Table 2

Overview of measurements per visit

Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit 6
Primary outcome
 Walking effort6MWTxxx
Secondary outcomes
 Gait biomechanics3DGA†xx
 Walking speed6MWTxxx
 Physical functioningSF36xx
 Perceived fatigueFSSxx
 Daily step activitySAM‡xx
Additional outcomes
 Muscle strengthBiodexx
 Muscle quality§DTIx
 AFO stiffnessBRUCEx
  • *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.