Reinforced Feedback in Virtual Environment

NCT01955291 | Completed DMC

• 1 other identifier: 02/09 vers. 2.0
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Virtual Reality, Motor Learning, Rehabilitation, Upper Limb

Outcome Measures

Primary Outcomes (1)

• Fugl_Meyer Upper Extremity scale (F-M UE)

  Applied at the beginning and at the end of treatment 4 weeks thereafter.

  20 min

Secondary Outcomes (3)

• Functional Independence Measure scale (FIM)

  20 min

• National Institutes of Health Stroke Scale (NIHSS)

  5 min

• Kinematic assessment

  30 min

Other Outcomes (3)

• Edmonton Symptom Assessment Scale (ESAS)

  5 min

• Modified Ashworth scale

  10 min

• Mini Mental State Examination scale (MMSE)

  20 min

Study Arms (2)

Reinforced Feedback in Virtual Environment

EXPERIMENTAL

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.

Device: Reinforced Feedback in Virtual Environment (RFVE)

Traditional Neromotor Rehabilitation

OTHER

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.

Other: Traditional Neuromotor Rehabilitation

Interventions

Reinforced Feedback in Virtual Environment (RFVE) DEVICE

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.

Also known as: Virtual Reality Rehabilitation System (VRRS)

Reinforced Feedback in Virtual Environment

Traditional Neuromotor Rehabilitation OTHER

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.

Traditional Neromotor Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

Fondazione Ospedale San Camillo IRCCS

Venezia, Veneto, 30126, Italy

Location

Related Publications (3)

• 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.

  PMID: 22713539 BACKGROUND

• 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.

  PMID: 24745024 BACKGROUND

• Kiper P, Szczudlik A, Agostini M, Opara J, Nowobilski R, Ventura L, Tonin P, Turolla A. Virtual Reality for Upper Limb Rehabilitation in Subacute and Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 May;99(5):834-842.e4. doi: 10.1016/j.apmr.2018.01.023. Epub 2018 Feb 14.

  PMID: 29453980 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paolo Tonin, MD

  Fondazione Ospedale San Camillo IRCCS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 7, 2013
• Study Start: January 1, 2008
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

IT (1)