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Table 2 Schedule for data recording

From: PROPENSIX: pressure garment therapy using compressive dynamic Lycra® sleeve to improve bi-manual performance in unilateral cerebral palsy: a multicenter randomized controlled trial protocol

 

Inclusion visit, V1 (− 1 month)

Baseline visit, V2 (0 months*)

Control visit, V3 (3 months*)

End of study, V4 (6 months*)

Information and consent

X

   

Standard examination

 

X

X

X

Neuro-orthopedic examination

 

X

 

X

Inclusion and exclusion criteria verification

X

   

Randomization

X

   

Weight, height, blood pressure, pulse

X**

X

X

X

Arm measurement

X

   

AHA***

 

X

 

X

QUEST***

 

X

 

X

SEP***

 

X

 

X

PedsQL™ 3.0 CP Module

 

X

 

X

Adverse reactions report

  

X

X

Compliance evaluation

  

X

X

  1. AHA Assisting Hand Assessment, QUEST Quality of Upper Extremity Skill Test, PedsQL™ 3.0 CP Module Pediatric Quality of Life Inventory 3.0 Cerebral Palsy Module
  2. *+ 2 weeks
  3. **Weight and height only
  4. ***Assessments without wearing the splint
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Trials

ISSN: 1745-6215