Reinforced Feedback in Virtual Environment (RFVE)

IRCCS San Camillo, Venezia, Italy

Status: Completed

Conditions: Stroke

Treatments: Device: Reinforced Feedback in Virtual Environment (RFVE); Other: Traditional Neuromotor Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01955291

02/09 vers. 2.0

Details and patient eligibility

About

The aims of the study is to explore whether the rehabilitation of the upper extremity performed in interaction with a virtual environment could improve motor function in post-ischemic and post-haemorrhagic stroke subjects with hemiparesis, in comparison to the traditional neuromotor rehabilitation treatment.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients affected by a stroke occurring in the period no longer than 1 year before the enrolment
• both first ischemic and hemorrhagic stroke
• subjects who did not had RFVE treatment previously
• scoring higher than 24 points in the Mini-Mental State Examination test

Exclusion criteria

• upper extremity complete hemiplegia
• upper limbs sensory disorders
• clinical evidence of cognitive impairment
• neglect
• apraxia
• comprehension difficulties
• post-traumatic injury of the upper limb

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Reinforced Feedback in Virtual Environment

Experimental group

Description:

During the experiment, patients in the RFVE training group (Reinforced Feedback in Virtual Environment) will receive 1 hour of virtual reality-based therapy by means of RFVE and 1 hour of TNR treatment (Traditional Neuromotor Rehabilitation). Both treatments will last 1 hour a day, five days weekly for four weeks. The treatment is focused on motor function impairment of the upper extremity.

Treatment:

Device: Reinforced Feedback in Virtual Environment (RFVE)

Traditional Neromotor Rehabilitation

Other group

Description:

The TNR training group (Traditional Neuromotor Rehabilitation) patients will be treated totally for two hours daily by means of a TNR programme. The treatment will last 4 weeks.

Treatment:

Other: Traditional Neuromotor Rehabilitation