An interventional study of Robot Group and Traditional physiotherapy in Stroke, sponsored by IRCCS San Raffaele Roma. Terminated at 2 sites in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-10-03.
Sponsored by IRCCS San Raffaele Roma · Not applicable, Interventional, and Treatment
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.
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:
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →IRCCS San Raffaele Roma is the lead sponsor of 63 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each subject will receive 4 weeks of traditional upper limb rehabilitation treatment (20 sessions, 5 days a week for 4 weeks).
Procedure: Traditional physiotherapy
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).
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.
Also known as: MIT-MANUS/InMotion2
Active or passive exercises.
Also known as: FKT
Change from Baseline in Fugl-Meyer Scale at 28 weeks.
Time frame: at inclusion, week 4 and week 28
Change from Baseline in Box and Block Test at 28 weeks.
Time frame: at inclusion, week 4 and week 28.
Change from Baseline in Modified Ashworth Scale at 28 weeks.
Time frame: at inclusion, week 4 and week 28.
Change from Baseline in Frenchay Arm Test at 28 weeks.
Time frame: at inclusion, week 4 and week 28.
This study is terminated, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele Roma