Reinforced Feedback in Virtual Environment

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Traditional Neuromotor Rehabilitation; Device: Reinforced Feedback in Virtual Environment (RFVE)

• Registration Number: NCT01955291
• Lead Sponsor: IRCCS San Camillo, Venezia, Italy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2013-09-27
• Study First Submitted QC: 2013-09-27
• Study First Posted: 2013-10-07
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-31
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Neromotor Rehabilitation	Traditional Neuromotor Rehabilitation	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.
Reinforced Feedback in Virtual Environment	Reinforced Feedback in Virtual Environment (RFVE)	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.

Primary Outcome Measures

Name	Time	Method
Fugl_Meyer Upper Extremity scale (F-M UE)	20 min	Applied at the beginning and at the end of treatment 4 weeks thereafter.

Secondary Outcome Measures

Name	Time	Method
Functional Independence Measure scale (FIM)	20 min	Assessed at the beginning and at the end of treatment 4 weeks thereafter.
National Institutes of Health Stroke Scale (NIHSS)	5 min	Assessed at the beginning and at the end of treatment 4 weeks thereafter.
Kinematic assessment	30 min	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). The data will be registered at the beginning and at the end of treatment, 4 weeks thereafter.

Trial Locations

Locations (1)

Fondazione Ospedale San Camillo IRCCS; 🇮🇹 Venezia, Veneto, Italy