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
|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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
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.
- 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 [ Time Frame: 6 months after starting treatment (T4) ]
- FIM [ Time Frame: 6 months after starting treatment (T4) ]
- 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) ]
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
|Contact: Giovanni Buccino, MD, PhDemail@example.com|
|Neuromed IRCCS, Istituto Neurologico Mediterraneo||Recruiting|
|Pozzilli, Isernia, Italy, 86077|
|Contact: Giovanni Buccino, MD, PhD firstname.lastname@example.org|
|Sub-Investigator: Daniela Aprile, PT|
|Principal Investigator:||Giovanni Buccino, MD, PhD||Neuromed IRCCS|