Action Observation Training for Upper Limb Rehabilitation in Stroke Patients

NCT ID: NCT04622189

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-11
• Study Completion Date: 2021-12-09

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.

Conditions

Stroke Rehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Action observation training for the upper limb rehabilitation

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.

Group Type: EXPERIMENTAL

Action observation training

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Italiano di Tecnologia

OTHER

Sponsor Role: collaborator

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Sofia Straudi

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciano Fadiga, MD, PhD

Role: STUDY_DIRECTOR

Section of Human Physiology, University of Ferrara (Ferrara, Italy)

Sofia Straudi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neuroscience and Rehabilitation, University Hospital of Ferrara (Ferrara, Italy)

Thierry Pozzo, PhD

Role: PRINCIPAL_INVESTIGATOR

IIT; Istituto Italiano di Tecnologia

Locations

Sofia Straudi

Ferrara, Emilia-Romagna, Italy

Countries

Italy

Other Identifiers

Brain_AOT_stroke

Identifier Type: -

Identifier Source: org_study_id