Table 1

Overview of outcomes per measurement session

BaselineFollow-up
T1 measurement
(screening)
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
StabilityNRSXXX
Physical functioningSF36-PFXXX
Fear of fallingFESXXX
Fall rateQuestionnaireXXX
FatigueFSSXXX
SatisfactionD-QuestX†XX
Additional outcomes
DemographicsIntakeX
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.