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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06200025
Other study ID # AIBU-FTR-BENLI-006
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2021
Est. completion date September 15, 2023

Study information

Verified date December 2023
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date September 15, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cue-based speech therapy in virtual reality
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
Treatment involving the assessment of language skills and the presentation of communication strategies to the individual, including the use of personalized phonological cues.

Locations

Country Name City State
Turkey Faculty of Health Sciences Bolu Abant Izzet Baysal University Bolu Merkez

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mavis 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 Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39) 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. through study completion, an average of 1 year
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