Balance Rehabilitation With Sensory Recalibration After Stroke
NCT ID: NCT01677091
Last Updated: 2023-05-24
Study Results
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Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2013-05-05
2019-10-14
Brief Summary
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Detailed Description
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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:
* The immediate effect (day 0) on force platform evaluation of balance,
* Maintaining the gain at 3 months and 6 months on balance,
* Effectiveness at day 14 on negligence
* Maintaining the gain at 3 months and 6 months on neglect,
* Effectiveness at day 14 on functional abilities,
* Maintaining the gain at 3 months and 6 months on functional abilities,
* Understanding the mechanisms of action of each of the sensory manipulations by assessing changes in perceptions of space, after rehabilitation programs (day 14) and at 3 months and 6 months.
* To evaluate the evolution of motility, sensitivity and spasticity in the various assessments.
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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Control group
This group will benefit from conventional rehabilitation
Conventional rehabilitation
conventional rehabilitation
Cervical vibration
This group will benefit from a daily 20 minutes session, with vibration of neck muscles during 10 minutes
Cervical vibration
Vibration of neck muscles during 10 minutes
Prism adaptation
This group will benefit from a daily 20 minutes session, with prism adaptation during 10 minutes
Prism adaptation
Prism adaptation during 10 minutes
Cervical vibration + Prism adaptation
This group will receive a daily 30 minutes session, with cervical vibration during 10 minutes + prism adaptation during 10 minutes
Cervical vibration
Vibration of neck muscles during 10 minutes
Prism adaptation
Prism adaptation during 10 minutes
Interventions
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Cervical vibration
Vibration of neck muscles during 10 minutes
Prism adaptation
Prism adaptation during 10 minutes
Conventional rehabilitation
conventional rehabilitation
Eligibility Criteria
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Inclusion Criteria
* Adult (age ≥ 18 years) under 80 years
* Stroke
* older than 9 months
* with or without hemianopsia
* with or without visuospatial hemineglect
* 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)
* Age ≥ 18 years, right-handed, sex and age-matched (+/- 5 years) to the patients of the coordinating center
* Able to get an MRI
* With no imbalance
* With no visual disorder impacting the repartition of the center of pression when standing up, or that does not allow assessment of the longitudinal axis or visual straight ahead
* Written informed consent
Exclusion Criteria
* Visual disorder that does not allow assessment of the longitudinal axis or visual straight ahead
* Ischemic or hemorrhagic brain stem lesion
* Trouble for understanding protocol procedures
18 Years
80 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Isabelle BONAN, PU PH
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
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CHU Grenoble
Grenoble, , France
CHU Lille
Lille, , France
CHU Lyon
Lyon, , France
IRF Nancy
Nancy, , France
CHU Lariboisière-Saint Louis Paris
Paris, , France
Centre de Rééducation de Kerpape
Ploemeur, , France
CHU Reims
Reims, , France
CHU Rennes-Pontchaillou
Rennes, , France
Countries
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References
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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.
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.
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.
Other Identifiers
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2012-A00667-36
Identifier Type: -
Identifier Source: org_study_id
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