Reinforced Feedback in Virtual Environment

Stroke Clinical Trial

— RFVE  

Official title:

The Role of Virtual Therapy by Means of Reinforced Feedback in Virtual Environment on Upper Limb Function in Post-stroke Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01955291
• Other study ID #: 02/09 vers. 2.0
• Status: Completed
• Phase: N/A
• First received: September 27, 2013
• Last updated: August 31, 2016
• Start date: January 2008
• Est. completion date: August 2015

Study information

• Verified date: August 2016
• Source: IRCCS San Camillo, Venezia, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Reinforced Feedback in Virtual Environment (RFVE)
The patients allocated to RFVE group, will be treated using the "Virtual Reality Rehabilitation System" (VRRS). During the virtual therapy the subject will be seated in front of the wall screen grasping a sensorized real object with the affected hand. If the grasp is not possible the sensors will be fixed on a glove worn by the patient. The real object held by the subject, equipped with electromagnetic sensors, is matched to the virtual handling object. Thereafter, the patient moved the real object (e.g. ball) following the trajectory of the corresponding virtual object displayed on the computer screen in accordance with the requested virtual task.

Other:
• Traditional Neuromotor Rehabilitation
The patients randomized to the Traditional Neuromotor Rehabilitation group will be asked to perform exercises for postural control, exercises for hand pre-configuration, exercises for the stimulation of manipulation and functional skills, exercises for proximal-distal coordination. All the exercises will be performed with or without the assistance of a physiotherapist. The upper limb motricity will be trained with progressive complexity. To achieve the requested goal (in a horizontal or vertical plane) patients will be asked to perform various movements, for example: shoulder flexion and extension, shoulder abduction and adduction, shoulder internal and external rotation and shoulder circumduction, elbow flexion and extension, forearm pronation and supination, hand grasping-release and clenching into a fist.

Locations

Country	Name	City	State
Italy	Fondazione Ospedale San Camillo IRCCS	Venezia	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Camillo, Venezia, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

Laver K, George S, Thomas S, Deutsch JE, Crotty M. Cochrane review: virtual reality for stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Sep;48(3):523-30. Epub 2012 Jun 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Edmonton Symptom Assessment Scale (ESAS)	Assessed at the beginning and at the end of the treatment, 4 weeks thereafter.	5 min	Yes
Other	Modified Ashworth scale	Assessed at the beginning and at the end of the treatment, 4 weeks thereafter. The scale consist of evaluation of 5 muscles; pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus.	10 min	Yes
Other	Mini Mental State Examination scale (MMSE)	Performed at the beginning.	20 min	Yes
Primary	Fugl_Meyer Upper Extremity scale (F-M UE)	Applied at the beginning and at the end of treatment 4 weeks thereafter.	20 min	Yes
Secondary	Functional Independence Measure scale (FIM)	Assessed at the beginning and at the end of treatment 4 weeks thereafter.	20 min	Yes
Secondary	National Institutes of Health Stroke Scale (NIHSS)	Assessed at the beginning and at the end of treatment 4 weeks thereafter.	5 min	Yes
Secondary	Kinematic assessment	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.	30 min	Yes