Robot-aided Therapy in Stroke Patients for Upper Limb Rehabilitation (MITEEG)

IRCCS San Raffaele Roma

Status: Terminated

Conditions: Stroke

Treatments: Device: Robot Group; Procedure: Traditional physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01658111

MIT02012EEG

Details and patient eligibility

About

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.

Full description

The main original contribution of this project is to provide an experimental framework, based on proximal robotic treatment approach, to test whether starting with the distal robot-assisted sensorimotor therapy the effective in improving motor functions of sub-acute stroke patients.

The use of robotic platforms to administer the rehabilitation therapy is crucial for two main reasons:

1. the physical therapies based on robotic platforms assure that each patient in the same testing group is treated in the same repeatable way, eliminating the intrinsic subject-dependent variability that affects traditional therapies;
2. the robotic platforms, in conjunction with EEG and EMG recordings, can be used to assess the effects of the rehabilitative treatments in a quantitative, measurable way, by providing reliable and objective methods for measuring functional recovery after stroke.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• first acute event of cerebrovascular stroke
• unilateral paresis,
• ability to understand and follow simple instructions,
• ability to remain in a sitting posture, even through seat belts for trunk fixation.

Exclusion criteria

• bilateral impairment,
• severe sensory deficits in the paretic upper limb,
• cognitive impairment or behavioral dysfunction that would influence the ability to comprehend or perform the experiment,
• refusal or inability to provide informed consent
• other current severe medical problems.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Traditional physiotherapy

Active Comparator group

Description:

Each subject will receive 4 weeks of traditional upper limb rehabilitation treatment (20 sessions, 5 days a week for 4 weeks).

Treatment:

Procedure: Traditional physiotherapy

Robot Group

Experimental group

Description:

Each subject will be asked to perform five sessions per week goal-directed, planar reaching tasks, which emphasizes shoulder and elbow movements, moving from the centre target to each of 8 peripheral targets equally spaced on a 0.14 m radius circumference around a centre target using the InMotion2 (IM2) system (20 sessions- 5 days a week for 4 weeks).

Treatment:

Device: Robot Group