Clinical trial NCT04622189: Action Observation Training for Upper Limb Rehabilitation in Stroke Patients
Official title: Neuro-rehabilitation of Upper Limb Stroke Patients Through Motor Resonance and Mirror Neurons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Rehabilitation
Keywords: Stroke
Rehabilitation
AOT
kinematic
brain plasticity
mirror neuron system
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
Collaborators: name: Istituto Italiano di Tecnologia
First posted: 2020-11-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Fugl-Meyer Assessment Upper Extremity between four time points
timeFrame: Baseline, week 3, week 4, after 6 months
measure: Change in Barthel Index between four time points
timeFrame: Baseline, week 3, week 4,after 6 months
measure: Change in Box and Block Test between four time points
timeFrame: Baseline, week 3, week 4,after 6 months
measure: Change in Modified Ashworth Scale between four time points
timeFrame: Baseline, week 3, week 4,after 6 months
measure: Change in Visual Analogue Scale between four time points
timeFrame: Baseline , week 3, week 4,after 6 months
measure: Electroencephalography power in alpha band
timeFrame: Up to 1 month
measure: Motion Capture (MOCAP) recordings
timeFrame: Up to 1 month
measure: Change in Oxford Cognitive Screen between two time points
timeFrame: Baseline and week 4
Secondary outcomes:
measure: Applicability perception and satisfaction degree of the proposed treatment
timeFrame: At week 4
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Sofia Straudi
state: Emilia Romagna
Study officials:
affiliation: Section of Human Physiology, University of Ferrara (Ferrara, Italy)
name: Luciano Fadiga, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Neuroscience and Rehabilitation, University Hospital of Ferrara (Ferrara, Italy)
name: Sofia Straudi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IIT; Istituto Italiano di Tecnologia
name: Thierry Pozzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: