Stroke, IschemicNCT06200025
Virtual Reality in Aphasia Rehabilitation
A study testing Cue-based speech therapy in virtual reality and Cue-based speech therapy in people with Stroke, Ischemic and Aphasia, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic, Aphasia
- What is being tested?
- Cue-based speech therapy in virtual reality and Cue-based speech therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe sensory impairments (vision, hearing) that prevent participation in therapies
- severe motor dysfunction
- apraxia
- neglect
- dementia
- psychiatric disorders
- 3D vision problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences Bolu Abant Izzet Baysal University
Bolu, Merkez, 14100
About this study
Official title: The Virtual Reality Rises; The Fall of The Aphasia
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
- Being tested
- Cue-based speech therapy in virtual reality, Cue-based speech therapy
- Medical subject headings
- Ischemic Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue-based speech therapy in virtual realityOther
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 therapyOther
Treatment involving the assessment of language skills and the presentation of communication strategies to the individual, including the use of personalized phonological cues.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | visual and auditory cue-based aphasia rehabilitation program in full immersive virtual reality Receives: Other: Cue-based speech therapy in virtual reality |
| Conventional Group | Active comparator | visual and auditory cue-based aphasia rehabilitation program Receives: Other: Cue-based speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start15 Oct 2021
- Primary completion1 Jul 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups with a conventional control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- Ramazan Kurul, Ph.D, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200025
- Sponsor's protocol ID
- AIBU-FTR-BENLI-006
- Status last verified
- Dec 2023
- First submitted
- 29 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Virtual Reality Rises; The Fall of The Aphasia
- ClinicalTrials.gov ID
- NCT06200025
- Acronym / sponsor ID
- AIBU-FTR-BENLI-006
- Conditions
- Stroke, Ischemic, Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two groups with a conventional control group
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Cue-based speech therapy in virtual realityvisual and auditory cue-based aphasia rehabilitation program in full immersive virtual reality |
| Conventional Group | Active comparator | Other: Cue-based speech therapyvisual and auditory cue-based aphasia rehabilitation program |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- severe sensory impairments (vision, hearing) that prevent participation in therapies
- severe motor dysfunction
- apraxia
- neglect
- dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cue-based speech therapy in virtual realityTreatment 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. | Other | Virtual Reality Group |
| Cue-based speech therapyTreatment involving the assessment of language skills and the presentation of communication strategies to the individual, including the use of personalized phonological cues. | Other | Conventional Group |
Primary outcome
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.
1 secondary outcome
Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39)
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramazan Kurul, Ph.D principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cue-based speech therapy in virtual reality and Cue-based speech therapy in people with Stroke, Ischemic and Aphasia, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gülhane Aphasia Test (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.