StrokePHOENICSNCT04560764

Physiotherapy and Action-Observation Therapy: An Integrated Approach for Upper Limb Impairment in Subacute Stroke

A study testing Virtual Reality, Action Observation Therapy and Landscape video in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: Virtual Reality, Action Observation Therapy and Landscape video
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteItaly
Study dates: 1 Jan 2023to 30 Dec 2023
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

Participant who suffered from an ictus 3 to 6 months before (subacute phase);
Baseline scoring of the Upper Extremity portion of the Fugl Meyer between 20 and 60.

Who cannot join

Other neurological pathologies (including previous strokes);
Visual field impairments;
Neuropsychological deficits that prevents the understanding of the instructions or the execution of the treatment (e.g. aphasia, apraxia, neglect);
Baseline scoring of the Mini Mental State Examination (MMSE) lower that 24 (MMSE < 24);
Orthopaedic or musculoskeletal limitations that do not allow the execution of the treatment;
Clinical instability;

Show all 9Show fewer

Inability to understand the instructions needed to perform the test and the planned evaluations;
People with electronic medical devices such as pacemakers;
Medical history of epilepsy.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza
Rovato, Brescia, 25038

Other trials in Italy

About this study

Official title: Virtual Reality and Action-Observation Therapy: An Integrated Approach Supported by Novel Technologies for Upper Limb Impairment in Subacute Stroke

Motor impairment is one of the most common result of a stroke, which causes disability and difficulties in activities of daily living. This motor impairment can concern the upper limb or the lower limb, or both. Several studies investigates the efficacy of different treatment approaches on upper limb and hand function. None of them combined exercise in a virtual context with Action Observation Therapy, consisting in watching an action before doing it.

This study evaluates the addition of Action Observation Therapy (AOT) to Virtual Reality (VR) in the rehabilitation of upper limb impairment in subacute stroke patients. Half of participants will see a video demonstrating the exercise to be performed before its actual execution, while the other half will see a video of a natural landscape followed by the same exercises the other group performs. All the patients will receive additional usual treatment.

Read the detailed description

In this study, the intervention will be conducted using a system composed by multiple devices, which are:

HTC Vive (HTC, headset e Steam station): three-dimensional viewer used for the implementation of the immersive virtual environment, allows both the visualization of the videos and of the exercises to be performed;
Leap Motion Controller (infrared camera): contactless device for tracking the movement of the patient's fingers and hand;
Zed Mini (RGB binocular camera and depth camera): Stereo Labs' Zed Mini stereoscopic camera is mounted on the HTC Vive viewer to allow virtual elements to be overlapped within the environment;
Cometa Wavetrack (transmitter/receiver and Inertial Measurement Units): system for upper limb movement tracking through the use of four wireless inertial sensors applied to the chest, to the arm and to the forearm of the participant through elastic bands and to the hand of the participant through skin-compatible double-sided adhesive patches.

All the devices have been tested to ensure safety of the participants and are provided with the appropriate documentation of declaration of conformity according to the European reference regulations. A careful risk analysis was carried out to ensure the safety of the participants.

All the devices will be working simultaneously during each session of treatment. For the experimental group, the instrumentation will be used to see the video of the exercises that the participants will be later asked to perform and to actually perform them; in the control group, it will be used to see a video of a natural landscape with a 180° perspective and to perform the same exercises than the experimental group.

The devices will be used both for the execution of the exercises both to collect information listed in the outcomes section as secondary outcomes: in particular, these information will be provided by the Leap Motion and by the Cometa Wavetrack devices.

Conditions: Stroke
Being tested: Virtual Reality, Action Observation Therapy, Landscape video, Standard treatment
Keywords: Upper limb impairment, Virtual Reality, Action Observation Therapy
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual RealityDevice
Participants in both groups will attend 10 sessions of approximately 30 minutes each three times a week. Each session contemplates the execution of a single repetition of two minutes of each of the four exercises.
There are four exercises:
1. Reaching: the participant is requested to reach a target in front of him with the paretic hand; the target will appear in a different place every time;
2. Reaching and grasping: the participant is requested to grab a wooden cube with the paretic hand and place it into a bowl positioned in front of him; the cube will appear in a different place every time;
3. Goalkeeper: the participant is requested to block a ball coming towards him with the paretic hand; the ball will appear in a different place every time;
4. Occupational task: the participant is requested to grab four cans, one at time, with the paretic hand and place them on four targets placed on a hemispherical arch.
Each exercise provides six levels of increasing difficulty.
Action Observation TherapyDevice
Before the execution of the exercises described in the intervention "Virtual Reality", the participants in the experimental group will see a video demonstrating the same exercise (according to the level of difficulty selected) he will be later asked to perform for two minutes.
Landscape videoDevice
Before the execution of the exercises described in the intervention "Virtual Reality", the participants in the sham comparator group will see a video of a natural landscape for two minutes.
Standard treatmentOther
Participants in both groups will receive the standard treatment, one hour a day for three days a week.

