Balance Rehabilitation With Sensory Recalibration After Stroke (AVCPOSTIM)

This study is not yet open for participant recruitment.
Verified August 2012 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01677091
First received: August 29, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

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 hemiplegia on balance in patients with a right cerebral lesion.


Condition Intervention
Left-sided Hemiplegia Affecting Dominant Side as Late Effect of Cerebrovascular Accident
Other: Cervical vibration
Other: Prisms adaptation
Other: conventional rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Balance Rehabilitation Program With Sensory Recalibration After Stroke: A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • The primary outcome is the deviation of the mean position of center of pressure (CP) on the mediolateral axis (mm) assessed by posturography after intervention. [ Time Frame: day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the balance [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    • Postural Assessment Scale
    • Berg Balance Scale
    • Timed Up and Go
    • Measurement performed on the platform of strength:

      • surface of the center of mass displacement
      • deviation of the mean position of the center pressure on the anteroposterior axis
      • standard deviation of the average displacement of the center pressure on the mediolateral axis and the anteroposterior axis,
      • percentage of support on the hemiplegic lower limb.

  • Evaluation of the balance [ Time Frame: month 3 ] [ Designated as safety issue: No ]
    • Postural Assessment Scale
    • Berg Balance Scale
    • Timed Up and Go
    • Measurement performed on the platform of strength:

      • surface of the center of mass displacement
      • deviation of the mean position of the center pressure on the anteroposterior axis
      • standard deviation of the average displacement of the center pressure on the mediolateral axis and the anteroposterior axis,
      • percentage of support on the hemiplegic lower limb.

  • Evaluation of the balance [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    • Postural Assessment Scale for
    • Berg Balance Scale
    • Timed Up and Go
    • Measurement performed on the platform of strength:

      • surface of the center of mass displacement
      • deviation of the mean position of the center pressure on the anteroposterior axis
      • standard deviation of the average displacement of the center pressure on the mediolateral axis and the anteroposterior axis,
      • percentage of support on the hemiplegic lower limb.

  • Evaluation of functional capacity [ Time Frame: day 14 ] [ Designated as safety issue: No ]
    • Barthel Index.
    • Number of hours of help at home
    • Total Duration of hospitalization since the Cerebral Vascular Accident

  • Evaluation of functional capacity [ Time Frame: month 3 ] [ Designated as safety issue: No ]
    • Barthel Index.
    • Number of hours of help at home
    • Total Duration of hospitalization since the Cerebral Vascular Accident

  • Evaluation of functional capacity [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    • Barthel Index.
    • Number of hours of help at home
    • Total Duration of hospitalization since the Cerebral Vascular Accident

  • Evaluation of negligence [ Time Frame: day 14 ] [ Designated as safety issue: No ]
    • bell test,
    • Bisection test,
    • scale of Catherine Bergego,
    • OTA test
    • test of bodily neglect.

  • Evaluation of negligence [ Time Frame: month 3 ] [ Designated as safety issue: No ]
    • bell test,
    • Bisection test,
    • scale of Catherine Bergego,
    • OTA test
    • test of bodily neglect.

  • Evaluation of negligence [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    • bell test,
    • Bisection test,
    • scale of Catherine Bergego,
    • OTA test
    • test of bodily neglect.

  • Understanding the mechanisms of sensory manipulations [ Time Frame: day 14 ] [ Designated as safety issue: No ]
    • Measurement of spontaneous trunk inclination (by optoelectronic system)
    • start sitting when the subject is on the platform
    • Visual Vertical (by projecting a fluorescent bar in front of the patient through a computerized system).
    • haptic Straight Ahead (using a graduated table on which the subject moves his index blindfolded.

  • Understanding the mechanisms of sensory manipulations [ Time Frame: month 3 ] [ Designated as safety issue: No ]
    • Measurement of spontaneous trunk inclination (by optoelectronic system)
    • start sitting when the subject is on the platform
    • Visual Vertical (by projecting a fluorescent bar in front of the patient through a computerized system).
    • haptic Straight Ahead (using a graduated table on which the subject moves his index blindfolded.

  • Understanding the mechanisms of sensory manipulations [ Time Frame: month 6 ] [ Designated as safety issue: No ]
    • Measurement of spontaneous trunk inclination (by optoelectronic system)
    • start sitting when the subject is on the platform
    • Visual Vertical (by projecting a fluorescent bar in front of the patient through a computerized system).
    • haptic Straight Ahead (using a graduated table on which the subject moves his index blindfolded.


