An interventional study of specific lateropulsion rehabilitation program (exoskeleton + specific physiotherapy orientation rehabilitation) and Conventional physiotherapy without without exercises dedicated to lateropulsion or verticality representation alleviation in Stroke, Ischemic, sponsored by University Hospital, Grenoble. Recruiting at 2 sites in France. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment
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Among 164 studies in Ischemic Stroke with a site in France — 56 open to participants now, 61 under way, 10 of them phase 3. Ischemic Stroke · France.
Among the 164 studies in Ischemic Stroke with a site in France, this one is the 107th largest by planned enrollment of the 109 interventional ones that give a count, is one of 15 that started in 2025, is one of 58 with no phase, reaches primary completion later than 16 of the 60 other live ones, and was the 149th registered.
2,619 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.
Browse Ischemic Stroke studies →56 of the 164 studies in Ischemic Stroke with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Universitaire Dijon · Sites in France
Ages 18+
Takeda · Sites in France, United States, Belgium and 7 more countries
Ages 18+
Centre Hospitalier Universitaire de Nice · Sites in France
Ages 18–80
University Hospital, Clermont-Ferrand · Sites in France
Ages 18+
Neuravi Limited · Sites in France, Belgium, Germany and 1 more country
Ages 18–90
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 661 Ischemic Stroke studies recruiting now, 396 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 42 take healthy volunteers.
This study: 18 Years to 84 Years · all sexes · no healthy volunteers.
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164 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 25 · Phase 3 25 · Phase 4 4
First in 1990; this study’s year is marked. 15 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 3 is below the median of 120 across 1,780 interventional studies indexed under Ischemic Stroke.
Median enrollment 186 across the 109 interventional studies, 250 across the 55 observational. Of the 91 that completed or were terminated, 13 (14%) have results posted.
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44 of 164 have an industry lead sponsor. The 10 most frequent:
University Hospital, Grenoble is the lead sponsor of 838 studies on the registry; 208 are open to participants now.
University Hospital, Grenoble has 4 studies filed under Ischemic Stroke — fewer than ten, so there is no comparison to draw.
15 of the studies in Ischemic Stroke with a site in France that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05065216Phase 3DiaMedica Therapeutics IncTreatment of Acute Ischemic Stroke (ReMEDy2 Trial) | 2026-12 |
| NCT06059144Phase 3University Hospital, BordeauxInduced Hypertension in Acute PRogrESsive Perforating Artery Stroke Using Peripheral Dilute noREpinephrine | 2027-08-28 |
| NCT05476991Phase 3Assistance Publique - Hôpitaux de ParisEvaluation of Low Dose Colchicine and Ticagrelor in Prevention of Ischemic Stroke in Patients With Stroke Due to Atherosclerosis | 2027-09-01 |
| NCT06071091Assistance Publique - Hôpitaux de ParisPermanent Intracranial Stenting for Acute Ischemic Stroke Related to a Refractory Large Vessel Occlusion | 2027-02-01 |
| NCT06823466University of L'AquilaAdvancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants | 2027-02-12 |
Add all 15 to your calendar (.ics) → With an account.
Among the 164 studies in Ischemic Stroke with a site in France, from their registry updates:
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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.
BACKGROUND To our knowledge, no study has ever assessed the effects of a rehabilitation program specifically devoted to lateropulsion. The investigators expect that such a specific program combining different technics selected on the basis of theoretical rationale, experimental evidence in healthy subjects, or phase I-II randomized clinical studies, and supposed to improve verticality representation or alleviate lateropulsion could improve verticality representation and alleviate lateropulsion. The investigators hypothesize that individuals with moderate to severe lateropulsion after hemisphere stroke could benefit from such a specific lateropulsion rehabilitation program.
OBJECTIVES The primary objective is to test the hypothesis that, in individuals with a first ischemic right hemisphere stroke showing a moderate to severe lateropulsion due to a biased internal model of verticality, a 3-week intensive specific and intensive lateropulsion rehabilitation program (15 physiotherapy sessions of 30 minutes including exoskeleton-assisted lateral balance exercises) improves the visual perception of the verticality as assessed by the Visual Vertical (VV) orientation. This outcome has been selected because it may be repeatedly assessed, which is necessary in a Small-N design Study.
The secondary objectives are to:
HYPOTHESES Considering the main objective, the investigators hypothesize that the specific and intensive lateropulsion rehabilitation program will improve VV orientation of at least 2°, constituting a real change in VV perception.
STUDY DESIGN The study is a monocentric Small-n design study. The experimental plan is a multiple baseline design. This design applies for intervention with slow/delayed changes and no expected washout. Three participants will be included after about the same time post stroke (subacute phase). The VV will be measured daily (except on weekends) for each participant (i.e. 5 VV per week ), and the generalization and control measures measured once each week. All participants will follow a conventional rehabilitation program until they start the intervention.
The first participant will start the intervention period 2 weeks after enrolment. The second will start at 3 weeks after enrolment and the last one will start at 4 weeks after enrolment. All participants will be assessed repetitively on the target variables. The sequential introduction of the intervention in 3 participants will allow the visualization of lack of retest effect and of progress unrelated to intervention in the individuals not having the intervention yet.
