Clinical trial NCT02234531: Comparison Study of 'Virtual Teacher' Support for Rehabilitation After Stroke.
Official title: Assessment of a Virtual Teacher Feedback for the Recovery of Upper Limb After Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Virtual Reality,
Enhanced Feedback,
Stroke,
Rehabilitation,
Motor Learning
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
Collaborators: name: Società Italiana di Fisioterapia (SIF)
name: Ministry of Health, Italy
First posted: 2014-09-09
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blind randomized controlled trial (RCT)
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Upper Extremity scale (FM UE)
timeFrame: Change from baseline FM UE scale at the end of Virtual therapy (four weeks thereafter)
Secondary outcomes:
measure: Fugl-Meyer Assessment - Sensation
timeFrame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
measure: Fugl-Meyer Assessment - Pain and ROM
timeFrame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
measure: Reaching Performance Scale
timeFrame: Change from baseline of the Reaching Performance scale at the end of Virtual therapy (four weeks thereafter)
measure: Modified Ashworth Scale
timeFrame: Change from baseline of the Modified Ashworth scale at the end of Virtual therapy (four weeks thereafter)
measure: Functional Independence Measure scale (FIM)
timeFrame: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
measure: Nine Hole Pegboard Test
timeFrame: Change from baseline of the Functional Independence Measure scale at the end of Virtual therapy (four weeks thereafter)
Other outcomes:
measure: Kinematic Assessment
timeFrame: Change from baseline of the following parameters; speed, time, peak at the end of Virtual therapy (four weeks thereafter)
Locations:
city: Venezia
country: Italy
facility: San Camillo IRCCS
state: VE
city: Venice
country: Italy
facility: Azienda ULSS 3 Serenissima
Study officials:
affiliation: San Camillo IRCCS
name: Andrea Turolla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.