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Action Observation Training for Upper Limb Rehabilitation in Stroke Patients

Primary Purpose

Stroke Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Action observation training
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Rehabilitation focused on measuring Stroke, Rehabilitation, AOT, kinematic, brain plasticity, mirror neuron system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sofia Straudi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Action observation training for the upper limb rehabilitation

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Fugl-Meyer Assessment Upper Extremity between four time points
Scale that assess the sensorimotor impairment in individuals who have had stroke.
Change in Barthel Index between four time points
Scale that measures disability or dependence in activities of daily living in stroke patients.
Change in Box and Block Test between four time points
To assess unilateral gross manual dexterity
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.
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.
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.
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.
Change in Oxford Cognitive Screen between two time points
is a stroke-specific cognitive screen

Secondary Outcome Measures

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.

Full Information

First Posted
October 29, 2020
Last Updated
May 24, 2022
Sponsor
University Hospital of Ferrara
Collaborators
Istituto Italiano di Tecnologia
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1. Study Identification

Unique Protocol Identification Number
NCT04622189
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
December 9, 2021 (Actual)
Study Completion Date
December 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara
Collaborators
Istituto Italiano di Tecnologia

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation
Keywords
Stroke, Rehabilitation, AOT, kinematic, brain plasticity, mirror neuron system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Action observation training for the upper limb rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Action observation training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Assessment Upper Extremity between four time points
Description
Scale that assess the sensorimotor impairment in individuals who have had stroke.
Time Frame
Baseline, week 3, week 4, after 6 months
Title
Change in Barthel Index between four time points
Description
Scale that measures disability or dependence in activities of daily living in stroke patients.
Time Frame
Baseline, week 3, week 4,after 6 months
Title
Change in Box and Block Test between four time points
Description
To assess unilateral gross manual dexterity
Time Frame
Baseline, week 3, week 4,after 6 months
Title
Change in Modified Ashworth Scale between four time points
Description
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.
Time Frame
Baseline, week 3, week 4,after 6 months
Title
Change in Visual Analogue Scale between four time points
Description
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.
Time Frame
Baseline , week 3, week 4,after 6 months
Title
Electroencephalography power in alpha band
Description
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.
Time Frame
Up to 1 month
Title
Motion Capture (MOCAP) recordings
Description
Kinematic data of trunk and affected hand will be recorded during subject imitations and will be analysed to assess any improvements.
Time Frame
Up to 1 month
Title
Change in Oxford Cognitive Screen between two time points
Description
is a stroke-specific cognitive screen
Time Frame
Baseline and week 4
Secondary Outcome Measure Information:
Title
Applicability perception and satisfaction degree of the proposed treatment
Description
self-report questionnaire using a 5 point Likert scale (1 - Strongly disagree; 5 - Strongly agree). Higher score indicates greater satisfaction with the treatment.
Time Frame
At week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciano Fadiga, MD, PhD
Organizational Affiliation
Section of Human Physiology, University of Ferrara (Ferrara, Italy)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD, PhD
Organizational Affiliation
Department of Neuroscience and Rehabilitation, University Hospital of Ferrara (Ferrara, Italy)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thierry Pozzo, PhD
Organizational Affiliation
IIT; Istituto Italiano di Tecnologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sofia Straudi
City
Ferrara
State/Province
Emilia Romagna
ZIP/Postal Code
44124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Action Observation Training for Upper Limb Rehabilitation in Stroke Patients

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