Rehabilitation Robotics After a Stroke

Subacute Stroke Clinical Trial

— REM_AVC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01383512
• Other study ID #: REM_AVC
• Status: Active, not recruiting
• Phase: N/A
• First received: June 27, 2011
• Last updated: October 18, 2017
• Start date: June 2011
• Est. completion date: June 2018

Study information

• Verified date: October 2017
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 238
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Subacute Stroke

Intervention

Device:
• ARMEO Spring
Use of the device 1 hour per day, 5 days per week during 4 weeks

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

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	CRRRF	Angers
France	CHU de Bordeaux	Bordeaux
France	CHRU de Brest	Brest
France	Centre Bouffard Vercelli	Cerbere
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	CHU de Dijon	Dijon
France	CH de Garches	Garches
France	EMPR Le Normandy	Granville
France	CHU de Nîmes	Le grau du Roi
France	CHRU de Lille	Lille
France	CHU de Limoges	Limoges
France	CHU de Lyon	Lyon
France	CRF de Valmante	Marseille
France	CHU de Montpellier	Montpellier
France	IRR de Nancy	Nancy
France	CHU de Nantes	Nantes
France	APHP - Hôpital La Salpétriere	Paris
France	APHP - Hôpital Lariboisière	Paris
France	CMRRF Kerpape	Ploemeur
France	CHU de Reims	Reims
France	CHU de Rennes	Rennes
France	CHU de Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Brest	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 30
Secondary	Costs	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
Secondary	Stroke impact scale (SIS)	The quality of life will be assessed through the SIS.	One year
Secondary	Visual analog scale (VAS)	The pain of the shoulder and the upper limb will be assessed in different positions	Day 7,14,21,30, 90,180, 360
Secondary	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.	Day 30