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Balance Rehabilitation With Sensory Recalibration After Stroke (AVCPOSTIM)

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ClinicalTrials.gov Identifier: NCT01677091
Recruitment Status : Recruiting
First Posted : August 31, 2012
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Left-sided Hemiplegia Affecting Dominant Side as Late Effect of Cerebrovascular Accident Other: Cervical vibration Other: Prism adaptation Other: Conventional rehabilitation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Balance Rehabilitation Program With Sensory Recalibration After Stroke: A Randomized Controlled Trial.
Actual Study Start Date : May 5, 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Evaluation of balance [ Time Frame: Day 0, Day 14, Month 3, Month 6 ]
    • 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.

  2. Evaluation of functional capacity [ Time Frame: Day 0, Day 14, Month 3, Month 6 ]
    • 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)

  3. Evaluation of negligence [ Time Frame: Day 0, Day 14, Month 3, Month 6 ]
    • Bell test,
    • Bisection test,
    • Scale of Catherine Bergego,
    • OTA test
    • Test of bodily neglect.

  4. Understanding the mechanisms of sensory manipulations [ Time Frame: Day 0, Day 14, Month 3, Month 6 ]
    • 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:
  1. Time since stroke [ Time Frame: day 0 ]
  2. Extent of the injury and localization of brain injury [ Time Frame: >2 months after hemiplegia ]
    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.

  3. Severity of hemiplegia [ Time Frame: day 0 ]
    motility index, Barthel

  4. 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 ]

    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.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677091


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

Locations
France
CHU Grenoble Completed
Grenoble, France, 38701
CHU Lille Completed
Lille, France, 59000
CHU Lyon Completed
Lyon, France
IRF Nancy Completed
Nancy, France
CHU Lariboisière-Saint Louis Paris Terminated
Paris, France, 75010
Centre de Rééducation de Kerpape Completed
Ploemeur, France, 56270
CHU Reims Completed
Reims, France, 51100
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

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01677091     History of Changes
Other Study ID Numbers: 2012-A00667-36
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

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

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