Overview of outcomes per measurement session
| Baseline | Follow-up | |||
| T1 measurement (screening) | T2 measurement (12 weeks after delivery) | T3 measurement (24 weeks after delivery) | ||
| Primary outcomes | ||||
| Walking energy cost | 6 MWT | X | X | X |
| Personal goals | GAS | Setting goals | X | X |
| Secondary outcomes | ||||
| Walking speed | 6 MWT | X | X | X |
| Gait biomechanics | 3DGA | X* | X | X |
| Stability | NRS | X | X | X |
| Physical functioning | SF36-PF | X | X | X |
| Fear of falling | FES | X | X | X |
| Fall rate | Questionnaire | X | X | X |
| Fatigue | FSS | X | X | X |
| Satisfaction | D-Quest | X† | X | X |
| Additional outcomes | ||||
| Demographics | Intake | X | ||
| Anthropometrics | Physical exam | X | ||
| Muscle strength | Physical exam | X | ||
| Joint passive range of motion | Physical exam | X | ||
| Sensory function | Physical exam | X | ||
| Orthotic properties | CRF | X† | X | X |
| Adverse events | CRF | X | X | |
| Economic evaluation | ||||
| Resource use‡ | Cost questionnaire | X | X | X |
| Health-related quality of life‡ | EQ-5D-5L | X | X | X |
*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.