Neuromuscular diseases, Neuromuscular disorders, Charcot Marie Tooth, foot slap, tibialis anterior weakness Muscle diseases
Conditions
Interventions
The new personalised AFO with the “Rise” mechanism is the intervention (Rezolve Medical, Amsterdam, the Netherlands). During the first visit, a 3D-scan will be made. This scan is used to produce and t
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age >18 years Having dorsiflexor weakness (i.e. Medical Research Center (MRC) Scale for Muscle Strength 0-4) in at least one leg [14].Ability to perform at least 3 single-leg heel-rises with the affected leg(s), to ensure participants have no functional calf muscle weaknessAble to walk independently without AFO for at least 50 meters (with assistive device (eg. crutch), if necessary)
Exclusion criteria
Exclusion criteria: Prior AFO useSignificant foot or ankle deformities that cannot be fitted with an AFO with “Rise” mechanism or prefabricated carbon AFOUpper leg muscle weakness as defined by an MRC-scale <5Severe spasticity of the leg muscles as defined by Modified Ashworth Scale >2 [16]Unable to use compatible shoes for an an AFO with “Rise” mechanism or prefabricated carbon AFO for the duration of the researchConditions requiring immobilization of the ankle joint at 90 degreesRecent (within 3 months) botulinum toxin injections in the lower limbsRecent (within 6 months) surgery on the lower limbs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: sagittal plane ankle angle during swing will be measured using a 3D gait analysis. User satisfaction with the AFO with “Rise” mechanism and the prefabricated carbon AFO will be measured using the Client Satisfaction with Device (CSD) module of the Orthotics and Prosthetics Users’ Survey (OPUS). | — |
Secondary
| Measure | Time frame |
|---|---|
| ankle angle during loading response, ankle push-off power, knee/hip kinematics during swing, gait symmetry and walking speed, all measured using a 3D gait analysis. AFO adherence during home use will be measured by the Orthotimer®, which will be built into the AFO and can measure when the AFO is worn. | — |
Countries
Netherlands
Contacts
Public ContactNFJ Waterval
Amsterdam UMC
Outcome results
None listed