Motor Performance Improvement After Visual Rehabilitation

NCT06698172 | Recruiting DMC

• 1 other identifier: VRvisualfield
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Visual Field Loss; Balance; Brain Injury; Motor Performance

Outcome Measures

Primary Outcomes (2)

• Visual field

  The threshold test will be used in a 30-2 field size with fixation monitoring.

  15 minutes

• 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.

  15 minutes

Secondary Outcomes (16)

• Visual Acuity

  2 minutes

• Subjective refraction

  5 minutes

• Worth test

  1 minute

• Ramdom Dot 2

  2 minutes

• Cover Test

  1 minute

Study Arms (1)

VR Study Group

EXPERIMENTAL

Once the patient is included in the study, 12 weekly sessions of visual rehabilitation, each lasting 45 minutes, will be scheduled. A Virtual Reality device will be used along with the Visionary Sport visual therapy software.

Other: Virtual Reality rehabilitation

Interventions

Virtual Reality rehabilitation OTHER

The 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.

VR Study Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects with more than 6 months of progression since the brain injury.
• Subjects who have an electronic device such as a computer and internet access to perform the exercises at home.
• Subjects with altitudinal visual field loss, hemianopia, or quadrantanopia with the central field preserved and at least 0.5 visual acuity.

You may not qualify if:

• 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.
• Subjects with previous ocular surgery (cataract or refractive surgery) with less than 6 months of progression.
• Subjects who are not stable in any associated clinical pathology or otherwise diagnosed.
• Subjects who have previously undergone visual rehabilitation for the field defect.
• Not performing the proposed home exercises.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (2)

University of Zaragoza

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

University of Zaragoza

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Maria José López de la Fuente, PhD

  Universidad de Zaragoza

  STUDY CHAIR

• Jorge Pérez Rey, PhD

  Universidad de Zaragoza

  STUDY CHAIR

• Naiara Díaz Marín, MSc

  Universidad de Zaragoza

  STUDY CHAIR

• Javier Mateo Gabás, PhD

  Universidad de Zaragoza

  STUDY CHAIR

Central Study Contacts

Carmen López de la Fuente, PhD

CONTACT

(+34)667218052; carmenlf@unizar.es

Yolanda Marcén Román, PhD

CONTACT

(+34)630637923; yomarcen@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. from the University of Zaragoza

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 20, 2024
• Study Start: November 29, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)