Evaluation of a new powered knee prosthesis (Reboocon IntelLeg Knee)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

Individuals without an amputation
- Aged between 18 and 65.
- Body length between 1.20 and 1.95 m.
- Weight below 125 kg.
- Able to perform low to moderate vigorous physical activity for a duration of
3 hours including breaks., Individuals with an amputation
- Aged between 18 and 65.
- Weight below 125 kg.
- Body length between 1.20 and 1.95 m.
- Unilateral transfemoral amputation or knee disarticulation.
- Auto-adaptive or mechanical prosthesis user
- Functional level from K2 to K4
o Level 2: The patient has the ability 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
3 hours including breaks.
- Has finished rehabilitation and uses own prosthesis at home for more than 3
months.
- Willing to commit to a series of 4 training sessions to get adjusted to the
IntelLeg Knee.

Exclusion Criteria

Individuals without an amputation:
- Not willing to consent to participate in the study.
- Musculoskeletal problems influencing walking ability., Individuals with an
amputation:
- Not willing to consent to participate in the study.
- Other musculoskeletal problems influencing walking ability.
- Stump problems/bad socket fitting, Only for study I (for both individuals
with and individuals without amputation):
- For the second and third individual with amputation, subject*s weight differs
more than 15 kg of already included subject(s) or subject*s length differs
more than 15 cm of already included subject(s).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters/ endpoints of part I are the comparison of kinematics<br /><br>to normative data (Winter, 1984), the Borg-Scale (rate of perceived effort) for<br /><br>different control algorithms and different activities and are all sensory data<br /><br>from the IntelLeg Knee. These parameters will be used to determine the optimal<br /><br>controllers for the IntelLeg Knee.<br /><br>The main study parameter/ endpoints of part II are comparisons between baseline<br /><br>and intervention measurements, such as self-selected preferred walking speed,<br /><br>fastest walking speed, metabolic energy consumption during walking, uphill<br /><br>walking and stair negotiation, Borg-Scale (rate of perceived effort), relevant<br /><br>subscores of the Prosthesis Evaluation Questionnaire, the Hill Assessment<br /><br>Index, the Stair Assessment Index, the time to complete the L-test, TUG-test<br /><br>and time to complete the Four Square Step Test. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters/ endpoints of part I are videos recorded during<br /><br>the measurements.<br /><br>The secondary study parameters/ endpoints of part II are all sensory data from<br /><br>the IntelLeg Knee, classification accuracy of intent recognition algorithms<br /><br>using the IntelLeg Knee, kinematics (including left-to-right symmetry) and<br /><br>muscle activity (to assess significant changes between subject*s daily use<br /><br>prosthetic knee and the IntelLeg Knee)</p><br>