No registrations found.
ID
Source
Brief title
Health condition
limb amputation
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prosthesis Evaluation Questionnaire, Utrechtse Schaal voor Evaluatie van Revalidatie-Participatie (USER-P), activity monitor
Secondary outcome
Short Questionnaire to assess health-enhancing physical activity (SQUASH), 6 Minutes Walking Test (6MWT), Timed Get Up en Go Test (TGUGT), Activities-Specific Balance Confidence Scale (ABC)
Background summary
A correct choice of the components of the prosthesis is of great importance for the best possible outcome of the rehabilitation process. An important innovation for patients with a lower limb amputation through or above the knee is the development of auto-adaptive knee units (AAKs). The total annual costs per user of a leg prosthesis have increased by 37% over the last 5 years: from € 3,110 in 2012 to € 4,260 in 2016. Whether this increase in costs is related to more frequent prescribing of (a more expensive) AAK, and whether this cost increase also leads to an increase in effectiveness, has not been investigated so far. In this study we compare the effectiveness and cost-effectiveness of an AAK with that of a conventional mechanical prosthetic knee (CMK). In addition, we determine the (cost)effectiveness of integrated care with regard to lower limb prostheses by examining the extent of appropriate use of the lower limb prosthesis in relation to the costs of integrated care. Appropriate use is the effective use of the most adequate lower limb prosthesis, tailored to the real needs of the user. To implement the knowledge in clinical practice, we develop an online decision aid for users of lower limb prostheses and a national database for caregivers in order to optimally meet the needs and possibilities of the user to match the characteristics of the prosthesis.
Study objective
Appropriate use and prescription of a lower limb prosthesis for people with leg amputation through or above the knee, can increase the efficiency of the integrated care around the leg prosthesis.
Study design
Baseline, 3 AAK en 3 CMK measure points
Intervention
autoadaptive prosthetic knee
Inclusion criteria
- age> 18 years
- unilateral transfemoral amputation or knee articulation> 1 year ago
- prosthetic device with CMK in a stable phase
- Medicare Functional Classification K level 2-4 (i.e. the participant is at least able to walk outside with or without
walking aid over uneven ground and can climb stairs)
- sufficient understanding of the Dutch language to be able to follow instructions and to complete questionnaires
- one of the two indications for AAK as described in detail in the AAK addendum to the PPP protocol: 1. need for extra security and stability, 2. high dynamic use
Exclusion criteria
not applicable
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7887 |
| Other | METC UMCG : in progress |