Gait and user experiences of the NEURO TRONIC stance-control knee-ankle-foot orthosis (SC-KAFO): a comparative evaluation to the E-MAG Active SC-KAFO.

Gait and user experiences of the NEURO TRONIC stance-control knee-ankle-foot orthosis (SC-KAFO): a comparative evaluation to the E-MAG Active SC-KAFO. - Gait and user experiences with the NEURO TRONIC SC-KAFO.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50174

Enrollment

Registered

2018-01-11

Start date

2018-03-14

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

flaccid paresis

Interventions

The intervention includes a custom-made stance control knee-ankle-foot orthosis (SC-KAFO) with the NEURO TRONIC system knee-joint build in. NEURO TRONIC SC-KAFOs will be prescribed and fabricated by

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - using an E-MAG Active SC-KAFO at least when walking outside and that is not defective; - age between 18 and 80 years; -

Exclusion criteria

Exclusion criteria: - no indication for a SC-KAFO upon examination (e.g. due to sufficient quadriceps strength).

Design outcomes

Primary

Measure	Time frame
For objective 1, the main study endpoint will be securing of the knee-joint while walking under challenging conditions, as measured during a perturbation walk test on the instrumented C-Mill treadmill. For objective 2, the main endpoint will be walking energy cost (measured with a 6-minute walk test at comfortable speed with simultaneous gas-analysis).	—

Secondary

Measure	Time frame
Secondary endpoints include spatiotemporal parameters and joint angles and net joint moments during gait (measured by a 3D gait analysis), and user experiences with the SC-KAFO (measured with a questionnaire).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)