Extended evaluation of a new powered knee prosthesis (Reboocon IntelLeg Knee) through musculoskeletal simulations
- Conditions
- Transfemorale amputatie (als gevolg van bijvoorbeeld trauma of diabetes)'Amputation' and 'Lower limb loss'
- Registration Number
- NL-OMON52009
- Lead Sponsor
- Reboocon Bionoics (medeverrichter naast de Universiteit Twente)
- Brief Summary
Trial ended prematurely
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
(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.
- Not willing to consent to partic ipate in the study.
- Other musculoskeletal problems influencing wal king ability.
- Stump problems/bad socket fitting
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters for the first part of the study are joint kinetics<br /><br>and joint load and induced acceleration analyses, obtained through<br /><br>musculoskeletal simulations. Left-to-right symmetry mean and peak values and<br /><br>the timing of peak values will be evaluated between the prostheses, as well as<br /><br>comparing them to literature. For the second part of the study the study<br /><br>parameters are the same, now comparing the analyses only for level-walking for<br /><br>the IntelLeg Knee before and after subject specific parameter adjustment and<br /><br>gait instructions, using the daily prosthesis as reference. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable. </p><br>