation of the Dutch translation of the Prosthesis Evaluation Questionnaire
Measured: T0: Baseline; T1: two weeks; T2: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Nov 2022
- Primary completion18 Jul 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation StudiesStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Beatrixoord Noord-Nederland
- Responsible party
- Sponsor
- Investigators
- Corry K Sluis, Prof, Study chair, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493890
- Sponsor's protocol ID
- MH28062024
- Status last verified
- Dec 2024
- First submitted
- 2 Jul 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation and Validation of the Prosthesis Evaluation Questionnaire - Dutch Language Version in Lower Limb Prosthesis Users
- ClinicalTrials.gov ID
- NCT06493890
- Acronym / sponsor ID
- MH28062024
- Conditions
- Validation Studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Stichting Beatrixoord Noord-Nederland
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18 years or older
- Unilateral lower limb amputation at ankle level or higher
- Mastering Dutch language
Key exclusion criteria (2 listed)
- Children
- Bilateral or foot amputations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation PEQ-DLVValidation of the Dutch Language version of the Prosthesis Evaluation Questionnaire | Other | – |
Primary outcome
Reliable and validated Dutch version of the PEC
Time frame: T0: Baseline; T1: two weeks; T2: three months
Cultural adaptation and validation of the Dutch translation of the Prosthesis Evaluation Questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Corry K Sluis, Prof study chair
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation Studies, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maaike A Hulshof, Drs (+31 655257510, m.a.hulshof@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliable and validated Dutch version of the PEC (time frame: T0: Baseline; T1: two weeks; T2: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.