Study groups in NCT04560764
Study group	Role	What they receive
Virtual Reality + Action Observation Therapy	Experimental	Participants will see a video demonstrating the exercise they will be later asked to perform. The same procedure is performed for each of the four different exercises. Receives: Device: Virtual Reality; Device: Action Observation Therapy; Other: Standard treatment
Virtual Reality + Landscape video	Sham comparator	Participants will see a video demonstrating a natural landscape and later they will perform an exercise. The same procedure is performed for each of the four different exercises. Receives: Device: Virtual Reality; Device: Landscape video; Other: Standard treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of Upper limb function
Upper extremity portion of the Fugl Meyer (UE-FM). This scale measures the function of the upper limb in a range of 0 to 66 points. Higher values represent a better outcome.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of hand dexterity
Box and Block test. This test examines hand dexterity measuring the number of wooden blocks the participant is able to move from one box to another with the paretic hand in 60 seconds. Higher values represent a better outcome.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).

Secondary outcomes (14)

Change of autonomy
Barthel Index. This scale measures the ability of the subject to perform activities of daily living. Range 0-100. Higher values represent a better outcome.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of quality of Life
EuroQol-5D questionnaire. This questionnaire measures the quality of life. Range 5-15. Lower values represent a better outcome.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of level completed
Most difficult level the participant is able to complete, from 1 to 6. Higher values represent a better performance.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of number of correct tasks
Number of tasks the participants performs correctly. Higher values represent a better performance.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of reaction time
Seconds from the appearance of the target to the start of the movement. Lower values represent a better outcome.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of interaction time
Seconds from the appearance of the target to its reaching. Lower values represent a better outcome.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of mean time of exercise execution
Seconds required for single exercise execution. Lower values represent a better outcome.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Level of Satisfaction
Likert 1-5. This scale measures the level of satisfaction of the subject regarding the treatment. Higher values represent a better outcome.
Measured: At the end of the treatment (4 weeks).
Change of Hand Max Reaching Velocity
Maximal velocity (meters/seconds) of the hand movement during reaching of the target. Higher values represent a better outcome.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of % Cycle Hand Max Velocity
Dividing the interaction time between the hand and the object into 100 parts, it represents the moment in which the hand reaches the maximal velocity.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of Mean SPARC
Spectral parameter related to the smoothness of the movement. Negative values lower than -1 stand for lower smoothness.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of Mean Reach Path Ratio
Parameter calculated as total distance traveled by the wrist of the subject divided by the length of a straight-line path from the reach's starting point (hand resting on the table) to ending point (target). Values equal or close to +1 represent a straight trajectory, while higher values stand for a more curved one.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of Tip Max Distance
Maximal distance between the thumb and index fingertips.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of Tip Max Velocity
Maximal velocity of opening and closing between the thumb and index fingertips.
Measured: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202330 Dec 2023

First posted23 Sep 2020
Study start1 Jan 2023 (estimated)
Primary completion1 Jun 2023 (estimated)
Study completion30 Dec 2023 (estimated)

