Table II. —Randomzied controlled trials.11, 13-18.
| Authors | Design | Sample | Age (mean±SD) & gender & Etiology |
Etiology | Length | Type of MPK | Main outcomes | Main results | Finding sources & COI |
|---|---|---|---|---|---|---|---|---|---|
| Theeven et al. 201111 | Crossover | 30 | 59.1±13.0 22 men |
23 trauma 6 vascular 1 tumor |
7 days of use (C-Leg, C-Leg Compact & mechanic) |
C-Leg & C-Leg-Compact | ADAPT circuit | 1. Time to complete ADAPT shorter for “intermediate” and “high” subgroups, for both MPKs 2. No difference for the group “low” |
Grant provided by otto Bock Healthcare GmbH, Vienna, Austria. The authors had the full and unrestricted right regarding: (i) the establishing of results of the investigation leading to scientifically corroborated conclusions; and (ii) the presentation of any result or conclusion resulting from the investigation, independent of any other party or grant provider. |
| Lura et al. 2015 Highsmith et al. 2016a,b,c Lura et al. 201713-17 |
Crossover | 20 | 46.5±14.2 16 men |
14 trauma 4 tumor 2 vascular |
2 weeks to 3 months (C-Leg & Genium) | C-Leg, Genium | 3D gait analysis, CS-PFP10, SAI, FSST, AMP, SAD-FL, DoA | 1. Genium knee increased flexion in swing and stance 2. Genium knee improved upper-body flexibility, balance, and endurance, measured with the CS-PFP10. 3. Mean stair completion times and descent stepping rate were not different between knees. 4. Stair ascent stepping rate for C-Leg was greater compared to Genium 5. FSST was faster for Genium 6. AMP and SAD-FL increased for Genium 7. DoA improved for Genium |
Support from the Florida High Tech Corridor/University of Southern Florida Connect and Ottobock Healthcare. The sponsors had no role in the study design, manuscript writing, or decision to submit the manuscript for publication. The authors have declared that no competing interests exist. |
| Lansade et al. 201818 | Crossover | 35 | 65.6±10.1 27men |
20 vascular 4 diabetic 8 trauma 4 tumor 3 infection |
MPK: 3m NMPK: 1m |
Kenevo, OttoBock | TUG, LCI-5, falls & SF-36 | 1. TUG was shorter for MPK 2. LCI-5 improved for MPK 3. No difference for number of falls 4. SF-36 was better for MPK |
The sponsor provided MPK devices for the study, training sessions for ortho-prosthetists and rehabilitation teams, and support to monitor the multi-centric study according to the planning defined in the protocol. The sponsor had no role in the design of this study, defined by an independent scientific advisory board, and no role in data collection, data treatment and data analysis. |
AMP: Amputee Mobility Predictor; ADAPT: Assessment of daily activity performance in transfemoral amputees; COI: conflict of interest; CS-PFP10: Continuous Scale of Physical Functional Performance; DoA: degree of asymmetry; FSST: Four Square Step Test; LCI: Locomotor Capability Index; MPK: microprocessor-controlled knees; NMPK: non microprocessor-controlled knees; SAI: Stair Assessment Index; SAD-FL: step activity derived functional level; SF-36: Short-Form 36; TUG: timed-up and go.