Amputation Clinical Trial
Official title:
Comparing the Effectiveness and Cost-effectiveness of Conventional Mechanical Knees and Microprocessor-controlled Knees: a Prospective Cohort Study
NCT number | NCT06031922 |
Other study ID # | 671860 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2021 |
Est. completion date | March 31, 2025 |
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
Status | Recruiting |
Enrollment | 28 |
Est. completion date | March 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Revant medisch specialistische revalidatie | Breda | |
Netherlands | Revalidatiecentrum Roessingh | Enschede | |
Netherlands | Revant medisch specialistische revalidatie | Lindenhof | Goes | |
Netherlands | University Medical Center Groningen | Groningen | |
Netherlands | Adelante zorggroep | Hoensbroek | |
Netherlands | Rijndam Revalidatie | Rotterdam | |
Netherlands | De Hoogstraat Revalidatie | Utrecht | |
Netherlands | Heliomare Centrum voor Specialistische Revalidatie | Wijk Aan Zee | |
Netherlands | Vogellanden, centrum voor medisch specialistische revalidatie, bijzondere tandheelkunde en gezonde leefstijl | Zwolle |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 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. | |
Secondary | 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. | 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. | |
Secondary | 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. | 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. | |
Secondary | 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. |
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. | |
Secondary | 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. | 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. | |
Secondary | 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). | 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. | |
Secondary | 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. | The activity tracker was worn 24 hours a day for 7 days straight. |
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