Trial record 14 of 204 for:    stroke [CONDITION] AND rehabilitation [TREATMENT] | Open Studies

Reinforced Feedback in Virtual Environment (RFVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by IRCCS San Camillo, Venezia, Italy
Sponsor:
Information provided by (Responsible Party):
Pawel Kiper, IRCCS San Camillo, Venezia, Italy
ClinicalTrials.gov Identifier:
NCT01955291
First received: September 27, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Stroke
Device: Reinforced Feedback in Virtual Environment (RFVE)
Other: Traditional Neuromotor Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Virtual Therapy by Means of Reinforced Feedback in Virtual Environment on Upper Limb Function in Post-stroke Patients.

Resource links provided by NLM:


Further study details as provided by IRCCS San Camillo, Venezia, Italy:

Primary Outcome Measures:
  • Fugl_Meyer Upper Extremity scale (F-M UE) [ Time Frame: 20 min ] [ Designated as safety issue: Yes ]
    Applied at the beginning and at the end of treatment 4 weeks thereafter.


Secondary Outcome Measures:
  • Functional Independence Measure scale (FIM) [ Time Frame: 20 min ] [ Designated as safety issue: Yes ]
    Assessed at the beginning and at the end of treatment 4 weeks thereafter.

  • National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: 5 min ] [ Designated as safety issue: Yes ]
    Assessed at the beginning and at the end of treatment 4 weeks thereafter.

  • Kinematic assessment [ Time Frame: 30 min ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: 5 min ] [ Designated as safety issue: Yes ]
    Assessed at the beginning and at the end of the treatment, 4 weeks thereafter.

  • Modified Ashworth scale [ Time Frame: 10 min ] [ Designated as safety issue: Yes ]
    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.

  • Mini Mental State Examination scale (MMSE) [ Time Frame: 20 min ] [ Designated as safety issue: Yes ]
    Performed at the beginning.


Estimated Enrollment: 136
Study Start Date: January 2008
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reinforced Feedback in Virtual Environment
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)
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 Name: Virtual Reality Rehabilitation System (VRRS)
Traditional Neromotor 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01955291

Contacts
Contact: Pawel Kiper, PhD 00390412207 ext 214 pawel.kiper@ospedalesancamillo.net
Contact: Andrea Turolla, MSc 00390412207 ext 531 andrea.turolla@ospedalesancamillo.net

Locations
Italy
Fondazione Ospedale San Camillo IRCCS Recruiting
Venezia, Veneto, Italy, 30126
Contact: Andrea Turolla, MSc    00390412207 ext 531    andrea.turolla@ospedalesancamillo.net   
Principal Investigator: Pawel Kiper, PhD         
Sponsors and Collaborators
IRCCS San Camillo, Venezia, Italy
Investigators
Study Director: Paolo Tonin, MD Fondazione Ospedale San Camillo IRCCS
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pawel Kiper, PhD, IRCCS San Camillo, Venezia, Italy
ClinicalTrials.gov Identifier: NCT01955291     History of Changes
Other Study ID Numbers: 02/09 vers. 2.0
Study First Received: September 27, 2013
Last Updated: October 8, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS San Camillo, Venezia, Italy:
Virtual Reality, Motor Learning, Rehabilitation, Upper Limb

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 27, 2014