Aphasia, AcquiredNCT04828759
Virtual Reality in Aphasia Telerehabilitation
A study testing VR-treatment and Treatment as usual in people with Aphasia, Acquired, run by University of Oulu.
Trial summary
The main purpose of this study is to evaluate the use of the immersive 3D HMD VR technology in the language intervention with a home-based telerehabilitation approach for people with aphasia. The assessments will be conducted at the baseline (prior the intervention periods) and after each intervention period (i.e. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aphasia, Acquired
- What is being tested?
- VR-treatment and Treatment as usual
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 31 Dec 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-stroke aphasia ≥ 3 months from stroke
- Age 18-75 years
- Finnish as a native language
- Relative have the motivation and willingness to support person with aphasia in rehabilitation process
- At least some level of spoken output
- Moderate-to-severe aphasia
- Deficit in a word retrieval process
Who cannot join
- Participation in other intervention study during the study
- Participation in other traditional speech and language therapy during the VR-intervention (i.e. 9-10 weeks period).
- Severe and current psychotic disorder
- Dementia/other neurodegenerative disease
- History of previous stroke (/strokes) if not recovered, excluding TIAs (the criteria for the recovery: no residual aphasia or other disabilities caused by stroke which would affect in significant manner on everyday life)
- Active epilepsy / migraine (< 3 years)
Show all 12Show fewer
- Severe apraxia of speech
- Inability to act according to given instruction
- Severe neuropsychological disorder or the decline of cognitive / memory functions, which would significantly affect for training during the VR-intervention
- Vision or hearing impairment which would prevent the use of VR HMD
- if the participant's treatment or medication is unsuitable with the use of VR HMD device as assessed by the physician
- if the participant has the pacemaker or implantable (electric) medical device
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Combining Immersive Virtual Reality With Telerehabilitation to Provide Language Intervention for People With Aphasia: A Randomized Waitlist Controlled Trial
The main purpose of this study is to evaluate the use of the immersive 3D HMD VR technology in the language intervention with a home-based telerehabilitation approach for people with aphasia. The assessments will be conducted at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period).
Read the detailed description
The purpose of the present project is to study the effects, feasibility, and the participants' experiences of this novel kind of language intervention. The effects of the intervention will be studied with various outcome measures in terms of language performance, functional communication, and quality of life. The aim is to explore the VR-intervention on the group level and with a randomized waitlist control group design (or delayed crossover design). In this study, the people with aphasia will be practicing at their home with support of their relatives, and participants will also receive regular remote guidance by a speech and language therapist (SLT) during the intervention. The relatives are also involved in the assessment process.
- Conditions
- Aphasia, Acquired
- Being tested
- VR-treatment, Treatment as usual
- Keywords
- aphasia, virtual reality, head-mounted device, rehabilitation, telerehabilitation
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-treatmentBehavioural
The participants will be randomized either to group which receives the VR-intervention immediately (A) or to the waitlist control group (B). After the baseline assessment, the participants in the group A participate VR-intervention lasting for 8 weeks, and the participants in the group B will receive 8 weeks waitlist period. After the 8 weeks, the groups switch their places
Treatment as usualBehavioural
The participants will be randomized either to group which receives the VR-intervention immediately (A) or to the waitlist control group (B). After the baseline assessment, the participants in the group A participate VR-intervention lasting for 8 weeks, and the participants in the group B will receive 8 weeks waitlist period. After the 8 weeks, the groups switch their places
| Study group | Role | What they receive |
|---|---|---|
| VR-treatment, then Treatment as usual | Experimental | Participants will receive 8 weeks of VR-treatment. Participants are allowed to practice as much as they wish during the VR-intervention. However, they are given a recommendation of the amount of practice (5 h / week). Before the VR-intervention, the participants will receive a guidance for using the VR-devices (i.e. orientation period) by the SLT. Participants will be able to contact the SLT freely during the 8 weeks VR-intervention period. After the orientation period, the participants will be practicing at their homes independently. However, they will receive remote guidance by the SLT. The guidance includes weekly remote guidance sessions by SLT (8 x 45 min) to ensure that training is fluent and unproblematic. Additionally, the content of exercises can be modified during these sessions. The SLT is also able to monitor the training of participants with the system. Devices: VR headset and controller, Tablet computer. Receives: Behavioral: VR-treatment |
