Stroke Rehabilitation
Conditions
Keywords
Stroke, Rehabilitation, AOT, kinematic, brain plasticity, mirror neuron system
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Istituto Italiano di Tecnologia
University Hospital of Ferrara
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Should had experienced first ever ischemic or haemorrhagic stroke * Fugl-Meyer Assessment \< 55 * normal or corrected to normal visual acuity
Exclusion criteria
* presence of severe neuropsychological disorders * medical conditions likely to interfere with the ability to safely complete the study protocol * pain in the upper limb assessed with the Visual Analogue Scale (VAS)\> 7 * intracranial metal implants * history of seizures or epilepsy * severe cardiopulmonary, renal, and hepatic diseases * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oxford Cognitive Screen between two time points | Baseline and week 4 | is a stroke-specific cognitive screen |
| Change in Fugl-Meyer Assessment Upper Extremity between four time points | Baseline, week 3, week 4, after 6 months | Scale that assess the sensorimotor impairment in individuals who have had stroke. |
| Change in Barthel Index between four time points | Baseline, week 3, week 4,after 6 months | Scale that measures disability or dependence in activities of daily living in stroke patients. |
| Change in Box and Block Test between four time points | Baseline, week 3, week 4,after 6 months | To assess unilateral gross manual dexterity |
| Change in Modified Ashworth Scale between four time points | Baseline, week 3, week 4,after 6 months | 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. |
| Change in Visual Analogue Scale between four time points | Baseline , week 3, week 4,after 6 months | 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. |
| Electroencephalography power in alpha band | Up to 1 month | 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. |
| Motion Capture (MOCAP) recordings | Up to 1 month | Kinematic data of trunk and affected hand will be recorded during subject imitations and will be analysed to assess any improvements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Applicability perception and satisfaction degree of the proposed treatment | At week 4 | self-report questionnaire using a 5 point Likert scale (1 - Strongly disagree; 5 - Strongly agree). Higher score indicates greater satisfaction with the treatment. |
Countries
Italy
Outcome results
None listed