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The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration and/or prism adaptation in patients with left hemiplegia on balance.
Imbalance is particularly severe after a Cerebral Vascular Accident because they not only limit the capacity of transfer and are a source of falls but also represent an obstacle to the acquisition of autonomy.
When the brain lesion is located in the right hemisphere, the prognosis in terms of equilibrium is worse probably because of the presence of disorders of spatial cognition. These disorders of spatial cognition are manifested by a distortion of the mental representation of space and body in space that probably cause a deviation of the position of the center of pression on platform. This component of balance disorders secondary to disruption of spatial cognition, do not benefit at present from specific rehabilitative treatment despite the severity of the consequences.
But the application of sensory manipulations has proven its effectiveness on visuospatial neglect that is another disorder of spatial cognition closed to the pathophysiology of balance disorders after right brain lesion. Sensory manipulations decrease the distortion of internal representations of the body in space by restoring the symmetry of sensory inputs. Some of these manipulations (visual manipulation by wearing prisms and proprioceptive manipulations) are also effective on the immediate correction of postural imbalances on force platform and disorders of spatial perception.
We therefore believe that the approach by repeated sensory manipulation is a new promising way of research for the rehabilitative treatment of balance disorders secondary to disorders of spatial cognition. As the mechanisms of action and the structures involved during proprioceptive vibration of neck muscles and during visual prism adaptation are different, we believe that the combination of these two types of sensory manipulations will permit to obtain a greater and longer lasting effect than a lonely manipulation. The concomitant evaluation of the bias on postural platform and the perception of the body axis will allow us to assess the impact of such rehabilitation on the disorders of spatial representation and so better understand the mechanisms of action of sensory manipulations.
The main objective of this study is to test the effectiveness of a rehabilitation program with cervical vibration (V) and / or prism adaptation (P) in patients with left hemiplegia on balance at the end of the intervention (day14).
Secondary objectives are to test:
During the 15 days rehabilitation performed for the study, the upper and lower limbs motor rehabilitation will last less than one hour and a half, and will exclude instrumental techniques of balance rehabilitation, sensory manipulations, virtual reality, strain-induced therapy.
Moreover, an ancillary study will be performed to study the immediate neurofunctional effect of vibratory stimulation, in right brain-damaged patients with imbalance and in healthy volunteers, through the assessment of cerebral activation changes in MRI. The secondary objectives of this ancillary study are to test the neurofunctional effect of repeated vibratory stimulation in right brain-damaged patients, describe the relationship between cerebral activation changes and evolution of balance, and describe the areas of the brain activated by vibratory stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | This group will benefit from conventional rehabilitation |
|
| Cervical vibration | Experimental | This group will benefit from a daily 20 minutes session, with vibration of neck muscles during 10 minutes |
|
| Prism adaptation | Experimental | This group will benefit from a daily 20 minutes session, with prism adaptation during 10 minutes |
|
| Cervical vibration + Prism adaptation | Experimental | This group will receive a daily 30 minutes session, with cervical vibration during 10 minutes + prism adaptation during 10 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical vibration | Other | Vibration of neck muscles during 10 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is the deviation of the mean position of center of pressure (CP) (eyes closed) on the mediolateral axis (mm) assessed by posturography after intervention. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of balance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time since stroke | day 0 | |
| Extent of the injury and localization of brain injury | Assessed by morphological MRI with DT1, TSE T2 and flair sequences, to achieve a morphological analysis of the lesion. The MRI will be read back by Rennes. |
Inclusion Criteria:
Right unilateral supratentorial ischemic or hemorrhagic lesion
Adult (age ≥ 18 years) under 80 years
Stroke
The first symptomatic episode
Standing balance ≥ 30 sec unaided
Percentage of weight rests on the hemiplegic lower limb below 40% of body weight (on a platform of strength)
Written informed consent of the patient or a member of his entourage (in the case of patients with motor difficulties)
Exclusion Criteria:
Inclusion Criteria for the healthy volunteers (ancillary study) :
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle BONAN, PU PH | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble | Grenoble | 38701 | France | |||
| CHU Lille |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34439582 | Result | Leplaideur S, Moulinet-Raillon A, Duche Q, Chochina L, Jamal K, Ferre JC, Bannier E, Bonan I. The Neural Bases of Egocentric Spatial Representation for Extracorporeal and Corporeal Tasks: An fMRI Study. Brain Sci. 2021 Jul 22;11(8):963. doi: 10.3390/brainsci11080963. | |
| 32245547 | Result | Jamal K, Leplaideur S, Rousseau C, Cordillet S, Raillon AM, Butet S, Cretual A, Bonan I. The effects of repetitive neck-muscle vibration on postural disturbances after a chronic stroke. Neurophysiol Clin. 2020 Sep;50(4):269-278. doi: 10.1016/j.neucli.2020.01.005. Epub 2020 Mar 31. |
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| Prism adaptation | Other | Prism adaptation during 10 minutes |
|
| Conventional rehabilitation | Other | conventional rehabilitation |
|
| Day 0, Day 14, Month 3, Month 6 |
| Evaluation of functional capacity |
| Day 0, Day 14, Month 3, Month 6 |
| Evaluation of negligence |
| Day 0, Day 14, Month 3, Month 6 |
| Understanding the mechanisms of sensory manipulations |
| Day 0, Day 14, Month 3, Month 6 |
| >2 months after hemiplegia |
| Severity of hemiplegia | motility index, Barthel | day 0 |
| Study the effect of vibratory stimulation by studying changes in brain activity in particular areas of interest involved in the representation of the body (ancillary study) | Day 0 : Functional MRI analysis for the patients included in the coordinating center (Rennes). Week 3 : Among these patients, a second functional MRI will be performed for the first 10 patients of the cervical vibration group and first 10 patients of the conventional rehabilitation group, and for 20 age and sex-matched healthy volunteers. | Day 0, Week 3 |
| Lille |
| 59000 |
| France |
| CHU Lyon | Lyon | France |
| IRF Nancy | Nancy | France |
| CHU Lariboisière-Saint Louis Paris | Paris | 75010 | France |
| Centre de Rééducation de Kerpape | Ploemeur | 56270 | France |
| CHU Reims | Reims | 51100 | France |
| CHU Rennes-Pontchaillou | Rennes | 35000 | France |
| 42392229 | Derived | Jamal K, Leplaideur S, Rousseau C, Foussat E, Painchaud S, Viallard L, Bonan I. Identifying the Factors With Later Standing Acquisition in Patients With a Right-Hemisphere Stroke: A Cross-Sectional Study Using POSTIM Data. Ann Rehabil Med. 2026 Jun;50(3):160-167. doi: 10.5535/arm.250125. Epub 2026 Jun 29. |
| 39173550 | Derived | Leplaideur S, Allart E, Chochina L, Perennou D, Rode G, Boyer FC, Paysant J, Yelnik A, Jamal K, Duche Q, Morcet JF, Laviolle B, Combes B, Bannier E, Bonan I. Neck muscle vibration and prism adaptation fail to improve balance disturbances after stroke: A multicentre randomised controlled study. Ann Phys Rehabil Med. 2024 Oct;67(7):101871. doi: 10.1016/j.rehab.2024.101871. Epub 2024 Aug 21. |