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

IRCCS San Camillo, Venezia, Italy

Status: Completed

Conditions: Stroke

Treatments: Device: EVER TEACHER; Device: NEVER TEACHER

Study type: Interventional

Funder types: Other

Identifiers

NCT02234531

Protocollo 2013.11

Details and patient eligibility

About

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.

Full 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).

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

EVER TEACHER

Experimental group

Description:

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.

Treatment:

Device: EVER TEACHER

NEVER TEACHER

Other group

Description:

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.

Treatment:

Device: NEVER TEACHER