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Reinforced Feedback in Virtual Environment (RFVE)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Reinforced Feedback in Virtual Environment (RFVE)
Traditional Neuromotor Rehabilitation
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Virtual Reality, Motor Learning, Rehabilitation, Upper Limb

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Fondazione Ospedale San Camillo IRCCS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Reinforced Feedback in Virtual Environment

Traditional Neromotor Rehabilitation

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional Independence Measure scale (FIM)
Assessed at the beginning and at the end of treatment 4 weeks thereafter.
National Institutes of Health Stroke Scale (NIHSS)
Assessed at the beginning and at the end of treatment 4 weeks thereafter.
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.

Full Information

First Posted
September 27, 2013
Last Updated
August 31, 2016
Sponsor
IRCCS San Camillo, Venezia, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01955291
Brief Title
Reinforced Feedback in Virtual Environment
Acronym
RFVE
Official Title
The Role of Virtual Therapy by Means of Reinforced Feedback in Virtual Environment on Upper Limb Function in Post-stroke Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Virtual Reality, Motor Learning, Rehabilitation, Upper Limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reinforced Feedback in Virtual Environment
Arm Type
Experimental
Arm 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.
Arm Title
Traditional Neromotor Rehabilitation
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Reinforced Feedback in Virtual Environment (RFVE)
Other Intervention Name(s)
Virtual Reality Rehabilitation System (VRRS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional Neuromotor Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl_Meyer Upper Extremity scale (F-M UE)
Description
Applied at the beginning and at the end of treatment 4 weeks thereafter.
Time Frame
20 min
Secondary Outcome Measure Information:
Title
Functional Independence Measure scale (FIM)
Description
Assessed at the beginning and at the end of treatment 4 weeks thereafter.
Time Frame
20 min
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
Assessed at the beginning and at the end of treatment 4 weeks thereafter.
Time Frame
5 min
Title
Kinematic assessment
Description
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.
Time Frame
30 min
Other Pre-specified Outcome Measures:
Title
Edmonton Symptom Assessment Scale (ESAS)
Description
Assessed at the beginning and at the end of the treatment, 4 weeks thereafter.
Time Frame
5 min
Title
Modified Ashworth scale
Description
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.
Time Frame
10 min
Title
Mini Mental State Examination scale (MMSE)
Description
Performed at the beginning.
Time Frame
20 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Tonin, MD
Organizational Affiliation
Fondazione Ospedale San Camillo IRCCS
Official's Role
Study Director
Facility Information:
Facility Name
Fondazione Ospedale San Camillo IRCCS
City
Venezia
State/Province
Veneto
ZIP/Postal Code
30126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22713539
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.
Results Reference
background
PubMed Identifier
24745024
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.
Results Reference
background
PubMed Identifier
29453980
Citation
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.
Results Reference
derived

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Reinforced Feedback in Virtual Environment

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