Clinical trial NCT04828759: Virtual Reality in Aphasia Telerehabilitation
Official title: Combining Immersive Virtual Reality With Telerehabilitation to Provide Language Intervention for People With Aphasia: A Randomized Waitlist Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aphasia, Acquired
Keywords: aphasia, virtual reality, head-mounted device, rehabilitation, telerehabilitation
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Peili Vision Oy
name: Verve Oulu
name: City of Oulu
First posted: 2021-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Change in language abilities from baseline to week 9 and to week 18
timeFrame: Change from baseline to week 9 and to week 18
measure: Change in naming abilities from baseline to week 9 and to week 18
timeFrame: Change from baseline to week 9 and to week 18
measure: Change in verbal fluency from baseline to week 9 and to week 18
timeFrame: Change from baseline to week 9 and to week 18
measure: Change in functional communication skills from baseline to week 9 and to week 18
timeFrame: Change from baseline to week 9 and to week 18
measure: Change in quality of life from baseline to week 9 and to week 18
timeFrame: Change from baseline to week 8 and to week 18
Secondary outcomes:
measure: Attrition rates during the study.
timeFrame: Through study completion, up to 18 weeks
measure: Participants' experiences of the VR-intervention
timeFrame: After VR-intervention period, at the week 9 or at the week 18, depending of the group the patient has been randomized
measure: Data collected by VR-devices regarding the performance of participants during the VR-intervention
timeFrame: Through the VR-intervention up to 8 weeks or through the weeks 10-17, depending of the group the patient has been randomized
measure: Date collected by remote sessions regarding the experiences of participants and feasibility of VR-intervention
timeFrame: Weekly during the VR-intervention up to 8 weeks or through the weeks 10-17, depending of the group the patient has been randomized
measure: Participants' experiences of the waitlist period
timeFrame: After waitlist period, at the week 9 or at the week 18, depending of the group the patient has been randomized
Other outcomes:
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