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Table 1 Tests and evaluations during each visit

From: Effect of botulinum toxin injection on length and force of the rectus femoris and triceps surae muscles during locomotion in patients with chronic hemiparesis (FOLOTOX)

Tests and evaluations

V1

V2

V3

V4

Inclusion/ exclusion criteria

X

   

Informed consent

X

   

Randomisation

X

   

Injection BTX-A or placebo

 

X

  

Evaluation of passive range of motion (MG)

X

 

X

X

Evaluation of spasticity (MAS)

X

 

X

X

Evaluation of strength (MRS)

X

 

X

X

SF 36

X

 

X

X

FIM

X

 

X

X

ABILOCO scale

X

 

X

X

Berg balance scale

X

 

X

X

Abc scale

X

 

X

X

Timed up and go

X

 

X

X

3D analysis

X

 

X

X

Isokinetic evaluation

X

 

X

X

  1. V1 visit 1, V2 visit 2, V3 visit 3, V4 visit 4, MA manual goniometer, MAS modified Ashworth, MRC Medical Research Council, SF36 The Short Form (36) Health Survey, FIM Functional independence measure, 3D analysis gait motion analysis. All outcome measures will be evaluated during the first visit (baseline-V1) and 1 month (V3) and 3 (V4) months after injection. All evaluations will be performed in the same order at each session in order to limit bias related to fatigue