Effectiveness and Cost-effectiveness of Lower Limb Prostheses

NCT06031922 | Recruiting

• 1 other identifier: 671860
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

Effectiveness; transfemoral amputation; knee-disarticulation; Microprocessor controlled knee; prosthetic knee

Outcome Measures

Primary Outcomes (1)

• 6 Minute Walking Test (6MWT)

  The 6-minute walk test is used to measure functional capacity. The maximum distance a participant can walk within 6 minutes is measured. The course can be 10, 30 or 50 meters. The participant can use their walking aid if needed.

  This test takes 6 minutes and is performed at T0 (week 1 after inclusion), T1 (week 7 after inclusion), T2 (week 12 after inclusion) and T3 (week 52 after inclusion)

Secondary Outcomes (7)

• Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)

  Participants were asked to fill out the questionnaire at T0 (week 1 after inclusion), T1 (week 7 after inclusion) and T3 (week 52 after inclusion), with a normal/standard week for them in mind.

• Timed Up and Go test (TUGtest)

  This test is performed at T0 (week 1 after inclusion), T1 (week 7 after inclusion), T2 (week 12 after inclusion) and T3 (week 52 after inclusion). It can take up to three minutes.

• Activities-Specific Balance Confidence Scale Nederlands (ABC-NL)

  Participants were asked to fill out the questionnaire at T0 (week 1 after inclusion), T1 (week 7 after inclusion) and T3 (week 52 after inclusion), based on their current situation that day.

• Cost-questionnaire

  At T0 (week 1 after inclusion) and T3 (week 52 after inclusion), participants were asked to fill out the questionnaire over a retrospective period of six months.

• Prosthesis Evaluation Questionnaire (PEQ)

  Participants were asked to fill out the questionnaire at T0 (week 1 after inclusion), T1 (week 7 after inclusion) and T3 (week 52 after inclusion) over a retrospective period of four weeks.

Interventions

Microprocessor controlled knee DEVICE

Microprocessor controlled knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We included adult participants with a unilateral transfemoral amputation or knee-disarticulation who were using a prosthesis with a CMK, but were eligible for a trial on an MPK.

You may qualify if:

• 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

You may not qualify if:

• Bilateral amputation
• Osseointegration
• Previous experience with an MPK

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (9)

Revant medisch specialistische revalidatie

Breda, Netherlands

RECRUITING

Revalidatiecentrum Roessingh

Enschede, Netherlands

RECRUITING

Revant medisch specialistische revalidatie | Lindenhof

Goes, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

Adelante zorggroep

Hoensbroek, Netherlands

RECRUITING

Rijndam Revalidatie

Rotterdam, Netherlands

RECRUITING

De Hoogstraat Revalidatie

Utrecht, Netherlands

RECRUITING

Heliomare Centrum voor Specialistische Revalidatie

Wijk aan Zee, Netherlands

RECRUITING

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

Zwolle, Netherlands

RECRUITING

Central Study Contacts

Charlotte E Bosman

CONTACT

+31503611348; c.e.bosman@umcg.nl

Aline H Vrieling

CONTACT

+31503617743; a.h.vrieling@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 11, 2023
• Study Start: June 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

NL (9)