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Rehabilitation Robotics After a Stroke (REM_AVC)

Primary Purpose

Subacute Stroke

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ARMEO Spring
Self rehabilitation
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacute Stroke focused on measuring stroke, rehabilitation, robotics, motor control, upper limb

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU d'Amiens
  • CRRRF
  • CHU de Bordeaux
  • CHRU de Brest
  • Centre Bouffard Vercelli
  • CHU de Clermont-Ferrand
  • CHU de Dijon
  • CH de Garches
  • EMPR Le Normandy
  • CHU de Nîmes
  • CHRU de Lille
  • CHU de Limoges
  • CHU de Lyon
  • CRF de Valmante
  • CHU de Montpellier
  • IRR de Nancy
  • CHU de Nantes
  • APHP - Hôpital La Salpétriere
  • APHP - Hôpital Lariboisière
  • CMRRF Kerpape
  • CHU de Reims
  • CHU de Rennes
  • CHU de Toulouse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Rehabilitation robotics

Self-rehabilitation

Healthy volunteer

Arm Description

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.

Subject will associated to there classical care 1 hours, 5 days per week during 4 weeks, of self rehabilitation.

20 healthy volunteer will be recruiting and using ARMEO Spring. All volunteer will repeat 5 times the same program on the medical device.

Outcomes

Primary Outcome Measures

Fugl Meyer upper limb motor score
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
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)
The quality of life will be assessed through the SIS.
Visual analog scale (VAS)
The pain of the shoulder and the upper limb will be assessed in different positions
Modification of motor control
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.

Full Information

First Posted
June 27, 2011
Last Updated
October 18, 2017
Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01383512
Brief Title
Rehabilitation Robotics After a Stroke
Acronym
REM_AVC
Official Title
Medical and Economical Evaluation of Upper Limb's Rehabilitation Robotics After a Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (Actual)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacute Stroke
Keywords
stroke, rehabilitation, robotics, motor control, upper limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
238 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation robotics
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-rehabilitation
Arm Type
Active Comparator
Arm Description
Subject will associated to there classical care 1 hours, 5 days per week during 4 weeks, of self rehabilitation.
Arm Title
Healthy volunteer
Arm Type
Other
Arm Description
20 healthy volunteer will be recruiting and using ARMEO Spring. All volunteer will repeat 5 times the same program on the medical device.
Intervention Type
Device
Intervention Name(s)
ARMEO Spring
Intervention Description
Use of the device 1 hour per day, 5 days per week during 4 weeks
Intervention Type
Other
Intervention Name(s)
Self rehabilitation
Intervention Description
Subject have to realised alone rehabilitation exercises 1 hour per day, 5 days per week during 4 weeks.
Primary Outcome Measure Information:
Title
Fugl Meyer upper limb motor score
Description
Increase of the Fugl Meyer score between day 0 and day 30 with a difference between groups by at least 4 points
Time Frame
Day 30
Secondary Outcome Measure Information:
Title
Costs
Description
The rehabilitation costs will be assessed for each group through medical and physiotherapist consultations, hospitalization costs, day of return to work if concerned.
Time Frame
One year
Title
Stroke impact scale (SIS)
Description
The quality of life will be assessed through the SIS.
Time Frame
One year
Title
Visual analog scale (VAS)
Description
The pain of the shoulder and the upper limb will be assessed in different positions
Time Frame
Day 7,14,21,30, 90,180, 360
Title
Modification of motor control
Description
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.
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier REMY-NERIS, Professor
Organizational Affiliation
University Hospital, Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU d'Amiens
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
CRRRF
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33073
Country
France
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Centre Bouffard Vercelli
City
Cerbere
ZIP/Postal Code
66290
Country
France
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63118
Country
France
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CH de Garches
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
EMPR Le Normandy
City
Granville
ZIP/Postal Code
54000
Country
France
Facility Name
CHU de Nîmes
City
Le grau du Roi
ZIP/Postal Code
30029
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHU de Lyon
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
CRF de Valmante
City
Marseille
ZIP/Postal Code
13275
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34172
Country
France
Facility Name
IRR de Nancy
City
Nancy
ZIP/Postal Code
54690
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
APHP - Hôpital La Salpétriere
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
APHP - Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
CMRRF Kerpape
City
Ploemeur
ZIP/Postal Code
56275
Country
France
Facility Name
CHU de Reims
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35 033
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33910364
Citation
Remy-Neris O, Le Jeannic A, Dion A, Medee B, Nowak E, Poiroux E, Durand-Zaleski I; REM Investigative Team*. Additional, Mechanized Upper Limb Self-Rehabilitation in Patients With Subacute Stroke: The REM-AVC Randomized Trial. Stroke. 2021 Jun;52(6):1938-1947. doi: 10.1161/STROKEAHA.120.032545. Epub 2021 Apr 29.
Results Reference
derived

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Rehabilitation Robotics After a Stroke

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