flaccid paresis muscle disease
Conditions
Interventions
Participants will receive a new AFO that will be adjusted into five stiffness
configurations (range: very flexible - very stiff). For each individual
patient, the optimal AFO configuration will be s
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -age between 18 and 80 years; -weakness of the calf muscles (i.e. a MRC score 3 heel rises); -using an AFO or orthopedic boot (one or both sided); -able to walk for 5 minutes, with or without walking aids; -able to walk for 10m barefoot without assistive devices.
Exclusion criteria
Exclusion criteria: -presence of pes equinus under weight-bearing (dorsiflexion * 0º); -severe deformity of the ankle/foot that cannot be fitted with a custom-made AFO; -severe weakness of the upper legs requiring a knee-ankle-foot orthosis; -body weight > 120 kg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint will be walking effort (ECW), which will be measured during a 6-minute walk test (6MWT) with simultaneous gas-analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints will include: joint angles and net joint moments during gait (measured by 3D gait analysis); walking speed (assessed with a 6MWT); perceived physical functioning (assessed with the 36-Item Short-Form Health Survey questionnaire); perceived fatigue (measured with the Fatigue Severity Scale); daily step activity (measured with the StepWatch3TM Activity Monitor 3.0 + a motivation dairy); and satisfaction (evaluated on a 10-point Numeric Rating Scale). Additional endpoints will include isometric strength and passive stiffness characteristics of the calf muscles; visualization of the fiber architecture of the calf muscles, assessed with diffusion-tensor magnetic resonance imaging; the AFO stiffness and treatment adherence. | — |
Countries
Netherlands
Outcome results
None listed