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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04560764
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Riccardo Buraschi, Fondazione Don Carlo Gnocchi Onlus

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Stroke Device: Virtual Reality Device: Action Observation Therapy Device: Landscape video Other: Standard treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Reality and Action-Observation Therapy: An Integrated Approach Supported by Novel Technologies for Upper Limb Impairment in Subacute Stroke
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Virtual Reality + Action Observation Therapy
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.
Device: Virtual Reality

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.


Device: Action Observation Therapy
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.

Other: Standard treatment
Participants in both groups will receive the standard treatment, one hour a day for three days a week.

Sham Comparator: Virtual Reality + Landscape video
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.
Device: Virtual Reality

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.


Device: Landscape video
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.

Other: Standard treatment
Participants in both groups will receive the standard treatment, one hour a day for three days a week.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change of autonomy [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    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.

  2. Change of quality of Life [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    EuroQol-5D questionnaire. This questionnaire measures the quality of life. Range 5-15. Lower values represent a better outcome.

  3. Change of level completed [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    Most difficult level the participant is able to complete, from 1 to 6. Higher values represent a better performance.

  4. Change of number of correct tasks [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    Number of tasks the participants performs correctly. Higher values represent a better performance.

  5. Change of reaction time [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    Seconds from the appearance of the target to the start of the movement. Lower values represent a better outcome.

  6. Change of interaction time [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    Seconds from the appearance of the target to its reaching. Lower values represent a better outcome.

  7. Change of mean time of exercise execution [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    Seconds required for single exercise execution. Lower values represent a better outcome.

  8. Level of Satisfaction [ Time Frame: At the end of the treatment (4 weeks). ]
    Likert 1-5. This scale measures the level of satisfaction of the subject regarding the treatment. Higher values represent a better outcome.

  9. Change of Hand Max Reaching Velocity [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    Maximal velocity (meters/seconds) of the hand movement during reaching of the target. Higher values represent a better outcome.

  10. Change of % Cycle Hand Max Velocity [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    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.

  11. Change of Mean SPARC [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    Spectral parameter related to the smoothness of the movement. Negative values lower than -1 stand for lower smoothness.

  12. Change of Mean Reach Path Ratio [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    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.

  13. Change of Tip Max Distance [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    Maximal distance between the thumb and index fingertips.

  14. Change of Tip Max Velocity [ Time Frame: Baseline (T0) and at the end of the treatment (T1, after 4 weeks). ]
    Maximal velocity of opening and closing between the thumb and index fingertips.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560764


Contacts
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Contact: Riccardo Buraschi, DPT 0039 3496657892 rburaschi@gmail.com

Locations
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Italy
Fondazione Don Carlo Gnocchi Onlus - Centro Ettore Spalenza Recruiting
Rovato, Brescia, Italy, 25038
Contact: Riccardo Buraschi, DPT       rburaschi@gmail.com   
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Investigators
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Principal Investigator: Riccardo Buraschi, DPT IRCCS Fondazione Don Carlo Gnocchi
Publications:
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

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Responsible Party: Riccardo Buraschi, Principal investigator, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT04560764    
Other Study ID Numbers: FDG_AOTVR
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riccardo Buraschi, Fondazione Don Carlo Gnocchi Onlus:
Upper limb impairment
Virtual Reality
Action Observation Therapy
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases