Rehabilitation Program Dedicated to Post-stroke Lateropulsion Including Exoskeleton Assisted Exercises

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-84
SponsorUniversity Hospital, Grenoble

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • specific lateropulsion rehabilitation program (exoskeleton + specific physiotherapy orientation rehabilitation)

    Behavioral

    5 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

    Behavioral

    10 times a week, during 30-minutes

Treatment groups

3 Participants
are divided into 3 treatment groups
Group A: program week 2-3-4Experimental treatment 2 interventions
Group B: program week 3-4-5Experimental treatment 2 interventions
Group C: program week 4-5-6Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Daily, from enrollment to the end of treatment at 8 weeks

Secondary outcomes

1

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

Time frame
Once a week from enrollment to the end of program at 8 weeks
2

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

Time frame
once a week from enrollment to the end of treatment at 8 weeks
3

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

Time frame
once a week from enrollment to the end of treatment at 8 weeks
4

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.

Time frame
Daily, from enrollment to the end of treatment at 8 weeks

Other outcomes

Sponsors and contacts

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University Hospital, Grenoble

Lead sponsor

Fondation pour la recherche sur les AVC

Collaborator