INTERVENTION
During the baseline and after the 3-week intervention, individuals will follow the conventional rehabilitation program including :
During the 3-week intervention, individuals will have:
During the specific rehabilitation program, the frame of exercises with the Atalante® exoskeleton comprises verticalization: work in standing position, stepping, walking in different directions including backward, with the help of a mirror or without visual information (eyes closed). Some exercises in the exoskeleton will also be performed when the participant is laterally tilted (in a static position, during active functional tasks, eyes open and closed).
The specific physiotherapy rehabilitation targeting lateropulsion will include: verticality awareness, exercises in front of a mirror to facilitate the awareness of body tilt (or with a video record), posturography with biofeedback, trunk inclination, reaching tasks in sitting and standing position, walking with body-weight support, orientation tasks during sensorial ponderation (eyes open/closed, foam or firm surface, cervical extension...) The investigators chose not to include brain stimulation in this program.
PARTICIPANTS Three patients will be included. The study will be explained to eligible individuals who will be free to participate or not. An informed consent form will then be signed by each participant.
To meet the scientific standards of SCEDs, one required design criteria is to include at least three attempts to demonstrate an intervention effect (i.e. 3 participants in our case). The sequential introduction of the intervention in 3 participants will allow the visualization of effect of the intervention on the VV.
RELEVANCE Regaining independent balance and mobility is a major goal in post-stroke rehabilitation. While lateropulsion due to a biased internal model of verticality is one of the most important detrimental factors affecting balance and gait at the post-stroke subacute phase, no specific lateropulsion rehabilitation program has ever been scientifically validated with a high level of evidence. This study will focus on individuals with moderate to severe lateropulsion caused by a biased internal model of verticality due to a right hemisphere stroke which are known to have lesser recovery and longer hospital length of stay. A specific and intensive lateropulsion rehabilitation program dedicated to the active vertical body orientation in the frontal plan could speed up the mobility recovery and shorten the hospitalization period.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
10 times a week, during 30-minutes
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
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
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
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
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
specific post-effect of one exoskeleton session on visual vertical
orientation of VV in degrees, a higher score indicate a higher verticality perception biais. 15 minutes max after exoskeleton session.
Time frame: once a week during the 3 lateropulsion program weeks
Lower limb motricity assessed by "Fugl-Meyer Assessment of Motor Recovery after Stroke"
Motor score of lower extremity ranges from 0 (hemiplegia) 34 points (normal motor performance). A higher score means a better outcome.
Time frame: once a week from enrollment to the end of treatment at 8 weeks
Balance assessed by the modified Postural Assessment Scale for Stroke (mPASS) total score
The modified Postural Assessment Scale for Stroke patient (m-PASS) scores range from 0 (poorer balance ability) to 50 (excellent balance ability). Higher scores mean a better outcome.
Time frame: once a week from enrollment to the end of the study at week 8
Gait assessed by Modified Fugl-Meyer Gait Assessment total score
Modified Fugl-Meyer Gait Assessment score ranges from 0 (not able to walk) to 6 (walks at a normal speed for his age). Higher score means better outcome (Lindmark 1988).
Time frame: once a week from enrollment to the end of the study (week 8)
Functionnal mobility
Time in seconds at the Time up and go test (TUG). Higher time means worse outcome.
Time frame: once a week fron enrollment to the end of the study (week 8)
Upper limb motricity assessed by "Fugl-Meyer Assessment of Motor Recovery after Stroke"
Motor score of upper extremity ranges from 0 (hemiplegia) to 66 points (normal motor performance). A higher score means a better outcome.
Time frame: once a week from enrollment to the end of the treatment (week 8)
Positions (on both anterior and lateral axes) of the center of pression in the exoskeleton while lateraly inclined
Measured in the exoskeleton in millimeters. Higher score indicates an asymmetric weight beiring.
Time frame: During lateropulsion program, Day 1 and Day 5 of the first week, Day 5 of the second week and Day 5 of the third week.
Patient reported discomfort experienced during exoskeleton sessions
Recorded on a visual analog scale (0-10; lower values better) and a semi-structured interview
Time frame: Once, on day 5 of the third week of the specific and intensive lateropulsion rehabilitation program including exercices in the exoskeleton
Patient reported satisfaction of exoskeleton sessions
Recorded on a visual analog scale (0-10; higher values better) and a semi-structured interview
Time frame: Once, on day 5 of the third week of the specific and intensive lateropulsion rehabilitation program including exercices in the exoskeleton
feasibility and satisfaction of the lateropulsion program perceived by physiotherapist
physiotherapist point of view, recorded with a semi structured interview and visual analog scales for feasibility and satisfaction ranging from 0 to 10, with higher scores indicating better outcomes
Time frame: Once, on day 5 of the third week of the specific and intensive lateropulsion rehabilitation program including exercices in the exoskeleton
specific effect of exoskeleton practice on positions (on both anterior and lateral axes) of the center of pression in the exoskeleton while lateraly inclined
Measured in the exoskeleton in millimeters. Higher score indicates an asymmetric weight beiring.
Time frame: During lateropulsion program, before and after a training session, on Day 1 and Day 5 of the first week, Day 5 of the second week and Day 5 of the third week.
Plan to share: Yes — 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
Supporting information: Clinical study report
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
Started Nov 2025 (actual). Primary completion is estimated for Sep 2026, 10 months after the start.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 10 months is below that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
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University Hospital, Grenoble →