Action Observation Training for Upper Limb Rehabilitation in Stroke Patients

NCT04622189 | Completed

• 1 other identifier: Brain_AOT_stroke
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Rehabilitation

Keywords

Stroke; Rehabilitation; AOT; kinematic; brain plasticity; mirror neuron system

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Applicability perception and satisfaction degree of the proposed treatment

  At week 4

Study Arms (1)

Action observation training for the upper limb rehabilitation

EXPERIMENTAL

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

Interventions

Action observation training 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.

Action observation training for the upper limb rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Should had experienced first ever ischemic or haemorrhagic stroke
• Fugl-Meyer Assessment \< 55
• normal or corrected to normal visual acuity

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• Istituto Italiano di Tecnologia: collaborator

Study Sites (1)

Sofia Straudi

Ferrara, Emilia-Romagna, 44124, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Luciano Fadiga, MD, PhD

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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 9, 2020
• Study Start: June 11, 2020
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: May 25, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)