Effectiveness & Cost-effectiveness of Lower Limb Prostheses

Status Recruiting

Clinical Trial 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

Clinical Trial Description

In this prospective cohort study the participants made use of two types of prosthetic knees; the CMK and MKP. A baseline measurement (T0) was performed while the participants were using their own CMK. One week later, they received the MPK to start a six week-trial. During this trial, they received 30 minutes of physical therapy twice a week. In the last week of the trial period, the measurements were performed again (T1). After the trial period, participants switched back to their CMK and after four weeks of getting used to that, the functional performance tests were repeated (T2). Nine months after the last measurement, and if the participant received a MPK, the measurements were repeated again (T3). The measurements consisted of: Physical tests: - 6 minute walking test (6MWT) - Timed up and Go test (TUGtest) Questionnaires: - Cost questionnaire - Activities-Specific Balance Confidence Scale (ABC-NL) - Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P) - Short Questionnaire to Assess Health-enhancing physical activity (SQUASH) - Prosthesis Evaluation Questionnaire (PEQ) Activity monitor: - Activ8 professional. Worn for seven consecutive days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06031922
Study type	Observational
Source	University Medical Center Groningen
Contact	Charlotte E Bosman
Phone	+31503611348
Email	c.e.bosman@umcg.nl
Status	Recruiting
Phase
Start date	June 1, 2021
Completion date	March 31, 2024

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effectiveness and Cost-effectiveness of Lower Limb Prostheses

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms