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Rehabilitation Robotics After a Stroke (REM_AVC)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01383512
First Posted: June 28, 2011
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
  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
Subacute Stroke Device: ARMEO Spring Other: Self rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 ]
    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 ]
    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 ]
    The quality of life will be assessed through the SIS.

  • Visual analog scale (VAS) [ Time Frame: Day 7,14,21,30, 90,180, 360 ]
    The pain of the shoulder and the upper limb will be assessed in different positions

  • Modification of motor control [ Time Frame: Day 30 ]
    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.


Enrollment: 238
Actual Study Start Date: June 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01383512


Locations
France
CHU d'Amiens
Amiens, France, 80000
CRRRF
Angers, France, 49000
CHU de Bordeaux
Bordeaux, France, 33073
CHRU de Brest
Brest, France, 29609
Centre Bouffard Vercelli
Cerbere, France, 66290
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63118
CHU de Dijon
Dijon, France, 21079
CH de Garches
Garches, France, 92380
EMPR Le Normandy
Granville, France, 54000
CHU de Nîmes
Le grau du Roi, France, 30029
CHRU de Lille
Lille, France, 59037
CHU de Limoges
Limoges, France, 87042
CHU de Lyon
Lyon, France, 69000
CRF de Valmante
Marseille, France, 13275
CHU de Montpellier
Montpellier, France, 34172
IRR de Nancy
Nancy, France, 54690
CHU de Nantes
Nantes, France, 44093
APHP - Hôpital La Salpétriere
Paris, France, 75000
APHP - Hôpital Lariboisière
Paris, France, 75000
CMRRF Kerpape
Ploemeur, France, 56275
CHU de Reims
Reims, France, 51100
CHU de Rennes
Rennes, France, 35 033
CHU de Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
Investigators
Principal Investigator: Olivier REMY-NERIS, Professor University Hospital, Brest
  More Information

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01383512     History of Changes
Other Study ID Numbers: REM_AVC
First Submitted: June 27, 2011
First Posted: June 28, 2011
Last Update Posted: October 19, 2017
Last Verified: October 2017

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

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