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Completed

NCT Number: NCT02234531

Comparison Study of 'Virtual Teacher' Support for Rehabilitation After Stroke.

The aim of the project is to assess whether the continuous visualization of on-line teacher in virtual reality (VR) is effective for the improvement of upper limb motor function, in stroke patients.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Camillo IRCCS, Venezia, VE, Italy

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About this study

A single-blind randomized controlled trial (RCT) will be carried out to compare the effects of reinforced feedback in virtual environment (RFVE) treatment with continuous displaying of a virtual teacher (EVER TEACHER group) with RFVE without the presence of a virtual teacher (NEVER TEACHER group).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first single stroke,
  • absence of ideomotor apraxia, neglect, aphasia interfering with verbal comprehension,
  • 0 < NIHSS-IT < 4

Exclusion criteria

  • bilateral or cerebellum stroke,
  • unstable medical conditions,
  • fracture,
  • major depressive disorders,
  • other neurological conditions,
  • epilepsy.

Treatment and study plan

EVER TEACHER

Device

The treatment will be performed in a darkened room, to avoid distraction provided by environmental stimuli. The patients will be seat on a standard chair in front of a wall screen handling a sensorized object with plegic hand. In case of grasping deficits the hand's surface will be used as end effector (i.e. sensorized glove worn by the patient). During the treatment a specific feedback called "virtual teacher" will be displayed. The Reinforced Feedback in Virtual Environment (RFVE) approach consists of performing different motor tasks moving the end effector simultaneously displayed in the virtual scenario. The Virtual Reality Rehabilitation System (VRRS®. Khymeia Group, Noventa Padovana. Italy) will be used as device to provide the artificial environment.

NEVER TEACHER

Device

The patients allocated to NEVER TEACHER group, will be treated using the VRRS and the proceedings will be the same as described for experimental group. In this group, the patient will move the real object (e.g. ball) following the trajectory of the corresponding virtual object displayed on the wall screen in accordance with the requested virtual task and without the 'virtual teacher' support.

Primary outcomes

  1. Fugl-Meyer Upper Extremity scale (FM UE)

    Time frame: Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter)

    Applied at the beginning and at the end of treatment (after 20 sessions).

Secondary outcomes

  1. Fugl-Meyer Assessment - Sensation

    Time frame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)

    Applied at the beginning and at the end of treatment (after 20 sessions).

  2. Fugl-Meyer Assessment - Pain and ROM

    Time frame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)

    Applied at the beginning and at the end of treatment (after 20 sessions).

  3. Reaching Performance Scale

    Time frame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)

    Applied at the beginning and at the end of treatment (after 20 sessions).

  4. Modified Ashworth Scale

    Time frame: Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter)

    Applied at the beginning and at the end of treatment (after 20 sessions).

  5. Functional Independence Measure scale (FIM)

    Time frame: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)

    Applied at the beginning and at the end of treatment (after 20 sessions).

  6. Nine Hole Pegboard Test

    Time frame: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)

    Applied at the beginning and at the end of treatment (after 20 sessions).

Other outcomes

  1. Kinematic Assessment

    Time frame: Change from baseline of the following parameters; speed, time, peak at the end of Virtual therapy (four weeks thereafter)

    The kinematic assessment include the execution of standardised upper limb movements, such as: forearm pronation and supination, elbow flexion and extension, shoulder abduction and adduction, shoulder internal and external rotation, shoulder flexion and extension and reaching movements. The mean linear velocity (Speed), the mean duration of movements (Time) and the mean number of submovements (Peak) will be measured, by means of the Virtual Reality Rehabilitation System (VRRS®. Khymeia Group, Noventa Padovana. Italy). The data will be registered at the beginning and at the end of treatment, 4 weeks thereafter.

Sponsors and collaborators

Lead sponsor

IRCCS San Camillo, Venezia, Italy

Other

Collaborators

  • Ministry of Health, Italy
  • Società Italiana di Fisioterapia (SIF)

Registry information

Official study title

Assessment of a Virtual Teacher Feedback for the Recovery of Upper Limb After Stroke.

Acronym: MAVASI

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2014
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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