Action Observation Training for Upper Limb Rehabilitation in Stroke Patients

Neuro-rehabilitation of Upper Limb Stroke Patients Through Motor Resonance and Mirror Neurons

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.

Study Overview

• Status: Completed
• Conditions: Stroke Rehabilitation
• Intervention / Treatment: Device: Action observation training

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Emilia Romagna
    • Ferrara, Emilia Romagna, Italy, 44124
      • Sofia Straudi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fugl-Meyer Assessment Upper Extremity between four time points	Scale that assess the sensorimotor impairment in individuals who have had stroke.	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.	Baseline, week 3, week 4,after 6 months
Change in Box and Block Test between four time points	To assess unilateral gross manual dexterity	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.	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.	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.	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.	Up to 1 month
Change in Oxford Cognitive Screen between two time points	is a stroke-specific cognitive screen	Baseline and week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At week 4

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara
• Collaborators: Istituto Italiano di Tecnologia
• Investigators: Study Director: Luciano Fadiga, MD, PhD, Section of Human Physiology, University of Ferrara (Ferrara, Italy); Principal Investigator: Sofia Straudi, MD, PhD, Department of Neuroscience and Rehabilitation, University Hospital of Ferrara (Ferrara, Italy); Principal Investigator: Thierry Pozzo, PhD, IIT; Istituto Italiano di Tecnologia

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Actual): December 9, 2021
• Study Completion (Actual): December 9, 2021

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; mirror neuron system; brain plasticity; kinematic; AOT
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Brain_AOT_stroke

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No