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AmputationNCT06031922

Effectiveness and Cost-effectiveness of Lower Limb Prostheses

An observational study of Amputation and Prosthesis User, run by University Medical Center Groningen at 9 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amputation, Prosthesis User, Prosthesis
Type of treatment
Medical device
How many people
28 participants
Where
9 sitesNetherlands
Study dates
1 Jun 2021to 31 Mar 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Bilateral amputation
  • Osseointegration
  • Previous experience with an MPK

Trial locations and contacts

9 sites in 1 country.

Charlotte E Bosman contact

+31503611348

c.e.bosman@umcg.nl

Aline H Vrieling contact

+31503617743

a.h.vrieling@umcg.nl

9 sites in 1 country

Netherlands9 sites, 9 recruiting
  • Revant medisch specialistische revalidatie

    Breda

    Mirto Xanthouli

    Recruiting
  • Revalidatiecentrum Roessingh

    Enschede

    Behrouz Fard

    Recruiting
  • Revant medisch specialistische revalidatie | Lindenhof

    Goes

    Inge E van Zee

    Recruiting
  • University Medical Center Groningen

    Groningen

    Charlotte E Bosman, +31503611348, c.e.bosman@umcg.nl

    Aline H Vrieling, +31503617743, a.h.vrieling@umcg.nl

    Recruiting
  • Adelante zorggroep

    Hoensbroek

    Anke WE Verlouw

    Recruiting
  • Rijndam Revalidatie

    Rotterdam

    Marieke A Paping

    Recruiting
  • De Hoogstraat Revalidatie

    Utrecht

    Bert Kap

    Recruiting
  • Heliomare Centrum voor Specialistische Revalidatie

    Wijk aan Zee

    Irene Newsum

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

    Zwolle

    Erwin CT Baars

    Recruiting

Other trials in Netherlands

About this study

Official title: Comparing the Effectiveness and Cost-effectiveness of Conventional Mechanical Knees and Microprocessor-controlled Knees: a Prospective Cohort Study

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
Read the 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.
Being tested
Microprocessor controlled knee
Keywords
Effectiveness, transfemoral amputation, knee-disarticulation, Microprocessor controlled knee, prosthetic knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microprocessor controlled kneeDevice

    Microprocessor controlled knee

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)
  1. Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)

    The SQUASH is a questionnaire to measure physical activity [29]. The list is based on the Dutch Standard for Healthy Exercise [30]. This questionnaire contains 11 items to be completed by the participant. The SQUASH measures the frequency, duration and intensity of four different physical activities, namely: physical activity to and from work; household activities; activities at work; and physical activities performed in leisure time. The higher the score, the more time is spent on physical activities.

    Measured: 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.

  2. Timed Up and Go test (TUGtest)

    The Timed Up \& Go test (TUG) measures the time it takes the participant to get up from a chair, walk 3 meters comfortably, turn around, walk back and sit down. Participants are allowed to use their walking aids, but no physical assistance or encouragement should be given.

    Measured: 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.

  3. Activities-Specific Balance Confidence Scale Nederlands (ABC-NL)

    The Activities-Specific Balance Confidence (ABC) Scale is a questionnaire consisting of 16 items. For each item/activity, the patient should indicate how much confidence he/she has in not falling or losing balance when performing them. Each question is scored from 0% to 100% confidence. The activities described take place both indoors and outdoors and are diverse. A high score corresponds to a lot of confidence to perform the activity.

    Measured: 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.

  4. Cost-questionnaire

    To get insight in the costs, two existing questionnaires were combined: the Productivity Cost Questionnaire (iPCQ) and the Medical Consumption Questionnaire (iMCQ).

    The iMCQ is used to measure medical consumption. It includes questions related to the number of appointments with health care providers. The iPCQ measures and values productivity losses. It looks at absenteeism, presenteeism, productivity losses and unpaid work. As this study focussed on costs related to lower limb prostheses, questions about appointments with a dietician and speech therapist, and trips to the emergency room were replaced with questions about the type of prosthesis and the number of appointments with their prosthetist. Finally, questions about personal costs related to the acquisition and repairs of the prosthesis, as well as personal expenses were added.

    Measured: 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.

  5. Prosthesis Evaluation Questionnaire (PEQ)

    The PEQ is a reliable and valid self-report questionnaire to evaluate prosthesis and prosthesis-related quality of life. Questions are divided into nine subscales (ambulation, perceived response, sounds, appearance, residual limb health, utility, frustration, social burden and well-being) and several separate questions related to pain, satisfaction, transfers, prosthetic care, self-efficacy and importance. Most questions are scored on a visual analogue scale (VAS) from 0-100. Some questions about the frequency of certain problems (e.g. pain in residual limb or back) are multiple choice. A higher score on this questionnaire is linked to a more positive outcome.

    Measured: 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.

  6. Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P)

    This questionnaire is used to rate objective and subjective participation. It is composed of 31 items, divided over three scales: 1) frequency: 1a. how much time the participant spends on work, study and household per week, rated on a scale from 0 (not at all) up to 5 (36 hours or more) and 1b. how often the participant partakes in certain activities per week, scored from 0 (not at all) up to 5 (19 times or more); 2) restrictions: whether the participant experiences limitations in daily life and whether they could do certain activities with or without help, scored from 0 (not possible at all) to 3 (independent without difficulty); and 3) satisfaction: how satisfied the participant is with different aspects of daily life, scored on a range from 0 (very dissatisfied) to 4 (very satisfied).

    Measured: 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.

  7. Activity tracking for physical activity (Activ8)

    The Active 8 professional activity monitor was used to register walking during one full week. The activity monitor was placed by the physical therapist on the thigh of the non-affected side of the participant. During the week, the participant was asked to fill out a short diary with the time they got up and went to bed; whether they had worn the monitor for the full 24 hours; whether they had done any physical activity that wasn't in their usual day-to-day routine; and if so during what time that activity was performed.

    Measured: The activity tracker was worn 24 hours a day for 7 days straight.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2023
  2. Study start1 Jun 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06031922
Sponsor's protocol ID
671860
Status last verified
May 2024
First submitted
23 Aug 2023
Last updated
16 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Amputation and Prosthesis User, run by University Medical Center Groningen at 9 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Charlotte E Bosman (+31503611348, c.e.bosman@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 Minute Walking Test (6MWT) (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

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Clinical Trial NCT06031922 | AzTrials