An interventional study of Action observation training in Stroke Rehabilitation, sponsored by University Hospital of Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-25.
Sponsored by University Hospital of Ferrara · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the changes in physiological parameters and clinical scales resulting from treatment with AOT (action observation training) in subjects with subacute stroke. Furthermore, this study assess the perception of applicability and satisfaction degree for this kind of treatments.
After being informed about the study, all patients give written informed consent and will undergo a 1-week screening period to determine eligibility for study entry. Patient who meet the eligibility requirements will be given clinical and instrumental assessments before the start of treatment (T0) after 3 weeks (T1), at the end of the treatment (T2) and after 6 months (T3). A training program of 4 weeks including 250 videos of every day actions has been developed. Videos includes transitive and intransitive actions. Each week has a five day program, each day is divided in three sessions, in each session there are observation and imitation and attentional questions. AOT is always performed in conjunction with the conventional rehabilitation program.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →University Hospital of Ferrara is the lead sponsor of 110 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Neurorehabilitation training for the upper limb using AOT consists of watching videos related to every day actions. The subjects will be asked to reproduce, as accurately as possible, the actions proposed by the system, that will record their execution. In order to keep high motivation and participation in activities, simple games of skill will also be created that will involve the patient on both the motor and cognitive side. The training program includes 250 videos of every day transitive and intransitive actions: 20 consecutive sessions of 1 hour, five times a week over four weeks.
Device: Action observation training
Integration of four main tools: * PATIENT INTERFACE, which has been implemented to present stimuli with a user friendly interface, with personalized menu and with the possibility to manage the training program; user personal page containing user information and history of activities with daily performance are stored too. * MOCAP during action imitation will be recorded using MindMotion infrared camera to capture the trunk movement while an electromagnetic system (Trackstar from NDI) will be used to record fingers fine movements. * EEG data will be collected during video observation using an Enobio wireless system integrated with the platform.
Change in Fugl-Meyer Assessment Upper Extremity between four time points
Scale that assess the sensorimotor impairment in individuals who have had stroke.
Time frame: Baseline, week 3, week 4, after 6 months
Change in Barthel Index between four time points
Scale that measures disability or dependence in activities of daily living in stroke patients.
Time frame: Baseline, week 3, week 4,after 6 months
Change in Box and Block Test between four time points
To assess unilateral gross manual dexterity
Time frame: Baseline, week 3, week 4,after 6 months
Change in Modified Ashworth Scale between four time points
To measure spasticity. It consists of a 5-point nominal scale using subjective clinical assessments of tone ranging from 0 - 'No increases in tone' to 4 - 'Limb rigid in flexion or extension \[abduction/adduction\]'. An additional grade is added (1+) for the MAS to indicate resistance in the movement.
Time frame: Baseline, week 3, week 4,after 6 months
Change in Visual Analogue Scale between four time points
Scale that consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The length of the line is 10-cm. Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain.
Time frame: Baseline , week 3, week 4,after 6 months
Electroencephalography power in alpha band
EEG data will be recorded to test presence of particular changes in brain activity in during AOT training. In particular plasticity and mu rhythm desynchronization will be investigated.
Time frame: Up to 1 month
Motion Capture (MOCAP) recordings
Kinematic data of trunk and affected hand will be recorded during subject imitations and will be analysed to assess any improvements.
Time frame: Up to 1 month
Change in Oxford Cognitive Screen between two time points
is a stroke-specific cognitive screen
Time frame: Baseline and week 4
Applicability perception and satisfaction degree of the proposed treatment
self-report questionnaire using a 5 point Likert scale (1 - Strongly disagree; 5 - Strongly agree). Higher score indicates greater satisfaction with the treatment.
Time frame: At week 4
Plan to share: No
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University Hospital of Ferrara