Robot-aided Therapy in Stroke Patients for Upper Limb Rehabilitation

Summary

Numerous studies showed that ascertaining the effectiveness of rehabilitative interventions on conditions leading to long-term disability, such as stroke, is a complex task because the outcome depends on many interacting factors. Several studies underline the importance of brain plasticity and its therapeutic potential in neurological disorders. Accredited theories of cortical reorganization after brain lesion endorse the use of early, intensive, repetitive, and context-related exercise as optimal strategies to promote motor relearning and minimize motor deficit. The use of robotic systems in upper limb motor rehabilitation programs has been already demonstrated to provide safe and intensive treatment to subjects with motor impairments due to a neurological injury: several studies showed the advantages of robotic therapy on chronic post-stroke patients, even if no consistent influence on functional abilities was found and evidence of better results providing intensive treatments, both robotic and conventional rehabilitative techniques, was found. Recent development and recent trial in robot-assisted rehabilitation has shown the great potential of robotic devices for delivering repetitive training, thus facilitating a high intensity and a large dose of training during sub-acute and chronic phases of stroke rehabilitation. The proposed project, through a randomized controlled observer-blind multicenter trial is aimed at evaluating the effectiveness of robot-assisted therapy as additional treatment to the standard physical therapy in the early phase after stroke onset and evaluating in conjunction with EEG and EMG recordings the effects of the rehabilitative treatments in a quantitative, measurable way, by providing reliable and objective methods for measuring functional recovery after stroke.

Conditions

• Stroke

Interventions

DEVICE

Robot Group

The MIT-MANUS/InMotion2 (Interactive Motion Technologies, Inc., Watertown, MA, USA) system has two translational degrees of freedom (dof): shoulder abduction-adduction (ab-ad), elbow flexion-extension (flexext). The robotic system supports the execution of reaching movements in the horizontal plane through an assist as needed control strategy. The robot can guide the movement of the upper limb of the patients and record end-effector physical quantities such as the position, velocity, and applied forces. The device is designed to have a low intrinsic end-point impedance (i.e., be back-drivable to easily carry the weight of the patient's arm, to execute movements without constraint and offer minimal resistance. A 3-dof force transducer is placed at the robots end-effector, as well.

PROCEDURE

Traditional physiotherapy

Active or passive exercises.

Sponsors & Collaborators

• IRCCS San Raffaele Roma

  lead OTHER

Principal Investigators

• Michela Goffredo, BME · IRCCS San Raffaele Rome

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2013-07-31

Completion

2014-08-31

Countries

• Italy

Study Locations