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.
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.
9 sites in 1 country
Netherlands9 sites, 9 recruiting
- 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
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.
- Conditions
- Amputation, Prosthesis User, Prosthesis
- 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.
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)
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.
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.
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.
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.
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.
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.
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.
- First posted11 Sep 2023
- Study start1 Jun 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness and Cost-effectiveness of Conventional Mechanical Knees and Microprocessor-controlled Knees: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06031922
- Acronym / sponsor ID
- 671860
- Conditions
- Amputation, Prosthesis User, Prosthesis
- Keywords
- Effectiveness, transfemoral amputation, knee-disarticulation, Microprocessor controlled knee, prosthetic knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Bilateral amputation
- Osseointegration
- Previous experience with an MPK
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microprocessor controlled kneeMicroprocessor controlled knee | Device | – |
Primary outcome
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)
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.
7 secondary outcomes
Short Questionnaire to Assess Health-enhancing physical activity (SQUASH)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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.
Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P)
Time frame: 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.
Activity tracking for physical activity (Activ8)
Time frame: The activity tracker was worn 24 hours a day for 7 days straight.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
9 sites in 1 country: see every site and its status.
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.