Skip to main content
OpenTrials
Completed

NCT Number: NCT01955291

Reinforced Feedback in Virtual Environment

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Ospedale San Camillo IRCCS

Venezia, Veneto, 30126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Virtual Reality Rehabilitation System (VRRS)

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.

Primary outcomes

  1. Fugl_Meyer Upper Extremity scale (F-M UE)

    Time frame: 20 min

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

Secondary outcomes

  1. Functional Independence Measure scale (FIM)

    Time frame: 20 min

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

  2. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: 5 min

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

  3. Kinematic assessment

    Time frame: 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.

Other outcomes

  1. Edmonton Symptom Assessment Scale (ESAS)

    Time frame: 5 min

    Assessed at the beginning and at the end of the treatment, 4 weeks thereafter.

  2. Modified Ashworth scale

    Time frame: 10 min

    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.

  3. Mini Mental State Examination scale (MMSE)

    Time frame: 20 min

    Performed at the beginning.

Sponsors and collaborators

Lead sponsor

IRCCS San Camillo, Venezia, Italy

Other

Registry information

Official study title

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

Acronym: RFVE

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Oct 7, 2013
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.