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Effectiveness and Cost-effectiveness of Lower Limb Prostheses

NCT06031922 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2024-05-16

No results posted yet for this study

Summary

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

  • Amputation
  • Prosthesis User
  • Prosthesis

Interventions

DEVICE

Microprocessor controlled knee

Microprocessor controlled knee

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-12-31
Completion
2025-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06031922 on ClinicalTrials.gov