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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02235350 |
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Date of registration:
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05/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Action Observation Treatment (AOT) as a Rehabilitation Tool
AOT |
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Scientific title:
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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 |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02235350 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Health Services Research
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Giovanni Buccino, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Neuromed IRCCS |
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Name:
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Giovanni Buccino, MD, PhD |
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Address:
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Telephone:
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Email:
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buccino@unicz.it |
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Affiliation:
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Name:
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Giovanni Buccino, MD, PhD |
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Address:
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Telephone:
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Email:
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buccino@unicz.it |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stroke, Acute Hemiplegia, Apraxia
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Intervention(s)
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Other: Action Observation Treatment (AOT)
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Other: Observation of videos with no motor content (MNO)
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Primary Outcome(s)
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FMA
[Time Frame: 6 months after starting treatment (T4)]
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FIM
[Time Frame: 6 months after starting treatment (T4)]
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FIM
[Time Frame: at end-treatment, that is 15 days after starting treatment (T2)]
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FMA
[Time Frame: 2 months after starting treatment (T3)]
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FMA
[Time Frame: at end-treatment, that is 15 days after starting treatment (T2)]
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Functional Independence Measure (FIM), (Hamilton, 1987)
[Time Frame: at baseline (T1)]
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Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA), (L Jääskö 1975)
[Time Frame: at baseline (T1)]
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FIM
[Time Frame: 2 months after starting treatment (T3)]
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Secondary Outcome(s)
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Functional Magnetic Resonance (fMRI)
[Time Frame: at baseline (T1)]
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fMRI
[Time Frame: at end-treatment, that is 15 days after starting treatment (T2)]
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Secondary ID(s)
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neuromedbuccino01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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