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Action Observation Treatment (AOT) as a Rehabilitation Tool (AOT)

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ClinicalTrials.gov Identifier: NCT02235350
Recruitment Status : Unknown
Verified September 2014 by Giovanni Buccino, Neuromed IRCCS.
Recruitment status was:  Recruiting
First Posted : September 9, 2014
Last Update Posted : September 10, 2014
Sponsor:
Information provided by (Responsible Party):
Giovanni Buccino, Neuromed IRCCS

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).

Condition or disease Intervention/treatment Phase
Stroke, Acute Hemiplegia, Apraxia Other: Action Observation Treatment (AOT) Other: Observation of videos with no motor content (MNO) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
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
Study Start Date : June 2014
Actual Primary Completion Date : September 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Action Observation Treatment (AOT)
Conventional physiotherapy + Action Observation Treatment
Other: Action Observation Treatment (AOT)
Participants will be asked to carefully observe at a computer screen videos depicting different daily actions. Each action will consist of 3 to 4 constituent motor acts. Each motor act will be presented for 3 minutes. As a whole, therefore, each video will be 12 minutes long. At the end of each motor act presentation, participants will be required to execute with the affected hand the observed motor sequence for 2 minutes. Each single rehabilitation session based on AOT will last 20 minutes. We will record ten daily actions for a total of ten video-clips. Participants will be presented with each video clips, twice a day, in order of complexity as judged by the experimenter. Participants will undergo 10 sessions a week, each lasting 20 minutes for 2 weeks.

Sham Comparator: Observation of videos with no motor content (MNO)
Conventional physiotherapy + Observation of videos with no motor content (MNO)
Other: Observation of videos with no motor content (MNO)
Participants will be asked to observe video clips with no specific motor content. Videos will concern scientific, geographical and historical issues. As for cases, video clips will be divided into three to four parts. At the end of each part, controls will execute the same actions as cases, in the same order. In this way cases and controls will undergo the same amount of motor practice and receive the same amount of visual stimulation, the only difference being the content of visual stimuli.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. FMA [ Time Frame: at end-treatment, that is 15 days after starting treatment (T2) ]
  4. FIM [ Time Frame: at end-treatment, that is 15 days after starting treatment (T2) ]
  5. FMA [ Time Frame: 2 months after starting treatment (T3) ]
  6. FIM [ Time Frame: 2 months after starting treatment (T3) ]
  7. FMA [ Time Frame: 6 months after starting treatment (T4) ]
  8. FIM [ Time Frame: 6 months after starting treatment (T4) ]

Secondary Outcome Measures :
  1. 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.

  2. fMRI [ Time Frame: at end-treatment, that is 15 days after starting treatment (T2) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first ever ischemic or hemorrhagic stroke confirmed by CT/MRI, no later than 30 days from acute event, or chronic stroke patients (more than three months from the acute event) with apraxia,
  • aged 18-85 years,
  • Upper limb plegia or paresis with muscle strength in grasping Medical Research Council (MRC) < 4,
  • ability to understand and carry out simple verbal instruction,
  • Mini Mental State Examination (MMSE) ≥ 20.

Exclusion Criteria:

  • previous cerebral ischemic or hemorrhagic event,
  • severe psychiatric disorders,
  • pre-existing rheumatic, orthopedic or muscular affection involving the upper limb,
  • moderate to severe fluent aphasia,
  • Neglect.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235350


Contacts
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Contact: Giovanni Buccino, MD, PhD buccino@unicz.it

Locations
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Italy
Neuromed IRCCS, Istituto Neurologico Mediterraneo Recruiting
Pozzilli, Isernia, Italy, 86077
Contact: Giovanni Buccino, MD, PhD       buccino@unicz.it   
Sub-Investigator: Daniela Aprile, PT         
Sponsors and Collaborators
Neuromed IRCCS
Investigators
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Principal Investigator: Giovanni Buccino, MD, PhD Neuromed IRCCS

Additional Information:
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Responsible Party: Giovanni Buccino, MD, PhD, Neuromed IRCCS
ClinicalTrials.gov Identifier: NCT02235350     History of Changes
Other Study ID Numbers: neuromedbuccino01
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: September 10, 2014
Last Verified: September 2014
Keywords provided by Giovanni Buccino, Neuromed IRCCS:
Adult
Male
Female
Neuronal Plasticity
Imitative Behavior/physiology
Magnetic Resonance Imaging
Psychomotor Disorders/rehabilitation
Follow-up Studies
Video Recording
Physical Therapy Modalities
Recovery of Function
Action Observation Treatment
Mirror Neuron System
Stroke/rehabilitation
Upper Limb
Additional relevant MeSH terms:
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Stroke
Hemiplegia
Apraxias
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Psychomotor Disorders
Neurobehavioral Manifestations