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Effectiveness and Cost-effectiveness of Lower Limb Prostheses

NCT ID: NCT06031922

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Amputation Prosthesis User Prosthesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Microprocessor controlled knee

Microprocessor controlled knee

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Bilateral amputation
* Osseointegration
* Previous experience with an MPK
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Revant medisch specialistische revalidatie

Breda, , Netherlands

Site Status RECRUITING

Revalidatiecentrum Roessingh

Enschede, , Netherlands

Site Status RECRUITING

Revant medisch specialistische revalidatie | Lindenhof

Goes, , Netherlands

Site Status RECRUITING

University Medical Center Groningen

Groningen, , Netherlands

Site Status RECRUITING

Adelante zorggroep

Hoensbroek, , Netherlands

Site Status RECRUITING

Rijndam Revalidatie

Rotterdam, , Netherlands

Site Status RECRUITING

De Hoogstraat Revalidatie

Utrecht, , Netherlands

Site Status RECRUITING

Heliomare Centrum voor Specialistische Revalidatie

Wijk aan Zee, , Netherlands

Site Status RECRUITING

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

Zwolle, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Charlotte E Bosman

Role: CONTACT

[email protected]
+31503611348

Aline H Vrieling

Role: CONTACT

[email protected]
+31503617743

Facility Contacts

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Mirto Xanthouli

Role: primary

Behrouz Fard

Role: primary

Inge E van Zee

Role: primary

Charlotte E Bosman

Role: primary

[email protected]
+31503611348

Aline H Vrieling

Role: backup

[email protected]
+31503617743

Anke WE Verlouw

Role: primary

Marieke A Paping

Role: primary

Bert Kap

Role: primary

Irene Newsum

Role: primary

Erwin CT Baars

Role: primary

Other Identifiers

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671860

Identifier Type: -

Identifier Source: org_study_id

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