Balance Rehabilitation With Sensory Recalibration After Stroke (AVCPOSTIM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01677091
First received: August 29, 2012
Last updated: February 24, 2014
Last verified: February 2014
  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 left hemiplegia on balance.


Condition Intervention
Left-sided Hemiplegia Affecting Dominant Side as Late Effect of Cerebrovascular Accident
Other: Cervical vibration
Other: Prism 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) (eyes closed) on the mediolateral axis (mm) assessed by posturography after intervention. [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of balance [ Time Frame: Day 0, Day 14, Month 3, Month 6 ] [ Designated as safety issue: No ]
    • Postural Assessment Scale for Stroke
    • Scale for Contraversive Pushing
    • 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 0, Day 14, Month 3, Month 6 ] [ Designated as safety issue: No ]
    • Barthel Index (Day 0, Day 14, Month 3, Month 6)
    • Number of hours of help at home (Month 3, Month 6)
    • Total Duration of hospitalization since the Cerebral Vascular Accident (Month 3, Month 6)

  • Evaluation of negligence [ Time Frame: Day 0, Day 14, Month 3, 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 0, Day 14, Month 3, Month 6 ] [ Designated as safety issue: No ]
    • Evaluation of longitudinal axis by a fluorescent bar movement in front of the patient through a computerized system.
    • Haptic Straight Ahead using a graduated table on which the subject moves his hand 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: >2 months after hemiplegia ] [ Designated as safety issue: No ]
    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.

  • 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 (ancillary study) [ Time Frame: Day 0, Week 3 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 148
Study Start Date: May 2013
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
conventional rehabilitation
Experimental: Cervical vibration
This group will benefit from a daily 20 minutes session, with vibration of neck muscles during 10 minutes
Other: Cervical vibration
Vibration of neck muscles during 10 minutes
Experimental: Prism adaptation
This group will benefit from a daily 20 minutes session, with prism adaptation during 10 minutes
Other: Prism adaptation
Prism adaptation during 10 minutes
Experimental: Cervical vibration + Prism adaptation
This group will receive a daily 30 minutes session, with cervical vibration during 10 minutes + prism adaptation during 10 minutes
Other: Cervical vibration
Vibration of neck muscles during 10 minutes
Other: Prism adaptation
Prism adaptation during 10 minutes

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Right unilateral supratentorial ischemic or hemorrhagic lesion
  • 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)

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 longitudinal axis or visual straight ahead
  • Ischemic or hemorrhagic brain stem lesion
  • Trouble for understanding protocol procedures

Inclusion Criteria for the healthy volunteers (ancillary study) :

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Grenoble, France, 38701
Contact: Dominic Perennou, PU PH         
Principal Investigator: Dominic Perennou, PU PH         
CHU Lille Recruiting
Lille, France, 59000
Contact: Marc Rousseaux, PH         
Principal Investigator: Marc Rousseaux, PH         
CHU Lyon Recruiting
Lyon, France
Contact: Gilles Rode, PU PH         
Principal Investigator: Gilles Rode, PU PH         
IRF Nancy Recruiting
Nancy, France
Contact: Pierre Paysant, PU PH         
Principal Investigator: Pierre Paysant, PU PH         
CHU Lariboisière-Saint Louis Paris Recruiting
Paris, France, 75010
Contact: Alain Yelnik, PU PH         
Principal Investigator: Alain Yelnik, PU PH         
Centre de Rééducation de Kerpape 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 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: February 24, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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 July 20, 2014