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Table 3 Schedule for the assessment of primary and secondary outcomes

From: Dual-task versus single-task gait rehabilitation after stroke: the protocol of the cognitive-motor synergy multicenter, randomized, controlled superiority trial (SYNCOMOT)

 

Recruitment

Inclusion M0

Follow-up visit at M1

Follow-up visit at M2

Follow-up visit at M6

Investigator

Patient information

✓

    

Informed consent

 

✓

   

Demographic dataa

 

✓

   

Randomization

 

✓

   

Gait classification

 

✓

   

Strokeb

 

✓

   

NIHSS

 

✓

✓

✓

✓

Fugl-Meyer (lower limb)c

 

✓

✓

✓

✓

FIM

 

✓

✓

✓

✓

mRS-SI

 

✓

✓

✓

✓

QoL-VAS

 

✓

✓

✓

✓

AEs and SAEs

  

✓

✓

✓

Therapists

ST 10 MWT

 

✓

✓

✓

✓

DT 10 MWT

 

✓

✓

✓

✓

ST TUG

 

✓

✓

✓

✓

DT TUG

 

✓

✓

✓

✓

Neuropsychologist

Neuropsychological batteryd

 

✓

✓

✓

✓

Radiologist

MRI

✓ 280 patients in 12 centers (4 and 6 months after stroke)

fMRI and fMRS

✓ 20 patients at the Amiens center (4 and 6 months after stroke)

  1. aAge, sex, handedness, and comorbidities (bladder disorders and neuro-orthopedic complications)
  2. bStroke site, side, and type (ischemic or hemorrhagic)
  3. cThe motor part of the Fugl-Meyer Assessment of the lower extremity [47]
  4. dAssessment of neuropsychological cognitive abilities, using the French adaptation [29] of the Harmonization Standards protocol [48]; assessment of behavioral dysexecutive disorders, using the previously validated Behavioral Dysexecutive Syndrome Inventory) [49]
  5. NIHSS National Institutes of Health Stroke Scale, FIM the Functional Independence Measure [50], mRS-SI a structured interview with a modified Rankin score [51], QoL-VAS visual analog scale for quality of life, AE adverse event, SAE serious adverse event, ST 10MWT single-task 10-meter walk test [52, 53], DT 10MWT dual-task 10-m walk test, with four cognitive tasks during gait, the verbal Trail-Making Test (executive function), a symbol praxis task, a literal fluency task, and a verbal serial recall task (short-term memory), ST TUG single-task timed up-and-go test, DT TUG dual-task timed up-and-go test, with four cognitive tasks during gait, the verbal Trail-Making Test (executive function), a symbol praxis task, a literal fluency task, and a verbal serial recall task (short-term memory), MRI magnetic resonance imagery, fMRI functional MRI, fMRS functional magnetic resonance spectroscopy