Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure
Study period | ||||||
|---|---|---|---|---|---|---|
Enrolment | Allocation | Post allocation | Close-out | |||
Time point | Baseline | Intervention | P1 4 weeks post | P2 12 weeks post | P3 24 weeks post | |
Enrollment: | ||||||
Eligibility screen | x | |||||
Informed consent | x | |||||
Allocation | x | |||||
Interventions: | ||||||
Saline | x | |||||
Botulinum toxin A | x | |||||
Assessments: | ||||||
Energy cost | x | x | x | x | ||
Habitual physical activity | x | x | x | x | ||
Pain | x | x | x | x | ||
Perceived change in performance and satisfaction | x | x | x | x | ||
Spasticity test | x | x | x | x | ||
Passive range of motion in the ankle | x | x | x | x | ||