Overview of measurements per visit
| T1cast Visit 1 | T1fit Visit 2 | T2k-3DGA* Visit 3 | T2k-6MWT* Visit 4 | T2deliver Visit 5 | T3k-opt Visit 6 | ||
|---|---|---|---|---|---|---|---|
| Primary outcome | |||||||
| Walking effort | 6MWT | x | x | x | |||
| Secondary outcomes | |||||||
| Gait biomechanics | 3DGA† | x | x | ||||
| Walking speed | 6MWT | x | x | x | |||
| Physical functioning | SF36 | x | x | ||||
| Perceived fatigue | FSS | x | x | ||||
| Daily step activity | SAM‡ | x | x | ||||
| Adherence | ODM‡ | x | x | ||||
| Satisfaction | NRS | x | x | x | |||
| LiS | x | ||||||
| Additional outcomes | |||||||
| Demographics | Intake | x | |||||
| Anthropometrics | PE | x | |||||
| Muscle strength | Biodex | x | |||||
| Muscle quality§ | DTI | x | |||||
| AFO stiffness | BRUCE | x | |||||
*T2k will be repeated for each of the five AFO-stiffness configurations (range: very flexible to very stiff).
†3DGA at T1 will be performed during the T2k-3DGA visit. Conditions that will be assessed include walking barefoot; walking with shoes, walking with the old AFO and walking with the test AFO in five configurations.
‡SAM and ODM data at T1/T3 will be assessed in the week prior to the ticked measurement moment.
§Muscle quality includes intramuscular fat fraction, intramuscular fluid content and skeletal muscle architecture.
AFO, ankle-foot orthosis; cast, casting of AFO; DTI, diffusion tensor imaging; fit, fitting of AFO; FSS, Fatigue Severity Scale; k-3DGA, 3D gait analysis for all stiffness conditions; k-6MWT, 6-min walking test for all stiffness conditions; LiS, Likert Scale; NRS, Numeric Rating Scale; ODM, adherence to treatment monitor; PE, physical examination; SAM, StepWatch3 Activity Monitor; SF36, 36-Item Short-Form Health Survey; 6MWT, 6-min walk test; T2deliver, visit where optimal AFO is given to the patient; T3k-opt, follow-up visit with optimal AFO; 3DGA, 3-dimensional gait analysis.