Rehabilitation Robotics After a Stroke

University Hospital, Brest238 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

238

Conditions

Subacute Stroke

Interventions

ARMEO SpringDEVICE

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

Self rehabilitationOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (23)

CHU d'Amiens

Amiens, France

CRRRF

Angers, France

Outcomes

Primary Outcomes

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

Time frame: Day 30

Secondary Outcomes

Costs

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

Stroke impact scale (SIS)

The quality of life will be assessed through the SIS.

Time frame: One year

Visual analog scale (VAS)

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

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.

Time frame: Day 30

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.