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Reinforced Feedback in Virtual Environment

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01955291
Acronym
RFVE
Enrollment
136
Registered
2013-10-07
Start date
2008-01-31
Completion date
2015-08-31
Last updated
2016-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Virtual Reality, Motor Learning, Rehabilitation, Upper Limb

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.

Interventions

DEVICEReinforced 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.

OTHERTraditional 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.

Sponsors

IRCCS San Camillo, Venezia, Italy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fugl_Meyer Upper Extremity scale (F-M UE)20 minApplied at the beginning and at the end of treatment 4 weeks thereafter.

Secondary

MeasureTime frameDescription
Functional Independence Measure scale (FIM)20 minAssessed at the beginning and at the end of treatment 4 weeks thereafter.
National Institutes of Health Stroke Scale (NIHSS)5 minAssessed at the beginning and at the end of treatment 4 weeks thereafter.
Kinematic assessment30 minThe 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

MeasureTime frameDescription
Modified Ashworth scale10 minAssessed 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)20 minPerformed at the beginning.
Edmonton Symptom Assessment Scale (ESAS)5 minAssessed at the beginning and at the end of the treatment, 4 weeks thereafter.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026