| Treatment as usual, then VR-treatment | Experimental | Wait list control group: During the waitlist period the participants will receive the traditional speech and language therapy rehabilitation offered by (if offered) the general health care system in their own home municipality. The amount of rehabilitation is not controlled during the wait list period. However, the amount of received traditional speech and language rehabilitation in waitlist period will be documented. The waitlist control group will receive the same VR intervention period after the 8 weeks waitlist period. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in language abilities from baseline to week 9 and to week 18
Language abilities are assessed using language quotient LQ score of Western Aphasia Battery (WAB), performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Measured: Change from baseline to week 9 and to week 18
Change in naming abilities from baseline to week 9 and to week 18
Naming abilities for nouns and verbs are assessed with Boston Naming Test (BNT) and TNT-test (action naming test in Finnish) performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Measured: Change from baseline to week 9 and to week 18
Change in verbal fluency from baseline to week 9 and to week 18
Verbal fluency is assessed using multiple categories (produced words per one minute in each category), performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Measured: Change from baseline to week 9 and to week 18
Change in functional communication skills from baseline to week 9 and to week 18
Functional communication skills are assessed with Communication Effectiveness Index (CETI), performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Measured: Change from baseline to week 9 and to week 18
Change in quality of life from baseline to week 9 and to week 18
Quality of life is assessed with Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39), performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Measured: Change from baseline to week 8 and to week 18
Secondary outcomes (5)
Attrition rates during the study.
Amount of drop outs of participants during the study,
Measured: Through study completion, up to 18 weeks
Participants' experiences of the VR-intervention
The structural survey of participants' experiences of the VR-intervention.
Measured: After VR-intervention period, at the week 9 or at the week 18, depending of the group the patient has been randomized
Data collected by VR-devices regarding the performance of participants during the VR-intervention
Amounts of training (in minutes) and e.g. naming speed and range of head movements collected automatically by VR-devices
Measured: Through the VR-intervention up to 8 weeks or through the weeks 10-17, depending of the group the patient has been randomized
Date collected by remote sessions regarding the experiences of participants and feasibility of VR-intervention
Data collected with semi-structural interview during remote guidance sessions (8 times during the VR-period) by the researcher. In addition, participants will be able to contact the researcher freely during the 8 weeks VR-intervention period.
Measured: Weekly during the VR-intervention up to 8 weeks or through the weeks 10-17, depending of the group the patient has been randomized
Participants' experiences of the waitlist period
The structural survey of participants' experiences of the waitlist period
Measured: After waitlist period, at the week 9 or at the week 18, depending of the group the patient has been randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Apr 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphasia, AcquiredStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Peili Vision Oy, Verve Oulu, City of Oulu
- Responsible party
- Principal investigator, Matti Lehtihalmes, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828759
- Sponsor's protocol ID
- 70/2020
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 2 Apr 2021
- 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 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Immersive Virtual Reality With Telerehabilitation to Provide Language Intervention for People With Aphasia: A Randomized Waitlist Controlled Trial
- ClinicalTrials.gov ID
- NCT04828759
- Acronym / sponsor ID
- 70/2020
- Conditions
- Aphasia, Acquired
- Keywords
- aphasia, virtual reality, head-mounted device, rehabilitation, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Peili Vision Oy, Verve Oulu, City of Oulu
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Apr 2021 (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.
The main purpose of this study is to evaluate the use of the immersive 3D HMD VR technology in the language intervention with a home-based telerehabilitation approach for people with aphasia. The assessments will be conducted at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period).
