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NCT Number: NCT01383512

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.

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Key information

Conditions

Subacute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Armeo spring

Device

Use of the device 1 hour per day, 5 days per week during 4 weeks

Self rehabilitation

Other

Subject have to realised alone rehabilitation exercises 1 hour per day, 5 days per week during 4 weeks.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Stroke impact scale (SIS)

    Time frame: One year

    The quality of life will be assessed through the SIS.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: REM_AVC

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jun 28, 2011
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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