Why it stopped: Changes in the rehabilitation service that no longer allowed the recruitment of patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for StrokeStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04560764
Sponsor's protocol ID: FDG_AOTVR
Acronym: PHOENICS
Status last verified: Aug 2024
First submitted: 2 Oct 2019
Last updated: 12 Aug 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.
PubMed 25387001
Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.
PubMed 29156493
Borges LR, Fernandes AB, Melo LP, Guerra RO, Campos TF. Action observation for upper limb rehabilitation after stroke. Cochrane Database Syst Rev. 2018 Oct 31;10(10):CD011887. doi: 10.1002/14651858.CD011887.pub2.
PubMed 30380586
Shih TY, Wu CY, Lin KC, Cheng CH, Hsieh YW, Chen CL, Lai CJ, Chen CC. Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial. Trials. 2017 Oct 4;18(1):459. doi: 10.1186/s13063-017-2205-z.
PubMed 28978349
Kim C-H, Bang D-H. Action observation training enhances upper extremity function in subacute stroke survivor with moderate impairment: a double-blind, randomized controlled pilot trial. J Korean Soc Phys Med. 2016;11(1):133-140. doi:10.13066/kspm.2016.11.1.133
Franceschini M, Ceravolo MG, Agosti M, Cavallini P, Bonassi S, Dall'Armi V, Massucci M, Schifini F, Sale P. Clinical relevance of action observation in upper-limb stroke rehabilitation: a possible role in recovery of functional dexterity. A randomized clinical trial. Neurorehabil Neural Repair. 2012 Jun;26(5):456-62. doi: 10.1177/1545968311427406. Epub 2012 Jan 10.
PubMed 22235059
Lin KC, Chuang LL, Wu CY, Hsieh YW, Chang WY. Responsiveness and validity of three dexterous function measures in stroke rehabilitation. J Rehabil Res Dev. 2010;47(6):563-71. doi: 10.1682/jrrd.2009.09.0155.
PubMed 20848369
Kuk EJ, Kim JM, Oh DW, Hwang HJ. Effects of action observation therapy on hand dexterity and EEG-based cortical activation patterns in patients with post-stroke hemiparesis. Top Stroke Rehabil. 2016 Oct;23(5):318-25. doi: 10.1080/10749357.2016.1157972. Epub 2016 Mar 31.
PubMed 27077994
Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.
PubMed 8024419
Fu J, Zeng M, Shen F, Cui Y, Zhu M, Gu X, Sun Y. Effects of action observation therapy on upper extremity function, daily activities and motion evoked potential in cerebral infarction patients. Medicine (Baltimore). 2017 Oct;96(42):e8080. doi: 10.1097/MD.0000000000008080.
PubMed 29049194
Saposnik G, Cohen LG, Mamdani M, Pooyania S, Ploughman M, Cheung D, Shaw J, Hall J, Nord P, Dukelow S, Nilanont Y, De Los Rios F, Olmos L, Levin M, Teasell R, Cohen A, Thorpe K, Laupacis A, Bayley M; Stroke Outcomes Research Canada. Efficacy and safety of non-immersive virtual reality exercising in stroke rehabilitation (EVREST): a randomised, multicentre, single-blind, controlled trial. Lancet Neurol. 2016 Sep;15(10):1019-27. doi: 10.1016/S1474-4422(16)30121-1. Epub 2016 Jun 27.
PubMed 27365261
Dorman PJ, Waddell F, Slattery J, Dennis M, Sandercock P. Is the EuroQol a valid measure of health-related quality of life after stroke? Stroke. 1997 Oct;28(10):1876-82. doi: 10.1161/01.str.28.10.1876.
PubMed 9341688
Franceschini M, La Porta F, Agosti M, Massucci M; ICR2 group. Is health-related-quality of life of stroke patients influenced by neurological impairments at one year after stroke? Eur J Phys Rehabil Med. 2010 Sep;46(3):389-99. Epub 2010 Apr 13.
PubMed 20927005
Lee KW, Kim SB, Lee JH, Lee SJ, Kim JW. Effect of Robot-Assisted Game Training on Upper Extremity Function in Stroke Patients. Ann Rehabil Med. 2017 Aug;41(4):539-546. doi: 10.5535/arm.2017.41.4.539. Epub 2017 Aug 31.
PubMed 28971037
Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4.
PubMed 19608100

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
Acute Stroke, Upper Limb Motor Deficit

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtual Reality and Action-Observation Therapy: An Integrated Approach Supported by Novel Technologies for Upper Limb Impairment in Subacute Stroke
ClinicalTrials.gov ID: NCT04560764
Acronym / sponsor ID: PHOENICS / FDG_AOTVR
Conditions: Stroke
Keywords: Upper limb impairment, Virtual Reality, Action Observation Therapy
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Changes in the rehabilitation service that no longer allowed the recruitment of patients
Enrolment: 0 participants (actual)
Lead sponsor: Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
Study start: 1 Jan 2023 (estimated)
Primary completion: 1 Jun 2023 (estimated)
Study completion: 30 Dec 2023 (estimated)
First posted: 23 Sep 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.

