Rehabilitation Robotics After a Stroke

Not Applicable

Completed

• Conditions: Subacute Stroke
• Interventions: Device: ARMEO Spring; Other: Self rehabilitation

• Registration Number: NCT01383512
• Lead Sponsor: University Hospital, Brest

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Primary Completion: 2017-12-05
• Study Completion: 2017-12-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteer	ARMEO Spring	20 healthy volunteer will be recruiting and using ARMEO Spring. All volunteer will repeat 5 times the same program on the medical device.
Rehabilitation robotics	ARMEO Spring	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.
Self-rehabilitation	Self rehabilitation	Subject will associated to there classical care 1 hours, 5 days per week during 4 weeks, of self rehabilitation.

Primary Outcome Measures

Name	Time	Method
Fugl Meyer upper limb motor score	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

Name	Time	Method
Stroke impact scale (SIS)	One year	The quality of life will be assessed through the SIS.
Visual analog scale (VAS)	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	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.
Costs	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.

Trial Locations

Locations (23)

CRRRF; 🇫🇷 Angers, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

Centre Bouffard Vercelli; 🇫🇷 Cerbere, France

CHU de Dijon; 🇫🇷 Dijon, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, 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

IRR de Nancy; 🇫🇷 Nancy, France

CHU de Nantes; 🇫🇷 Nantes, France

APHP - Hôpital Lariboisière; 🇫🇷 Paris, France

CMRRF Kerpape; 🇫🇷 Ploemeur, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Toulouse; 🇫🇷 Toulouse, France

CHU d'Amiens; 🇫🇷 Amiens, France

CHRU de Brest; 🇫🇷 Brest, France

APHP - Hôpital La Salpétriere; 🇫🇷 Paris, France

CHU de Montpellier; 🇫🇷 Montpellier, France

CHU de Reims; 🇫🇷 Reims, France