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Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure

From: The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial

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