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Completed

NCT Number: NCT06200025

Virtual Reality in Aphasia Rehabilitation

Virtual reality-based aphasia rehabilitation has been shown to improve the language skills of individuals with aphasia in the chronic period after stroke. However, non-immersive or semi-immersive rehabilitation methods have often been adopted in the studies. Considering the importance of the visual given to the patient for naming, it can be thought that full immersive therapy may be more effective. Therefore, the aim of this study was to investigate the effect of cue-based aphasia naming therapy in a fully immersive virtual reality environment on aphasia severity and aphasia-related quality of life and to compare it with standard cue treatments.

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Key information

Conditions

Stroke, Ischemic Aphasia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Ischemic Stroke Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Health Sciences Bolu Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosed with non-fluent aphasia by a neurologist
  • at least 4 months after stroke
  • A score of 29 and above on the language score sub-item of the GAT scale

Exclusion criteria

  • severe sensory impairments (vision, hearing) that prevent participation in therapies
  • severe motor dysfunction
  • apraxia
  • neglect
  • dementia
  • psychiatric disorders
  • 3D vision problems

Treatment and study plan

Cue-based speech therapy in virtual reality

Other

Treatment applied with virtual reality headsets to provide 3d visual and auditory cues to individuals in a virtual environment. A treatment environment where the provision of cues can be controlled by the therapist, interacting with 3d clues and receiving feedback on the accuracy of the named objects.

Cue-based speech therapy

Other

Treatment involving the assessment of language skills and the presentation of communication strategies to the individual, including the use of personalized phonological cues.

Primary outcomes

  1. Gülhane Aphasia Test

    Time frame: through study completion, an average of 1 year

    Gülhane Aphasia Test-2 (GAT-2) was used to assess aphasia severity. GAT-2 is a valid and reliable test developed by Maviş et al. to evaluate aphasia and to obtain information about motor speech disorders such as dysarthria and apraxia that may accompany aphasia.

    The GAT-2 consists of 7 subsections: speech fluency, listening comprehension, reading comprehension, oral-motor evaluation, automatic speech, repetition and naming. A maximum total score of 82 can be obtained and higher scores are associated with better speech function.

Secondary outcomes

  1. Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)

    Time frame: through study completion, an average of 1 year

    It is a 39-item valid and reliable scale used to assess quality of life in individuals with aphasia, which examines 4 sub-headings: physical, psychosocial, communication and energy. In 21 items of the scale, the difficulties experienced by individuals with aphasia in their activities in the last week are evaluated, and in the other 18 items, the emotional reactions and possible problems experienced by individuals in the last week are questioned.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

The Virtual Reality Rises; The Fall of The Aphasia

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Jan 10, 2024

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.

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