Motor Performance Improvement After Visual Rehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstituto de Investigación Sanitaria Aragón
About this trial
Acquired brain injury" refers to brain damage that impacts neurological processing, making daily activities challenging and often causing vision issues like binocular dysfunction, oculomotor problems, and visual field loss. In Spain, visual rehabilitation is limited, although it is more common in other countries.
These patients generally need an interdisciplinary approach involving professionals like physiotherapists and optometrists and often face mobility, balance, and spatial perception difficulties. Treatment tools include lenses, prisms, and technologies like virtual reality (VR). The Visionary VR program, presented by Dr. Portela, has shown promising results in visual field recovery by stimulating the affected area.
Visual rehabilitation is based on brain plasticity and involves three key strategies:
Prisms to expand the visual field. Compensatory therapy to improve eye movement. Restitution therapy to restore the visual field.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult subjects diagnosed with acquired brain injury either from a stroke or trauma.
Subjects without cognitive impairment.
Subjects without pre-existing musculoskeletal disorders prior to the acquired brain injury.
Subjects without hemineglect.
Disqualifiers
Not signing the informed consent.
Previous severe mental pathology to eliminate possible confounding factors if their daily activities are already affected.
Uncontrolled epilepsy.
Subjects with glaucoma or retinal pathologies affecting the visual field.
Trial design
Design model
Single group
Treatments tested in this trial
Virtual Reality rehabilitation
Other interventionThe study includes 12 weekly 45-minute visual rehabilitation sessions using a Virtual Reality device with Visionary Sport software. Originally designed for sports visual training, this software features gamified exercises to improve visual response times under professional supervision. Activities include games to enhance fixation, ocular motility, peripheral vision, and vergence. The "Peripheral Attention" activity trains reaction times to static stimuli perceived in the peripheral retina, adjustable to the patient's visual field defect. Stimuli can be placed at 10, 20, or 30 degrees in the peripheral field. The VR headset (Vive Focus 3) includes an eye tracker to monitor and adapt stimuli based on patient performance. Patients also perform 30 minutes of daily exercises at home, using proprietary software and Tobii 4C and 5C eye-tracking devices for ocular monitoring.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: VR Study GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Visual field
The threshold test will be used in a 30-2 field size with fixation monitoring.
Time frame
15 minutes2
Balance
The stabilometric study will be conducted using the Podoprint® pressure platform (Grupo Namrol, Barcelona, Spain). A balance assessment will be conducted after 6 sessions and after 12 sessions of treatment.
Time frame
15 minutesSecondary outcomes
1
Visual Acuity
Measurement of visual acuity in near and distance vision
Time frame
2 minutes2
Subjective refraction
Evaluation of subjective refraction using trial lenses
Time frame
5 minutes3
Worth test
The Worth Four Light Test is a clinical assessment of binocular vision, evaluating diplopia and suppression. The patient views a flashlight with four illuminated dots in a diamond pattern: one red at the top, two green on the sides, and one white at the bottom. The test is conducted at both 40 cm and 6 m distances.
Time frame
1 minute4
Ramdom Dot 2
This test is used to measure the patient's stereopsis between 900" and 12.5".
Time frame
2 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Instituto de Investigación Sanitaria Aragón
Lead sponsor
Universidad de Zaragoza
Sponsor institution
Source ClinicalTrials.gov