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

NCT07023770 | Not Yet Recruiting

• 2 other identifiers: 38RC24.02542024-A01586-41
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke, Ischemic

Keywords

lateropulsion; exoskeleton; rehabilitation program

Outcome Measures

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.

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

Secondary Outcomes (15)

• Postural Vertical (PV) orientation and uncertainty

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

• Lateropulsion severity assessed by SCALA

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

• Lateropulsion severity assessed by SCP

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

• Visual Vertical Uncertainty

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

• specific post-effect of one exoskeleton session on visual vertical

  once a week during the 3 lateropulsion program weeks

Study Arms (3)

program week 2-3-4

EXPERIMENTAL

For the participant included in this arm, the intervention will take place during weeks 2-3-4 (5 times per week 30-min sessions with specific physiotherapy targeting lateropulsion including exercices in exoskeleton + 5 times per week conventional physiotherapy). During weeks 1, 5, 6, 7 \& 8, 30-min sessions of conventional physiotherapy will take place 10 times per week. The rest of the rehabilitation (speech therapy, neuropsychology, occupational therapy) will be provided as usual.

Behavioral: specific lateropulsion rehabilitation program (exoskeleton + specific physiotherapy orientation rehabilitation); Behavioral: Conventional physiotherapy without without exercises dedicated to lateropulsion or verticality representation alleviation

program week 3-4-5

EXPERIMENTAL

For the participant included in this arm, the intervention will take place during weeks 3-4-5 (5 times per week 30-min sessions with specific physiotherapy targeting lateropulsion including exercices in exoskeleton + 5 times per week conventional physiotherapy). During weeks 1, 2, 6, 7 \& 8, 30-min sessions of conventional physiotherapy will take place 10 times per week. The rest of the rehabilitation (speech therapy, neuropsychology, occupational therapy) will be provided as usual.

Behavioral: specific lateropulsion rehabilitation program (exoskeleton + specific physiotherapy orientation rehabilitation); Behavioral: Conventional physiotherapy without without exercises dedicated to lateropulsion or verticality representation alleviation

program week 4-5-6

EXPERIMENTAL

For the participant included in this arm, the intervention will take place during weeks 4-5-6 (5 times per week 30-min sessions with specific physiotherapy targeting lateropulsion including exercices in exoskeleton + 5 times per week conventional physiotherapy). During weeks 1, 2, 3, 7 \& 8, 30-min sessions of conventional physiotherapy will take place 10 times per week. The rest of the rehabilitation (speech therapy, neuropsychology, occupational therapy) will be provided as usual.

Behavioral: specific lateropulsion rehabilitation program (exoskeleton + specific physiotherapy orientation rehabilitation); Behavioral: Conventional physiotherapy without without exercises dedicated to lateropulsion or verticality representation alleviation

Interventions

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

program week 2-3-4; program week 3-4-5; program week 4-5-6

Conventional physiotherapy without without exercises dedicated to lateropulsion or verticality representation alleviation BEHAVIORAL

10 times a week, during 30-minutes

program week 2-3-4; program week 3-4-5; program week 4-5-6

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Being hospitalized in a Physical Medicine and Neurological Rehabilitation (PMR) facility.
• Have given a written and informed consent

You may not qualify if:

• 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),
• Severe spasticity (\>3 on the modified Ashworth scale) in the adductors, quadriceps, hamstrings and triceps surae
• Presence of a pressure sore at the areas of contact with the Atalante® robot,
• History of osteoporotic fractures.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Fondation pour la recherche sur les AVC: collaborator

Study Sites (2)

Grenoble University Hospital

Échirolles, France

Location

Grenoble University Hospital

Grenoble, 38043, France

Location

Related Publications (26)

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• Odin A, Faletto-Passy D, Assaban F, Perennou D. Modulating the internal model of verticality by virtual reality and body-weight support walking: A pilot study. Ann Phys Rehabil Med. 2018 Sep;61(5):292-299. doi: 10.1016/j.rehab.2018.07.003. Epub 2018 Jul 19.

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• Dieterich M, Brandt T. Wallenberg's syndrome: lateropulsion, cyclorotation, and subjective visual vertical in thirty-six patients. Ann Neurol. 1992 Apr;31(4):399-408. doi: 10.1002/ana.410310409.

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MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dominic Pérennou, MD, PhD, Pr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominic Pérennou, MD, PhD, Pr

CONTACT

+334 76 76 60 83; dperennou@chu-grenoble.fr

Eugénie Lhommée, MPsych

CONTACT

+334 76 76 60 60; elhommee@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multiple baseline designs of a " single case experimental design " applied in 3 participants.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: June 17, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After seminal publication of the results
• Access Criteria: Anonymized data that support the findings of this study will be available from the principal investigator (Pr Dominic Pérennou), upon reasonable request, only for authorized research. Their use is subjected to an agreement with the promotor (CHU Grenoble) and the principal investigator of the EXOLAT study

Locations

FR (2)