Virtual Reality in Aphasia Rehabilitation

NCT06200025 | Completed

• 1 other identifier: AIBU-FTR-BENLI-006
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Ischemic; Aphasia

Outcome Measures

Primary Outcomes (1)

• Gülhane Aphasia Test

  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.

  through study completion, an average of 1 year

Secondary Outcomes (1)

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

  through study completion, an average of 1 year

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

visual and auditory cue-based aphasia rehabilitation program in full immersive virtual reality

Other: Cue-based speech therapy in virtual reality

Conventional Group

ACTIVE COMPARATOR

visual and auditory cue-based aphasia rehabilitation program

Other: Cue-based speech therapy

Interventions

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.

Virtual Reality Group

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.

Conventional Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Faculty of Health Sciences Bolu Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ischemic Stroke; Aphasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Ramazan Kurul, Ph.D

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: two groups with a conventional control group

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 10, 2024
• Study Start: October 15, 2021
• Primary Completion: July 1, 2023
• Study Completion: September 15, 2023
• Last Updated: January 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)