Clinical Trial: Action Observation Treatment (AOT) as a Rehabilitation Tool

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Study on the Effectiveness of Action Observation Treatment (AOT) as a Rehabilitation Tool in Acute Stroke Patients and in Chronic Stroke Patients With Apraxia: a Randomized Controlled Trial

Brief Summary: Epidemiological studies report that 85% of stroke survivors show hemiparesis and a percentage ranging from 55% to 75% report upper limb functional impairment. Early rehabilitation in stroke patients with motor disorders can be effective to restore the affected function and to improve the performance of daily activities. Up to now, different methods and techniques have been used to recover motor functions in stroke patients. However, none of these has been conclusively proven to be more effective than the others. The clinical benefits induced by motor rehabilitation are closely related to "neuroplasticity". The main aim of the present study is to assess the efficacy of action observation treatment, based on Mirror Neuron System (MNS), in the rehabilitation of upper limb motor functions in acute stroke patients. The study will also aim at assessing neuroplasticity within areas belonging to the MNS through functional magnetic resonance (fMRI).

Detailed Summary:

  1. Study Rationale: Epidemiological studies report that 85% of stroke survivors show hemiparesis and a percentage ranging from 55% to 75% report upper limb functional impairment. Early rehabilitation in stroke patients with motor disorders can be effective to restore the affected function and to improve the performance of daily activities. Up to now, different methods and techniques have been used to recover motor functions in stroke patients, including motor training (active or passive mobilization) for the paretic limb, functional electrical stimulation, Constraint Induced Movement Therapy (CIMT) and robot-assisted rehabilitation. However, none of these has been conclusively proven to be more effective than the others. The clinical benefits induced by motor rehabilitation are closely related to "neuroplasticity", i.e. the ability of the central nervous system (CNS) to undergo structural and functional changes in response to physiological events, environmental stimuli and pathological events. After brain injuries, neurorehabilitation should aim at recovering functions and not vicariate them. In this context, observation and imitation of actions can recruit the mirror neuron system. Mirror neurons found both in the premotor cortex and parietal lobe, discharge both during the execution of a goal-directed action and the observation of the same or a similar action when performed by another individual. Electroencephalography (EEG) and Magnetoencephalography (MEG) studies showed that when an individual observes hand actions there is a desynchronization of the motor cortex similar, although weaker, to that occurring during actual execution of the observed movements. By means of Transcranial Magnetic Stimulation (TMS) it has been shown that motor-evoked potentials recorded from hand muscles increase during the observation of hand movements. Brain imaging studies showed that during the obse
    Sponsor: Neuromed IRCCS

    Current Primary Outcome:

    • Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA), (L Jääskö 1975) [ Time Frame: at baseline (T1) ]
      FMA is a measuring system of upper limb motor disability indicated to monitor the degree of motor recovery after stroke during hospitalization. It looks like a questionnaire that describes the reflexes, the synergies of movement, coordination and speed of movement. Each task can receive a score ranging from 0 (no movement) and 2 (normal movement). The cumulative score and the profile of the scores indicate the degree of activity remaining motor and the need of rehabilitation.
    • Functional Independence Measure (FIM), (Hamilton, 1987) [ Time Frame: at baseline (T1) ]
      FIM is a system of measurement of disability indicated to monitor patients during hospitalization. It looks like a questionnaire describing 18 activities of daily living (13-sphincteric motor, cognitive 5). Each task can receive a score ranging from 1 (complete dependence on others) and 7 (complete self-sufficiency). The cumulative score and the profile of the scores in the different items indicate the level of dependence even in the elementary activities of daily living, and above all the need for assistance.
    • FMA [ Time Frame: at end-treatment, that is 15 days after starting treatment (T2) ]
    • FIM [ Time Frame: at end-treatment, that is 15 days after starting treatment (T2) ]
    • FMA [ Time Frame: 2 months after starting treatment (T3) ]
    • FIM [ Time Frame: 2 months after starting treatment (T3) ]
    • FMA [&

      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • Functional Magnetic Resonance (fMRI) [ Time Frame: at baseline (T1) ]
        Magnetic resonance (MR) images will be recorded on a 3.0 Tesla "GE Signa HDxt 3T" using standard echo planar imaging and a standard radio frequency, head coil phased array for signal received. 39 axial slice positions (slice thickness, 3 mm; no interslice gap) orientated in the anterior±posterior commissure plane covering the brain volume above the fronto-temporo-parietal areas will be acquired. The following sequences will be used: gradient echo planar imaging, sequence repetition time (TR), 3000 s; signal (echo)-gathering time (TE), 20 ms; FOV, 288x288 mm (FOV, field of view); matrix size, 96x96; in-plane resolution, 3 x 3 x 3 mm. In addition, high-resolution anatomical images of the entire brain will be obtained using a FSPGR strongly T1-weighted sequences: TR, 7 ms; TE, 3 ms (flip angle, a =13°) ir prep = 450, FOV, 256 mm, matrix size, 256x256, 180 axial slices with 1 mm single slice thickness.
      • fMRI [ Time Frame: at end-treatment, that is 15 days after starting treatment (T2) ]


      Original Secondary Outcome: Same as current

      Information By: Neuromed IRCCS

      Dates:
      Date Received: September 5, 2014
      Date Started: June 2014
      Date Completion: June 2015
      Last Updated: September 9, 2014
      Last Verified: September 2014