Transfemorale amputatie (als gevolg van bijvoorbeeld trauma of diabetes) 'Amputation' and 'Lower limb loss'
Conditions
Interventions
Part I of the study is designed as an intervention study with A the baseline
measurement (subject*s own prosthesis) and B the intervention (IntelLeg Knee).
Part II of the study is designed as an A-B
Sponsors
Reboocon Bionoics (medeverrichter naast de Universiteit Twente)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: (Preferably, the subjects have already participated in a previous study and are familiar with the IntelLeg Knee.) - Aged between 18 and 65. - Weight below 125 kg. - Body length between 1.51 and 1.95 m. - Unilateral transfemoral amputation or k nee disarticulation. - Functional level from K2 to K4 o Level 2: The patient has the a bility or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator. o Level 3: The patient has the ability or potential for ambulation with variable cadence. Typical of the community ambulatory who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion. o Level 4: The patient has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete. - Able to perform low to moderate vigorous physical activity for a duration of 2 hours including breaks. - At least one year after amputation.
Exclusion criteria
Exclusion criteria: - Not willing to consent to partic ipate in the study. - Other musculoskeletal problems influencing wal king ability. - Stump problems/bad socket fitting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters for the first part of the study are joint kinetics and joint load and induced acceleration analyses, obtained through musculoskeletal simulations. Left-to-right symmetry mean and peak values and the timing of peak values will be evaluated between the prostheses, as well as comparing them to literature. For the second part of the study the study parameters are the same, now comparing the analyses only for level-walking for the IntelLeg Knee before and after subject specific parameter adjustment and gait instructions, using the daily prosthesis as reference. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed