Actively Recruiting

Age: 18Years +
All Genders
NCT06031922

Effectiveness and Cost-effectiveness of Lower Limb Prostheses

Led by University Medical Center Groningen · Updated on 2024-05-16

28

Participants Needed

9

Research Sites

199 weeks

Total Duration

On this page

Sponsors

U

University Medical Center Groningen

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this observational study is to investigate the effectiveness of NMPKs versus MPKs in persons with an LLA in the standard healthcare system in the Netherlands taking all levels of the ICF model into account. Our main aim is to assess the effect of MPK use compared to NMPK use on walking distance, as this is one of the most used outcome variables in literature and thus enables comparison with previous studies. Our secondary aim is to investigate the effect of NMPKs versus MPKs on all ICF-levels: body structures and function, activities and participation. Participants will be seen four times in a year. During these measurement moments they will: * Perform two physical tests * Fill out a set of questionnaires * Wear an activity tracker for one week

CONDITIONS

Official Title

Effectiveness and Cost-effectiveness of Lower Limb Prostheses

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least one year post amputation
  • Unilateral transfemoral amputation or knee-disarticulation
  • Eligible for a trial on an MPK
  • Able to read and write in Dutch
  • Use a prosthesis with a socket
Not Eligible

You will not qualify if you...

  • Bilateral amputation
  • Osseointegration
  • Previous experience with an MPK

AI-Screening

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Trial Site Locations

Total: 9 locations

1

Revant medisch specialistische revalidatie

Breda, Netherlands

Actively Recruiting

2

Revalidatiecentrum Roessingh

Enschede, Netherlands

Actively Recruiting

3

Revant medisch specialistische revalidatie | Lindenhof

Goes, Netherlands

Actively Recruiting

4

University Medical Center Groningen

Groningen, Netherlands

Actively Recruiting

5

Adelante zorggroep

Hoensbroek, Netherlands

Actively Recruiting

6

Rijndam Revalidatie

Rotterdam, Netherlands

Actively Recruiting

7

De Hoogstraat Revalidatie

Utrecht, Netherlands

Actively Recruiting

8

Heliomare Centrum voor Specialistische Revalidatie

Wijk aan Zee, Netherlands

Actively Recruiting

9

Vogellanden, centrum voor medisch specialistische revalidatie, bijzondere tandheelkunde en gezonde leefstijl

Zwolle, Netherlands

Actively Recruiting

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Research Team

C

Charlotte E Bosman

CONTACT

A

Aline H Vrieling

CONTACT

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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