An interventional study of VR-treatment and Treatment as usual in Aphasia, Acquired, sponsored by University of Oulu. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-04-02.
Sponsored by University of Oulu · Not applicable, Interventional, and Treatment
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).
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.
365 studies on the registry are indexed under Aphasia; 89 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 316 interventional studies indexed under Aphasia.
Browse Aphasia studies →University of Oulu is the lead sponsor of 138 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: VR-treatment
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.
Behavioral: Treatment as usual
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
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
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change from baseline to week 8 and to week 18
Attrition rates during the study.
Amount of drop outs of participants during the study,
Time frame: Through study completion, up to 18 weeks
Participants' experiences of the VR-intervention
The structural survey of 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
Amounts of training (in minutes) and e.g. naming speed and range of head movements collected automatically by VR-devices
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
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.
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
The structural survey of 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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University of Oulu