About this trial
Lateropulsion is a deficit in the body orientation with respect to the vertical in the coronal plane, defined by the presence of one of the three signs: lateral body tilt, active pushing from the sound limbs, and resistance to passive corrections. The lateral body tilt is the cardinal sign, the frequency of the 2 other signs increasing with lateropulsion severity (most dramatic forms called pusher syndrome in the past). Lateropulsion is frequent after stroke, and represents the main factor underpinning balance and gait disorders at the subacute phase. After hemisphere stroke lateropulsion is caused by a bias in the internal model of the verticality in the frontal plane, individuals unconsciously aligning their body posture on a tilted verticality representation. Pilot studies suggested the possibility to recalibrate the internal model of verticality, biased by stroke, and to improve individuals' uprightness. The investigators expect that a specific rehabilitation program combining technics devoted to lateropulsion, and comprising exoskeleton (Atalante) assisted balance exercises could help recalibrate the internal model of verticality and alleviate lateropulsion. The primary objective is to test the hypothesis that a 3-week specific lateropulsion rehabilitation program (15 sessions of 30 minutes including exoskeleton and a rehabilitation focused on the vertical body orientation in the frontal plane) improves the visual vertical (VV), the most used test to assess verticality perception.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Right hemispheric first and unique ischemic stroke between 2 weeks and 6 months old (subacute phase) ;
Presence of lateropulsion, assessed by the Scale for Contraversive Pushing (2 ≤ SCP < 5)
Presence of contralesional VV bias (VV > 4°)
Right handedness defined by a Edinburgh score ≥0,39
Disqualifiers
Medical instability making evaluation impossible,
Comprehension or cognitive or behavioral disorders, or depressive symptoms that compromise participation in the program
Postural disorders or body geometry disorders that interfere with balance for a reason that is independant of the stroke
Morphological contraindications to the use of the Atalante® robot (segment length or joint ranges; height <155cm; weight >100kg),
Trial design
Single group
Treatments tested in this trial
specific lateropulsion rehabilitation program (exoskeleton + specific physiotherapy orientation rehabilitation)
Behavioral5 times a week during 30 minutes sessions = 15 Physiotherapy sessions, focused on the active vertical body orientation in the frontal plane and comprising exoskeleton-assisted balance and gait exercises. \+ 5 times a week during 30 minutes sessions = 15 conventional physiotherapy without exercises dedicated to lateropulsion or verticality representation alleviation The intervention description is more extensive in the study description section
Conventional physiotherapy without without exercises dedicated to lateropulsion or verticality representation alleviation
Behavioral10 times a week, during 30-minutes
Treatment groups
Trial outcomes
Primary outcomes
Visual Vertical (VV) Orientation
VV consists in testing the direction of a visual line, perceived as vertical by participants, in complete darkness. VV will be tested by a well-validated apparatus and paradigm (Pérennou et al Brain 2008 ; Piscicelli \& Pérennou 2017). VV orientation will be the average orientation (in degree) of the 10 trials performed. Higher score means a worse outcome, indicating the magnitude of the bias in verticality perception.
Secondary outcomes
Postural Vertical (PV) orientation and uncertainty
PV consists in testing the whole body orientation in sitting, perceived as vertical by participants, in complete darkness. PV will be tested by a well-validated apparatus and paradigm (Pérennou et al Brain 2008). PV orientation will be the average orientation (in degree) of the 10 trials performed ; PV uncertainty is the standard deviation of the 10 trials performed in degrees. Higher scores mean worse outcomes, indicating the magnitude of the bias in verticality perception
Lateropulsion severity assessed by SCALA
The SCAle for LAteropulsion (SCALA) scores range from 0 (no lateropulsion) to 50 (severe lateropulsion with pushing); higher scores mean a worse outcome
Lateropulsion severity assessed by SCP
The SCP (= clinical Scale for Contraversive Pusching, Karnath et al. (2000)) scores range from 0 (no lateropulsion) to 6 (severe lateropulsion with pushing); higher scores mean a worse outcome
Visual Vertical Uncertainty
VV consists of testing the direction of a visual line, perceived as vertical by particpants, in complete darkness. VV will be tested by a well-validated apparatus and paradigm (Pérennou et al Brain 2008 ; Piscicelli \& Pérennou 2017). VV uncertainty will be the standard deviation of the 10 trials performed in degrees. Higher score means a worse outcome.
Sponsors and contacts
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University Hospital, Grenoble
Lead sponsor
Fondation pour la recherche sur les AVC
Collaborator