Clinical trial NCT06031922: Effectiveness and Cost-effectiveness of Lower Limb Prostheses
Official title: Comparing the Effectiveness and Cost-effectiveness of Conventional Mechanical Knees and Microprocessor-controlled Knees: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amputation
Prosthesis User
Prosthesis
Keywords: Effectiveness
transfemoral amputation
knee-disarticulation
Microprocessor controlled knee
prosthetic knee
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-09-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 6 Minute Walking Test (6MWT)
timeFrame: 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:
measure: Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)
timeFrame: 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.
measure: Timed Up and Go test (TUGtest)
timeFrame: 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.
measure: Activities-Specific Balance Confidence Scale Nederlands (ABC-NL)
timeFrame: 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.
measure: Cost-questionnaire
timeFrame: 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.
measure: Prosthesis Evaluation Questionnaire (PEQ)
timeFrame: 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.
measure: Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P)
timeFrame: 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.
measure: Activity tracking for physical activity (Activ8)
timeFrame: The activity tracker was worn 24 hours a day for 7 days straight.
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Revant medisch specialistische revalidatie
city: Enschede
country: Netherlands
facility: Revalidatiecentrum Roessingh
city: Goes
country: Netherlands
facility: Revant medisch specialistische revalidatie | Lindenhof
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Hoensbroek
country: Netherlands
facility: Adelante zorggroep
city: Rotterdam
country: Netherlands
facility: Rijndam Revalidatie
city: Utrecht
country: Netherlands
facility: De Hoogstraat Revalidatie
city: Wijk Aan Zee
country: Netherlands
facility: Heliomare Centrum voor Specialistische Revalidatie
city: Zwolle
country: Netherlands
facility: Vogellanden, centrum voor medisch specialistische revalidatie, bijzondere tandheelkunde en gezonde leefstijl
Study officials:
References: