- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06200025
Virtual Reality in Aphasia Rehabilitation
The Virtual Reality Rises; The Fall of The Aphasia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
-
Bolu, Merkez, Turkey, 14100
- Faculty of Health Sciences Bolu Abant Izzet Baysal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Group
visual and auditory cue-based aphasia rehabilitation program in full immersive 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.
|
|
Active Comparator: Conventional Group
visual and auditory cue-based aphasia rehabilitation program
|
Treatment involving the assessment of language skills and the presentation of communication strategies to the individual, including the use of personalized phonological cues.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ramazan Kurul, Ph.D, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-BENLI-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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