Other Outcome Measures:
  • Time since stroke [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  • Extent of the injury and localization of brain injury [ Time Frame: month 2 ] [ Designated as safety issue: No ]
    by morphological MRI with sequences DT1, TSE T2 and flair to achieve a morphological analysis of the lesion. The MRI will be read back by central Rennes.

  • Presence of negligence [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    battery of five tests

  • Severity of hemiplegia [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    motility index, Barthel

  • study the effect of vibratory stimulation by studying changes in brain activity in particular areas of interest involved in the representation of the body [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    functional MRI analysis in patients included in the coordinating centre

  • study the effect of vibratory stimulation by studying changes in brain activity in particular areas of interest involved in the representation of the body [ Time Frame: day 14 ] [ Designated as safety issue: No ]
    functional MRI analysis in patients included in the coordinating centre


Estimated Enrollment: 148
Study Start Date: October 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: control group
This group will benefit from conventional rehabilitation
Other: conventional rehabilitation
This group will benefit from conventional rehabilitation
Experimental: cervical vibration
This group will benefit from a session of 20 minutes of vibration of neck muscles daily
Other: Cervical vibration
This group will benefit from a session of 20 minutes of vibration of neck muscles daily
Experimental: prisms adaptation
This group will benefit from a session of 20 minutes per day of prism adaptation
Other: Prisms adaptation
This group will benefit from a session of 20 minutes per day of prism adaptation
Experimental: Cervical vibration + Prisms adaptation
This group will receive a 20 minutes session vibration + 1 session of 20 minutes per day prisms
Other: Cervical vibration
This group will benefit from a session of 20 minutes of vibration of neck muscles daily
Other: Prisms adaptation
This group will benefit from a session of 20 minutes per day of prism adaptation

Detailed Description:

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:

  • 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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic or hemorrhagic lesion of the territory of the right middle cerebral artery
  • 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
  • Balance ≥ 30 sec standing 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:

  • Orthopedic, rheumatologic or visual disorders affecting the distribution of the center of pressure while standing
  • Visual disorder that does not allow assessment of the visual vertical or straight ahead vision
  • Ischemic or hemorrhagic cerebral lesion of the anterior or posterior artery
  • ischemic or hemorrhagic brain stem lesion
  • Trouble for understanding protocol procedures
  • Contraindication to MRI
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677091

Contacts
Contact: Isabelle BONAN, PU PH +33-2-99-28-96-17 isabelle.bonan@chu-rennes.fr

Locations
France
CHU Grenoble Not yet recruiting
Grenoble, France, 38701
Contact: Dominic Perennou, PU PH            
Principal Investigator: Dominic Perennou, PU PH            
CHU Lille Not yet recruiting
Lille, France, 59000
Contact: Marc Rousseaux, PH            
Principal Investigator: Marc Rousseaux, PH            
CHU Lyon Not yet recruiting
Lyon, France
Contact: Gilles Rode, PU PH            
Principal Investigator: Gilles Rode, PU PH            
IRF Nancy
Nancy, France
CHU Lariboisière-Saint Louis Paris Not yet recruiting
Paris, France, 75010
Contact: Alain Yelnik, PU PH            
Principal Investigator: Alain Yelnik, PU PH            
Centre de Rééducation de Kerpape Not yet recruiting
Ploemeur, France, 56270
Contact: Stéphanie Leplaideur, PH            
Principal Investigator: Stéphanie Leplaideur, PH            
CHU Reims Not yet recruiting
Reims, France, 51100
Contact: Francois Boyer, PU PH            
Principal Investigator: Francois Boyer, PU PH            
CHU Rennes-Pontchaillou Not yet recruiting
Rennes, France, 35000
Contact: Isabelle BONAN, PU PH            
Principal Investigator: Isabelle BONAN, PU PH            
Sub-Investigator: Gilles EDAN, PU PH            
Sub-Investigator: Jean Yves Gauvrit, PU PH            
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Isabelle BONAN, PU PH Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01677091     History of Changes
Other Study ID Numbers: 2012-A00667-36
Study First Received: August 29, 2012
Last Updated: August 29, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
Balance,Hemiplegia,Cervical vibration,Prism adaptation,Rehabilitation

Additional relevant MeSH terms:
Hemiplegia
Cerebral Infarction
Stroke
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013