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

Stroke Clinical Trial

— MAVASI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234531
• Other study ID #: Protocollo 2013.11
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: June 2021

Study information

• Verified date: June 2022
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• EVER TEACHER
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
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.

Locations

Country	Name	City	State
Italy	San Camillo IRCCS	Venezia	VE
Italy	Azienda ULSS 3 Serenissima	Venice

Sponsors (3)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy	Ministry of Health, Italy, Società Italiana di Fisioterapia (SIF)

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Kinematic Assessment	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.	Change from baseline of the following parameters; speed, time, peak at the end of Virtual therapy (four weeks thereafter)
Primary	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	Fugl-Meyer Assessment - Sensation	Applied at the beginning and at the end of treatment (after 20 sessions).	Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Secondary	Fugl-Meyer Assessment - Pain and ROM	Applied at the beginning and at the end of treatment (after 20 sessions).	Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Secondary	Reaching Performance Scale	Applied at the beginning and at the end of treatment (after 20 sessions).	Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
Secondary	Modified Ashworth Scale	Applied at the beginning and at the end of treatment (after 20 sessions).	Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter)
Secondary	Functional Independence Measure scale (FIM)	Applied at the beginning and at the end of treatment (after 20 sessions).	Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
Secondary	Nine Hole Pegboard Test	Applied at the beginning and at the end of treatment (after 20 sessions).	Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)

External Links

•   Italian Society for Physiotherapy (Società Italiana di Fisioterapia)