Table 1

Overview of outcomes per measurement session

T1 measurement
T2 measurement
(12 weeks after delivery)
T3 measurement
(24 weeks after delivery)
Primary outcomes
Walking energy cost6 MWTXXX
Personal goalsGASSetting goalsXX
Secondary outcomes
Walking speed6 MWTXXX
Gait biomechanics3DGAX*XX
Physical functioningSF36-PFXXX
Fear of fallingFESXXX
Fall rateQuestionnaireXXX
Additional outcomes
AnthropometricsPhysical examX
Muscle strengthPhysical examX
Joint passive range of motionPhysical examX
Sensory functionPhysical examX
Orthotic propertiesCRFX†XX
Adverse eventsCRFXX
Economic evaluation
Resource use‡Cost questionnaireXXX
Health-related quality of life‡EQ-5D-5LXXX
  • *Gait analysis conditions at baseline that will be used for statistical analysis concern walking with shoes only or walking with the old orthosis (in case a participant uses an orthosis at baseline).

  • †Outcomes will only be assessed in case a participant uses an orthosis at baseline.

  • ‡Outcomes for the economic evaluation will also be assessed directly after delivery of the orthosis.

  • CRF, clinical report form; 3DGA, 3-dimensional gait analysis; D-Quest, Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology; EQ-5D-5L, 5-Level version of EuroQol 5D; FES, Falls Efficacy Scale; FSS, Fatigue Severity Scale; GAS, Goal Attainment Scale; 6MWT, 6-minute walk test; NRS, Numeric Rating Scale; SF36-PF, Physical Functioning Scale of the Short-Form Health Survey.