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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: NEVER TEACHER; Device: EVER TEACHER

• Registration Number: NCT02234531
• Lead Sponsor: IRCCS San Camillo, Venezia, Italy

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.

Detailed 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).

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-09
• Primary Completion: 2021-06
• Study Completion: 2021-06
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NEVER TEACHER	NEVER TEACHER	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.
EVER TEACHER	EVER TEACHER	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.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Upper Extremity scale (FM UE)	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 Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment - Sensation	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).
Fugl-Meyer Assessment - Pain and ROM	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).
Modified Ashworth Scale	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).
Functional Independence Measure scale (FIM)	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).
Nine Hole Pegboard Test	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).
Reaching Performance Scale	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).

Trial Locations

Locations (2)

San Camillo IRCCS; 🇮🇹 Venezia, VE, Italy

Azienda ULSS 3 Serenissima; 🇮🇹 Venice, Italy