Detailed description

In this study, the intervention will be conducted using a system composed by multiple devices, which are:

HTC Vive (HTC, headset e Steam station): three-dimensional viewer used for the implementation of the immersive virtual environment, allows both the visualization of the videos and of the exercises to be performed;
Leap Motion Controller (infrared camera): contactless device for tracking the movement of the patient's fingers and hand;
Zed Mini (RGB binocular camera and depth camera): Stereo Labs' Zed Mini stereoscopic camera is mounted on the HTC Vive viewer to allow virtual elements to be overlapped within the environment;
Cometa Wavetrack (transmitter/receiver and Inertial Measurement Units): system for upper limb movement tracking through the use of four wireless inertial sensors applied to the chest, to the arm and to the forearm of the participant through elastic bands and to the hand of the participant through skin-compatible double-sided adhesive patches.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Virtual Reality + Action Observation Therapy	Experimental	Device: Virtual Reality, Device: Action Observation Therapy, Other: Standard treatmentParticipants will see a video demonstrating the exercise they will be later asked to perform. The same procedure is performed for each of the four different exercises.
Virtual Reality + Landscape video	Sham comparator	Device: Virtual Reality, Device: Landscape video, Other: Standard treatmentParticipants will see a video demonstrating a natural landscape and later they will perform an exercise. The same procedure is performed for each of the four different exercises.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participant who suffered from an ictus 3 to 6 months before (subacute phase);
Baseline scoring of the Upper Extremity portion of the Fugl Meyer between 20 and 60.

Key exclusion criteria (9 listed)

Other neurological pathologies (including previous strokes);
Visual field impairments;
Neuropsychological deficits that prevents the understanding of the instructions or the execution of the treatment (e.g. aphasia, apraxia, neglect);
Baseline scoring of the Mini Mental State Examination (MMSE) lower that 24 (MMSE < 24);
Orthopaedic or musculoskeletal limitations that do not allow the execution of the treatment;

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
Virtual RealityParticipants in both groups will attend 10 sessions of approximately 30 minutes each three times a week. Each session contemplates the execution of a single repetition of two minutes of each of the four exercises. There are four exercises: 1. Reaching: the participant is requested to reach a target in front of him with the paretic hand; the target will appear in a different place every time; 2. Reaching and grasping: the participant is requested to grab a wooden cube with the paretic hand and place it into a bowl positioned in front of him; the cube will appear in a different place every time; 3. Goalkeeper: the participant is requested to block a ball coming towards him with the paretic hand; the ball will appear in a different place every time; 4. Occupational task: the participant is requested to grab four cans, one at time, with the paretic hand and place them on four targets placed on a hemispherical arch. Each exercise provides six levels of increasing difficulty.	Device	Virtual Reality + Action Observation Therapy, Virtual Reality + Landscape video
Action Observation TherapyBefore the execution of the exercises described in the intervention "Virtual Reality", the participants in the experimental group will see a video demonstrating the same exercise (according to the level of difficulty selected) he will be later asked to perform for two minutes.	Device	Virtual Reality + Action Observation Therapy
Landscape videoBefore the execution of the exercises described in the intervention "Virtual Reality", the participants in the sham comparator group will see a video of a natural landscape for two minutes.	Device	Virtual Reality + Landscape video
Standard treatmentParticipants in both groups will receive the standard treatment, one hour a day for three days a week.	Other	Virtual Reality + Action Observation Therapy, Virtual Reality + Landscape video

Primary outcome

Change of Upper limb function
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Upper extremity portion of the Fugl Meyer (UE-FM). This scale measures the function of the upper limb in a range of 0 to 66 points. Higher values represent a better outcome.
Change of hand dexterity
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Box and Block test. This test examines hand dexterity measuring the number of wooden blocks the participant is able to move from one box to another with the paretic hand in 60 seconds. Higher values represent a better outcome.

