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

NCT02234531 | Completed DMC

• 1 other identifier: Protocollo 2013.11
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke

Keywords

Virtual Reality,; Enhanced Feedback,; Stroke,; Rehabilitation,; Motor Learning

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Extremity scale (FM UE)

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

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

Secondary Outcomes (6)

• Fugl-Meyer Assessment - Sensation

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

• Fugl-Meyer Assessment - Pain and ROM

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

• Reaching Performance Scale

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

• Modified Ashworth Scale

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

• Functional Independence Measure scale (FIM)

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

Other Outcomes (1)

• Kinematic Assessment

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

Study Arms (2)

EVER TEACHER

EXPERIMENTAL

In EVER TEACHER group a specific feedback called "virtual teacher" will be displayed. The virtual teacher perform the correct movement to emulate, that is supposed to stimulate the motor adaptation exploiting a supervised learning mechanism. This feedback will give an on-line information on motor performance quality, allowing a real time visual comparison between patient's own execution and teacher one. During the experiment, patients will receive 1 hour of virtual reality-based therapy and the treatment will last 1 hour a day, five days weekly for four weeks.

Device: EVER TEACHER

NEVER TEACHER

OTHER

In NEVER TEACHER group the subjects will be asked to perform the same exercises with the upper limb without the virtual teacher assistance. The treatment will last four weeks with daily sessions of 60 minutes, five times per week.

Device: NEVER TEACHER

Interventions

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.

EVER TEACHER

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.

NEVER TEACHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead
• Società Italiana di Fisioterapia (SIF): collaborator
• Ministry of Health, Italy: collaborator

Study Sites (2)

San Camillo IRCCS

Venezia, VE, 30126, Italy

Location

Azienda ULSS 3 Serenissima

Venice, 30126, Italy

Location

Related Publications (3)

• Turolla A, Dam M, Ventura L, Tonin P, Agostini M, Zucconi C, Kiper P, Cagnin A, Piron L. Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial. J Neuroeng Rehabil. 2013 Aug 1;10:85. doi: 10.1186/1743-0003-10-85.

  PMID: 23914733 BACKGROUND

• Kiper P, Agostini M, Luque-Moreno C, Tonin P, Turolla A. Reinforced feedback in virtual environment for rehabilitation of upper extremity dysfunction after stroke: preliminary data from a randomized controlled trial. Biomed Res Int. 2014;2014:752128. doi: 10.1155/2014/752128. Epub 2014 Mar 13.

  PMID: 24745024 BACKGROUND

• Zucconi C, Valt V, Agostini M, Turolla A, Tonin P, Piron L. Assessment of a virtual teacher feedback for the recovery of the upper limb after stroke. Italian Journal of Physiotherapy 2011;1(4):101-6.

  BACKGROUND

Related Links

• Italian Society for Physiotherapy (Società Italiana di Fisioterapia)

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea Turolla, PhD

  San Camillo IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Single blind randomized controlled trial (RCT)

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 9, 2014
• Study Start: April 1, 2013
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

IT (2)