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Rehabilitation Robotics After a Stroke (REM_AVC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital, Brest
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01383512
First received: June 27, 2011
Last updated: September 1, 2014
Last verified: September 2014
  Purpose

Upper limb motor control after a stroke may be improved with rehabilitation robotics at a subacute stage. The aim of this multicenter controled randomized single blind study is to define the place of rehabilitation robotics at this phase of the rehabilitation process. Both groups will realize the same time of rehabilitation. The cost benefit ratio will be compared in each group through medical assessment of improvement and definition of the costs due to the rehabilitation process.


Condition Intervention Phase
Subacute Stroke
Device: ARMEO Spring
Other: Self rehabilitation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Medical and Economical Evaluation of Upper Limb's Rehabilitation Robotics After a Stroke

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • Fugl Meyer upper limb motor score [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Increase of the Fugl Meyer score between day 0 and day 30 with a difference between groups by at least 4 points


Secondary Outcome Measures:
  • Costs [ Time Frame: One year ] [ Designated as safety issue: No ]
    The rehabilitation costs will be assessed for each group through medical and physiotherapist consultations, hospitalization costs, day of return to work if concerned.

  • Stroke impact scale (SIS) [ Time Frame: One year ] [ Designated as safety issue: No ]
    The quality of life will be assessed through the SIS.

  • Visual analog scale (VAS) [ Time Frame: Day 7,14,21,30, 90,180, 360 ] [ Designated as safety issue: No ]
    The pain of the shoulder and the upper limb will be assessed in different positions

  • Modification of motor control [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Parameter and result of rehabilitation program on ARMEO spring are saved. Data of patient in rehabilitation robotics and healthy volunteer arms will be compared in order to evaluate the modification of the motor control at Day 30.


Estimated Enrollment: 240
Study Start Date: June 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rehabilitation robotics
Subjects will be practicing an Armeo Spring rehabilitation program in addition to their usual care (1.5h/day,5d/week) 1h/day 5d/week 4 weeks.
Device: ARMEO Spring
Use of the device 1 hour per day, 5 days per week during 4 weeks
Active Comparator: Self-rehabilitation
Subject will associated to there classical care 1 hours, 5 days per week during 4 weeks, of self rehabilitation.
Other: Self rehabilitation
Subject have to realised alone rehabilitation exercises 1 hour per day, 5 days per week during 4 weeks.
Healthy volunteer
20 healthy volunteer will be recruiting and using ARMEO Spring. All volunteer will repeat 5 times the same program on the medical device.
Device: ARMEO Spring
Use of the device 1 hour per day, 5 days per week during 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke of the middle cerebral arteria territory
  • 18 to 80 years old
  • stroke onset between 3 weeks to 3 months,with or without aphasia, with or without lateral neglect and homonymous hemianopia, with or without visual neglect
  • 10<or= Fugl Meyer upper limb Score <or= 40
  • upper limbs pain less or equal than 3/10 (VAS)
  • inpatient or outpatient rehabilitation
  • signed inform consent

Exclusion Criteria:

  • ischemic or hemorrhagic stroke of anterior or posterior cerebral artery
  • ischemic or hemorrhagic stroke of the brainstem
  • major aphasia evaluated by a Boston Diagnostic Aphasia Examination (BDAE) score less or equal to 3
  • asthenia not allowing to work 60 minutes with the robot.
  • serious visual deficiency not allowing to use the robot
  • impossibility to install the arm on the robot because of a serious and uncontrolled spasticity or for any other reason
  • pronounced and constant muscular contractures, or deformation affecting the use of the extremity
  • upper limb's pain superior to 3/10 and/or being worse at the active and passive mobilization
  • serious infection and/or instability of vital functions
  • perfusion of the affected upper limb not removable
  • incapacity to stay on a chair
  • contraindicated sitting position
  • permanent deviation of the head and\or of the eyes
  • perturbed or non-cooperative patient
  • patients that must have to be isolated due to an infection process
  • bone fracture of the paretic limb with an onset less than 3 months stabilized or not
  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: NCT01383512