14 secondary outcomes

Change of autonomy
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of quality of Life
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of level completed
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of number of correct tasks
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of reaction time
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of interaction time
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of mean time of exercise execution
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Level of Satisfaction
Time frame: At the end of the treatment (4 weeks).
Change of Hand Max Reaching Velocity
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of % Cycle Hand Max Velocity
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of Mean SPARC
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of Mean Reach Path Ratio
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of Tip Max Distance
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
Change of Tip Max Velocity
Time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
Background: PubMed 25387001Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.
Background: PubMed 29156493Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.
Background: PubMed 30380586Borges LR, Fernandes AB, Melo LP, Guerra RO, Campos TF. Action observation for upper limb rehabilitation after stroke. Cochrane Database Syst Rev. 2018 Oct 31;10(10):CD011887. doi: 10.1002/14651858.CD011887.pub2.
Background: PubMed 28978349Shih TY, Wu CY, Lin KC, Cheng CH, Hsieh YW, Chen CL, Lai CJ, Chen CC. Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial. Trials. 2017 Oct 4;18(1):459. doi: 10.1186/s13063-017-2205-z.
BackgroundKim C-H, Bang D-H. Action observation training enhances upper extremity function in subacute stroke survivor with moderate impairment: a double-blind, randomized controlled pilot trial. J Korean Soc Phys Med. 2016;11(1):133-140. doi:10.13066/kspm.2016.11.1.133
Background: PubMed 22235059Franceschini M, Ceravolo MG, Agosti M, Cavallini P, Bonassi S, Dall'Armi V, Massucci M, Schifini F, Sale P. Clinical relevance of action observation in upper-limb stroke rehabilitation: a possible role in recovery of functional dexterity. A randomized clinical trial. Neurorehabil Neural Repair. 2012 Jun;26(5):456-62. doi: 10.1177/1545968311427406. Epub 2012 Jan 10.
Background: PubMed 20848369Lin KC, Chuang LL, Wu CY, Hsieh YW, Chang WY. Responsiveness and validity of three dexterous function measures in stroke rehabilitation. J Rehabil Res Dev. 2010;47(6):563-71. doi: 10.1682/jrrd.2009.09.0155.
Background: PubMed 27077994Kuk EJ, Kim JM, Oh DW, Hwang HJ. Effects of action observation therapy on hand dexterity and EEG-based cortical activation patterns in patients with post-stroke hemiparesis. Top Stroke Rehabil. 2016 Oct;23(5):318-25. doi: 10.1080/10749357.2016.1157972. Epub 2016 Mar 31.
Background: PubMed 8024419Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.
Background: PubMed 29049194Fu J, Zeng M, Shen F, Cui Y, Zhu M, Gu X, Sun Y. Effects of action observation therapy on upper extremity function, daily activities and motion evoked potential in cerebral infarction patients. Medicine (Baltimore). 2017 Oct;96(42):e8080. doi: 10.1097/MD.0000000000008080.
Background: PubMed 27365261Saposnik G, Cohen LG, Mamdani M, Pooyania S, Ploughman M, Cheung D, Shaw J, Hall J, Nord P, Dukelow S, Nilanont Y, De Los Rios F, Olmos L, Levin M, Teasell R, Cohen A, Thorpe K, Laupacis A, Bayley M; Stroke Outcomes Research Canada. Efficacy and safety of non-immersive virtual reality exercising in stroke rehabilitation (EVREST): a randomised, multicentre, single-blind, controlled trial. Lancet Neurol. 2016 Sep;15(10):1019-27. doi: 10.1016/S1474-4422(16)30121-1. Epub 2016 Jun 27.
Background: PubMed 9341688Dorman PJ, Waddell F, Slattery J, Dennis M, Sandercock P. Is the EuroQol a valid measure of health-related quality of life after stroke? Stroke. 1997 Oct;28(10):1876-82. doi: 10.1161/01.str.28.10.1876.

Related trials for Stroke

Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
Acute Stroke, Upper Limb Motor Deficit

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.

Riccardo Buraschi, DPT principal investigator

IRCCS Fondazione Don Carlo Gnocchi

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality, Action Observation Therapy and Landscape video in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS 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 2 inclusion and 9 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: withdrawn, as of the sponsor's last update on 12 Aug 2024. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.

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 of Upper limb function (time frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04560764, which also lists 15 linked publications.

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 12 Aug 2024.