Detailed description
The purpose of the present project is to study the effects, feasibility, and the participants' experiences of this novel kind of language intervention. The effects of the intervention will be studied with various outcome measures in terms of language performance, functional communication, and quality of life. The aim is to explore the VR-intervention on the group level and with a randomized waitlist control group design (or delayed crossover design). In this study, the people with aphasia will be practicing at their home with support of their relatives, and participants will also receive regular remote guidance by a speech and language therapist (SLT) during the intervention. The relatives are also involved in the assessment process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-treatment, then Treatment as usual | Experimental | Behavioral: VR-treatmentParticipants will receive 8 weeks of VR-treatment. Participants are allowed to practice as much as they wish during the VR-intervention. However, they are given a recommendation of the amount of practice (5 h / week). Before the VR-intervention, the participants will receive a guidance for using the VR-devices (i.e. orientation period) by the SLT. Participants will be able to contact the SLT freely during the 8 weeks VR-intervention period. After the orientation period, the participants will be practicing at their homes independently. However, they will receive remote guidance by the SLT. The guidance includes weekly remote guidance sessions by SLT (8 x 45 min) to ensure that training is fluent and unproblematic. Additionally, the content of exercises can be modified during these sessions. The SLT is also able to monitor the training of participants with the system. Devices: VR headset and controller, Tablet computer. |
| Treatment as usual, then VR-treatment | Experimental | Behavioral: Treatment as usualWait list control group: During the waitlist period the participants will receive the traditional speech and language therapy rehabilitation offered by (if offered) the general health care system in their own home municipality. The amount of rehabilitation is not controlled during the wait list period. However, the amount of received traditional speech and language rehabilitation in waitlist period will be documented. The waitlist control group will receive the same VR intervention period after the 8 weeks waitlist period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Post-stroke aphasia ≥ 3 months from stroke
- Age 18-75 years
- Finnish as a native language
- Relative have the motivation and willingness to support person with aphasia in rehabilitation process
- At least some level of spoken output
Key exclusion criteria (12 listed)
- Participation in other intervention study during the study
- Participation in other traditional speech and language therapy during the VR-intervention (i.e. 9-10 weeks period).
- Severe and current psychotic disorder
- Dementia/other neurodegenerative disease
- History of previous stroke (/strokes) if not recovered, excluding TIAs (the criteria for the recovery: no residual aphasia or other disabilities caused by stroke which would affect in significant manner on everyday life)
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 |
|---|---|---|
| VR-treatmentThe participants will be randomized either to group which receives the VR-intervention immediately (A) or to the waitlist control group (B). After the baseline assessment, the participants in the group A participate VR-intervention lasting for 8 weeks, and the participants in the group B will receive 8 weeks waitlist period. After the 8 weeks, the groups switch their places | Behavioural | VR-treatment, then Treatment as usual |
| Treatment as usualThe participants will be randomized either to group which receives the VR-intervention immediately (A) or to the waitlist control group (B). After the baseline assessment, the participants in the group A participate VR-intervention lasting for 8 weeks, and the participants in the group B will receive 8 weeks waitlist period. After the 8 weeks, the groups switch their places | Behavioural | Treatment as usual, then VR-treatment |
Primary outcome
Change in language abilities from baseline to week 9 and to week 18
Time frame: Change from baseline to week 9 and to week 18
Language abilities are assessed using language quotient LQ score of Western Aphasia Battery (WAB), performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Change in naming abilities from baseline to week 9 and to week 18
Time frame: Change from baseline to week 9 and to week 18
Naming abilities for nouns and verbs are assessed with Boston Naming Test (BNT) and TNT-test (action naming test in Finnish) performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Change in verbal fluency from baseline to week 9 and to week 18
Time frame: Change from baseline to week 9 and to week 18
Verbal fluency is assessed using multiple categories (produced words per one minute in each category), performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Change in functional communication skills from baseline to week 9 and to week 18
Time frame: Change from baseline to week 9 and to week 18
Functional communication skills are assessed with Communication Effectiveness Index (CETI), performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Change in quality of life from baseline to week 9 and to week 18
Time frame: Change from baseline to week 8 and to week 18
Quality of life is assessed with Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39), performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
5 secondary outcomes
Attrition rates during the study.
Time frame: Through study completion, up to 18 weeks
Participants' experiences of the VR-intervention
Time frame: After VR-intervention period, at the week 9 or at the week 18, depending of the group the patient has been randomized
Data collected by VR-devices regarding the performance of participants during the VR-intervention
Time frame: Through the VR-intervention up to 8 weeks or through the weeks 10-17, depending of the group the patient has been randomized
Date collected by remote sessions regarding the experiences of participants and feasibility of VR-intervention
Time frame: Weekly during the VR-intervention up to 8 weeks or through the weeks 10-17, depending of the group the patient has been randomized
Participants' experiences of the waitlist period
Time frame: After waitlist period, at the week 9 or at the week 18, depending of the group the patient has been randomized
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing VR-treatment and Treatment as usual in people with Aphasia, Acquired, run by University of Oulu.
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 7 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matti Lehtihalmes, Professor (+358407024320, matti.lehtihalmes@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in language abilities from baseline to week 9 and to week 18 (time frame: Change from baseline to week 9 and to week 18). The study lists 5 primary outcomes in all. 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 2 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.