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

August 8, 2024 updated by: Riccardo Buraschi, Fondazione Don Carlo Gnocchi Onlus

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (T0) and at the end of the treatment (T1, after 4 weeks).
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.
Baseline (T0) and at the end of the treatment (T1, after 4 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).
EuroQol-5D questionnaire. This questionnaire measures the quality of life. Range 5-15. Lower values represent a better outcome.
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).
Most difficult level the participant is able to complete, from 1 to 6. Higher values represent a better performance.
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).
Number of tasks the participants performs correctly. Higher values represent a better performance.
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).
Seconds from the appearance of the target to the start of the movement. Lower values represent a better outcome.
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).
Seconds from the appearance of the target to its reaching. Lower values represent a better outcome.
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).
Seconds required for single exercise execution. Lower values represent a better outcome.
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).
Likert 1-5. This scale measures the level of satisfaction of the subject regarding the treatment. Higher values represent a better outcome.
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).
Maximal velocity (meters/seconds) of the hand movement during reaching of the target. Higher values represent a better outcome.
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).
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.
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).
Spectral parameter related to the smoothness of the movement. Negative values lower than -1 stand for lower smoothness.
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).
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.
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).
Maximal distance between the thumb and index fingertips.
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).
Maximal velocity of opening and closing between the thumb and index fingertips.
Baseline (T0) and at the end of the treatment (T1, after 4 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Investigators

  • Principal Investigator: Riccardo Buraschi, DPT, IRCCS Fondazione Don Carlo Gnocchi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2023

Primary Completion (Estimated)

June 1, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

October 2, 2019

First Submitted That Met QC Criteria

September 22, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDG_AOTVR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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