Contacts
Contact: Olivier REMY-NERIS 0033 2 98 22 31 52

Locations
France
CHU d'Amiens Not yet recruiting
Amiens, France, 80000
Contact: Sophie TASSEEL-PONCHE, Dr         
Principal Investigator: Sophie TASSEEL-PONCHE, Dr         
CRRRF Recruiting
Angers, France, 49000
Contact: Anne-Laure FERRAPIE    0033 2 41 35 17 09      
Principal Investigator: Anne-Laure FERRAPIE         
Sub-Investigator: Isabelle RICHARD         
CHU de Bordeaux Recruiting
Bordeaux, France, 33073
Contact: Patrick DEHAIL    0033 5 56 79 55 46      
Principal Investigator: Patrick DEHAIL         
Sub-Investigator: Claire DELLECI         
CHRU de Brest Recruiting
Brest, France, 29609
Contact: Olivier REMY-NERIS    0033 2 98 22 31 52      
Principal Investigator: Olivier REMY-NERIS         
Sub-Investigator: Béatrice MEDEE         
Centre Bouffard Vercelli Recruiting
Cerbere, France, 66290
Contact: Michel ENJALBERT    0033 4 68 88 75 00      
Principal Investigator: Michel ENJALBERT         
Sub-Investigator: Catherine LEBLOND         
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63118
Contact: Emmanuel COUDEYRE    0033 4 73 75 09 00      
Principal Investigator: Emmanuel COUDEYRE         
Sub-Investigator: Isabelle RELAVE         
CHU de Dijon Recruiting
Dijon, France, 21079
Contact: Charles BENAIM    0033 3 80 29 33 71      
Principal Investigator: Charles BENAIM         
CH de Garches Recruiting
Garches, France, 92380
Contact: Djamel BENSMAIL    0033 1 47 10 70 60      
Principal Investigator: Djamel BENSMAIL         
EMPR Le Normandy Recruiting
Granville, France, 54000
Contact: Jean-Luc ISAMBERT    0033 2 33 90 33 08      
Principal Investigator: Jean-Luc ISAMBERT         
CHU de Nîmes Recruiting
Le grau du Roi, France, 30029
Contact: Jacques PELISSIER    0033 4 66 02 25 36      
Principal Investigator: Jacques PELISSIER         
Sub-Investigator: Jérome FROGER         
Sub-Investigator: Huei Yune BONNIN         
CHRU de Lille Recruiting
Lille, France, 59037
Contact: Marc ROUSSEAUX    0033 3 20 44 48 71      
Principal Investigator: Marc ROUSSEAUX         
Sub-Investigator: Walter DAVELUY         
CHU de Limoges Recruiting
Limoges, France, 87042
Contact: Jean-Christophe DAVIET    0033 5 55 05 65 18      
Principal Investigator: Jean-Christophe DAVIET         
Sub-Investigator: Romain JOSTE         
CHU de Lyon Recruiting
Lyon, France, 69000
Contact: Dominique BOISSON    0033 4 78 86 50 21      
Principal Investigator: Dominique BOISSON         
Sub-Investigator: Soline BELLAICHE         
CRF de Valmante Recruiting
Marseille, France, 13275
Contact: Djawad ABBAS, MD         
CHU de Montpellier Completed
Montpellier, France, 34172
IRR de Nancy Recruiting
Nancy, France, 54690
Contact: Jean-Marie BEIS    0033 3 83 22 22 31      
Principal Investigator: Jean-Marie BEIS         
Sub-Investigator: Hélène GUESDON         
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Angélique STEFAN    0033 2 40 84 60 47      
Principal Investigator: Angélique STEFAN         
APHP - Hôpital La Salpétriere Completed
Paris, France, 75000
APHP - Hôpital Lariboisière Recruiting
Paris, France, 75000
Contact: Alain YELNIK    0033 1 40 05 42 05      
Principal Investigator: Alain YELNIK         
Sub-Investigator: Nacera BRADAI         
CMRRF Kerpape Recruiting
Ploemeur, France, 56275
Contact: Jacques KERDRAON    0033 2 97 82 60 40      
Principal Investigator: Jacques KERDRAON         
Sub-Investigator: Pauline COIGNARD         
CHU de Reims Recruiting
Reims, France, 51100
Contact: Francois BOYER    0033 3 26 78 85 97      
Principal Investigator: François BOYER         
Sub-Investigator: Laetitia PERCEBOIS-MACADRE         
CHU de Rennes Recruiting
Rennes, France, 35 033
Contact: Isabelle BONAN    0033 2 99 28 42 18      
Principal Investigator: Isabelle BONAN         
CHU de St Etienne Withdrawn
Saint Etienne, France, 42055
CHU de Toulouse Recruiting
Toulouse, France, 31059
Contact: Philippe MARQUE    0033 5 61 32 28 01      
Principal Investigator: Philippe MARQUE         
Sub-Investigator: Xavier DE BOISSEZON         
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
Investigators
Principal Investigator: Olivier REMY-NERIS, Professor University Hospital, Brest
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01383512     History of Changes
Other Study ID Numbers: REM_AVC
Study First Received: June 27, 2011
Last Updated: September 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
stroke
rehabilitation
robotics
motor control
upper limb

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014