Rehabilitation Robotics After a Stroke (REM_AVC)

January 22, 2025 updated by: University Hospital, Brest

Medical and Economical Evaluation of Upper Limb's Rehabilitation Robotics After a Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80000
        • CHU d'Amiens
      • Angers, France, 49000
        • CRRRF
      • Bordeaux, France, 33073
        • CHU de Bordeaux
      • Brest, France, 29609
        • CHRU de Brest
      • Cerbere, France, 66290
        • Centre Bouffard Vercelli
      • Clermont-Ferrand, France, 63118
        • CHU de Clermont-Ferrand
      • Dijon, France, 21079
        • CHU de DIJON
      • Garches, France, 92380
        • CH de Garches
      • Granville, France, 54000
        • EMPR Le Normandy
      • Le grau du Roi, France, 30029
        • CHU de Nîmes
      • Lille, France, 59037
        • CHRU de Lille
      • Limoges, France, 87042
        • CHU de Limoges
      • Lyon, France, 69000
        • CHU de Lyon
      • Marseille, France, 13275
        • CRF de Valmante
      • Montpellier, France, 34172
        • CHU de Montpellier
      • Nancy, France, 54690
        • IRR de Nancy
      • Nantes, France, 44093
        • CHU de Nantes
      • Paris, France, 75000
        • APHP - Hôpital La Salpétriere
      • Paris, France, 75000
        • APHP - Hôpital Lariboisière
      • Ploemeur, France, 56275
        • CMRRF Kerpape
      • Reims, France, 51100
        • CHU de Reims
      • Rennes, France, 35 033
        • CHU de Rennes
      • Toulouse, France, 31059
        • CHU de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year
Stroke impact scale (SIS)
Time Frame: One year
The quality of life will be assessed through the SIS.
One year
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
Day 7,14,21,30, 90,180, 360
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.
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Olivier REMY-NERIS, Professor, University Hospital, Brest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2011

Primary Completion (Actual)

December 5, 2017

Study Completion (Actual)

December 5, 2017

Study Registration Dates

First Submitted

June 27, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimated)

June 28, 2011

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REM_AVC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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