Virtual Reality in Aphasia Telerehabilitation

University of Oulu20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aphasia, Acquired

Interventions

VR-treatmentBEHAVIORAL

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 usualBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Central Contacts

Matti Lehtihalmes, Professor

CONTACT

+358407024320 matti.lehtihalmes@oulu.fi

Emilia Malinen, MA

CONTACT

+358407194250 emilia.malinen@oulu.fi

Data from ClinicalTrials.gov

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Secondary Outcomes

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