No registrations found.
ID
Source
Brief title
Health condition
Upper limb defects, including both amputations and congenital deficits.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cost-utility calculated with the Multi-Attribute Preference Response (MAPR) and total costs from a societal perspective, shown as an incemental cost-effectiveness ratio
Secondary outcome
- Box & Block test
- Southampton Hand Assessment Procedure (SHAP)
- Movement analyses focussed on compensation
- Dutch user Quebec evaluation score (D-QUEST)
- Trinity Amputation and Prosthesis Experience Scales (TAPES)
- Orthotics and prosthetics user survey (OPUS)
- Quality of life (RABD-36 & EQ-5D)
- MAPR-score
- Average costs from the SMP and MMP from a societal perspective
Background summary
Last decade costs of health care related to upper limb prosthesis in the Netherlands are raising. The introduction of innovative types of prostheses, like the multi-articulated myoelectric prosthesis (MMP) with moveable thumb and fingers, seems to be one of the causes for this raise. MMPs have functional advantages, but also have disadvantages: less durable, difficult to control, and more expensive. Probably, for some persons, a more simple prosthesis would meet their expectations as well. Current literature about the cost-efficiency of upper limb prosthesis is limited. Therefore the aim of this study was to compare the efficacy, cost-efficiency, and cost-utility of the 'standard' myoelectric upper limb prosthesis (SMP) with the MMP. We will perform a cross-sectional study with a limited cross-over design, which exists of two phases. In the first phase, MMP users are performing several tests with the MMP and SMP to compare the efficacy of these prostheses. In the second phase, persons with an MMP and persons with an SMP are asked to complete surveys about the costs of their prosthesis and all costs related to the prosthesis, quality of life, users' value of the prosthesis, and satisfaction with the prosthesis.
Study objective
We hypothesize that the MMP could be cost-efficient for a part of the patients, but that for some patients a more simple prosthesis would be more cost-efficient. Therefore, we do not expect big differences in cost-effectiveness between the MMP and SMP.
Study design
Sep 2020: Start inclusion
Okt - Dec 2020: Measurements
Jan - Mar 2021: File investigation
Intervention
NA
Inclusion criteria
Inclusion criteria phase 1 & 2- MMP group:
- Age 18 years or older
- At least one year experience with an MMP, type be-bionic, I-limb or VINCENT
- Owner of an MMP, type be-bionic, I-limb or VINCENT
- The person is in a stable phase of the prosthesis provision process
- Sufficient command of the Dutch language to follow instructions and complete questionnaires
Inclusion criteria phase 2 - SMP group:
- Age 18 years or older
- At least one year experience with an SMP with one grip mode
- Owner of an SHP with one grip mode
- The person is in a stable phase of the prosthesis provision process
- Sufficient command of the Dutch language to follow instructions and complete questionnaires
Exclusion criteria
Exclusion criteria phase 1 & 2- MMP group:
- Co-morbidities that could influence the results of this study, like neurological disorders, rheumatic diseases, and other disorders that could affect the arm function
- Owner of an MMP, type Michelangelo
Exclusion criteria phase 2 - SMP group:
- Co-morbidities that could influence the results of this study, like neurological disorders, rheumatic diseases, and other disorders that could affect the arm function
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8730 |
| Other | Medical Ethics Review Board of the University Medical Center Groningen (UMCG) : METc2018/582 |