Amputation
Conditions
Keywords
transfemoral amputation, prosthetic user, microprocessor-controlled knee, functional outcomes, patient-reported outcomes
Brief summary
This study investigates prosthetic users´ report of passive microprocessor-controlled knees (pMPK) vs. active microprocessor-controlled knees (aMPK). Outcome measurements are assessed at baseline with the pMPK and after 4 weeks of continuous use of aMPK. Measurements consists of functional outcomes, as well as patient-reported outcomes.
Detailed description
The Intuy Knee, an active electronic microprocessor-controlled prosthesis, aims to improve symmetry in joints, torque, and muscle activation compared to passive prostheses. Furthermore, it provides benefits of active prostheses in terms of weight distribution, stair climbing ease, and reduced oxygen consumption. However, there's a lack of research on subjective evaluation by participants. Thus, the study aims to compare the Intuy Knee with passive prostheses regarding functional outcomes and patient-reported outcomes (PROMs). The target group includes individuals with transfemoral amputation or knee disarticulation, aged 18 and above, with anticipated moderate to high mobility levels, and currently using an electronic prosthetic knee. The study plans to enroll participants nearing the end of their prosthetic cycle, allowing for comparison between different prosthetic options. Key objectives include comparing walking distance, stair climbing, and hill ascent between passive and active prostheses, as well as evaluating mobility, daily functionality, quality of life, and fear of falling. The study design is prospective with a pre-post design, aiming for an intra-individual comparison between active and passive prostheses. It outlines inclusion and exclusion criteria, study procedures, and discontinuation criteria for both individual and overall study termination.
Interventions
DEVICEactive microprocessor-controlled knee
Active microprocessor-controlled knees are motorized prosthesis, actively supporting the users while walking, getting up, and climbing stairs.
Sponsors
Johannes Gutenberg University Mainz
Median
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* transfemoral amputation or knee-disarticulation * passive microprocessor-controlled knee * resupply with new prosthesis within the next few months * K-Level 2 or 3 * body weight no more than 125 kg * German speakers
Exclusion criteria
* age less than 18 years * unable to give informed consent * body weight more than 125 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 minute walk test | baseline (t1), after 4 weeks (t2) | Subject walks for 6 minutes a defined track and covered track is reported as meters |
| Stair Assessment Index (SAI) | baseline (t1), after 4 weeks (t2) | Subjects walks up and down a stair 3 times, the investigator rates the performance on a scale from 0 (cannot to/refused to do) - 13 (without rail or assisstive device, step-over-step pattern) points |
| Hill Assessment Index (SAI) | baseline (t1), after 4 weeks (t2) | Subjects walks up and down a hill 3 times, the investigator rates the performance on a scale from 0 (cannot to/refused to do) - 11 (even step without assisstive device) points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EuroQol (EQ5D-5L) questionnaire | baseline (t1), after 4 weeks (t2) | Questionnaire assessing users´ quality of life. Users rate 5 statements with 1 (no agreement) to 5 (complete agreement) points. In addition, the users rate their perceived health on a scale from 0% - 100%. Results are presented as health utility scores. Minimum score is -0.661, maximum score is 1. |
| Timed Up and Go Test (TUG) | baseline (t1), after 4 weeks (t2) | Subjects gets up from a chair, walks 3 metres, turns, walks back to the chair, and sits down. The investigator records the time (seconds). |
| Fear of falling | baseline (t1), after 4 weeks (t2) | Subjects rate their fear of falling indoors and outdoors on a visual analogue scale. Minimum score is 0 (no fear) and maximum score is 10 (maximum fear). |
| Locomotor Capability Index 5 (LCI 5) | baseline (t1), after 4 weeks (t2) | Questionnaire assessing users´ locomotor abilities. Users rate statements with 0 (no) to 4 (yes, without any further assistance) points. Results are presented as basic activities (7questions) and advanced activities (7 questions). Minimum score is 0 points, maximum score is 28 points for each of the two categories. |
| Amputee Mobility Predictor with Prosthesis (AMP-PRO) | baseline (t1), after 4 weeks (t2) | Functional Assessment of 21 different tasks and evaluations. The investigator rates each tasks and sums up the score (min. 0; max. 47 points) |
| Prosthetic Limb User´s Survey of Mobility (PLUS-M) | baseline (t1), after 4 weeks (t2) | Questionnaire assessing users´mobility with 12 questions. Users rate their answers from 0 (not able to) to 5 (without any difficulties) points. Results are presented as t-scores from 23.1 - 65.7 |
Countries
Germany
Contacts
Primary ContactJohannes Schröter, Dr. med.
Outcome results
None listed