Stroke RehabilitationNCT04622189
Action Observation Training for Upper Limb Rehabilitation in Stroke Patients
A study testing Action observation training in people with Stroke Rehabilitation, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Rehabilitation
- What is being tested?
- Action observation training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jun 2020to 9 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Should had experienced first ever ischemic or haemorrhagic stroke
- Fugl-Meyer Assessment < 55
- normal or corrected to normal visual acuity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Action observation training
- Keywords
- Stroke, Rehabilitation, AOT, kinematic, brain plasticity, mirror neuron system
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observation trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Action observation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment Upper Extremity between four time points
Scale that assess the sensorimotor impairment in individuals who have had stroke.
Measured: 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.
Measured: Baseline, week 3, week 4,after 6 months
Change in Box and Block Test between four time points
To assess unilateral gross manual dexterity
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 month
Change in Oxford Cognitive Screen between two time points
is a stroke-specific cognitive screen
Measured: Baseline and week 4
Secondary outcomes (1)
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.
Measured: At week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start11 Jun 2020
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Italiano di Tecnologia
- Responsible party
- Principal investigator, Sofia Straudi, University Hospital of Ferrara
- Investigators
- Luciano Fadiga, MD, PhD, Study director, Section of Human Physiology, University of Ferrara (Ferrara, Italy)Sofia Straudi, MD, PhD, Principal investigator, Department of Neuroscience and Rehabilitation, University Hospital of Ferrara (Ferrara, Italy)Thierry Pozzo, PhD, Principal investigator, IIT; Istituto Italiano di Tecnologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622189
- Sponsor's protocol ID
- Brain_AOT_stroke
- Status last verified
- May 2022
- First submitted
- 29 Oct 2020
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-rehabilitation of Upper Limb Stroke Patients Through Motor Resonance and Mirror Neurons
- ClinicalTrials.gov ID
- NCT04622189
- Acronym / sponsor ID
- Brain_AOT_stroke
- Conditions
- Stroke Rehabilitation
- Keywords
- Stroke, Rehabilitation, AOT, kinematic, brain plasticity, mirror neuron system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Istituto Italiano di Tecnologia
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Dec 2021 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Action observation training for the upper limb rehabilitation | Experimental | Device: Action observation trainingNeurorehabilitation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Should had experienced first ever ischemic or haemorrhagic stroke
- Fugl-Meyer Assessment < 55
- normal or corrected to normal visual acuity
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action observation trainingIntegration 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. | Device | Action observation training for the upper limb rehabilitation |
Primary outcome
Change in Fugl-Meyer Assessment Upper Extremity between four time points
Time frame: Baseline, week 3, week 4, after 6 months
Scale that assess the sensorimotor impairment in individuals who have had stroke.
Change in Barthel Index between four time points
Time frame: Baseline, week 3, week 4,after 6 months
Scale that measures disability or dependence in activities of daily living in stroke patients.
Change in Box and Block Test between four time points
Time frame: Baseline, week 3, week 4,after 6 months
To assess unilateral gross manual dexterity
Change in Modified Ashworth Scale between four time points
Time frame: Baseline, week 3, week 4,after 6 months
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
Time frame: Baseline , week 3, week 4,after 6 months
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
Time frame: Up to 1 month
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
Time frame: Up to 1 month
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
Time frame: Baseline and week 4
is a stroke-specific cognitive screen
1 secondary outcome
Applicability perception and satisfaction degree of the proposed treatment
Time frame: At week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke Rehabilitation
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Recruiting
Cervical tsDCS on Stroke Patients
Functional Recovery, Motor Rehabilitation
Not yet recruiting
Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
Stroke, Upper Extremity Paresis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciano Fadiga, MD, PhD study director
Section of Human Physiology, University of Ferrara (Ferrara, Italy)
Sofia Straudi, MD, PhD principal investigator
Department of Neuroscience and Rehabilitation, University Hospital of Ferrara (Ferrara, Italy)
Thierry Pozzo, PhD principal investigator
IIT; Istituto Italiano di Tecnologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action observation training in people with Stroke Rehabilitation, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Assessment Upper Extremity between four time points (time frame: Baseline, week 3, week 4, after 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.