Virtual Reality in Aphasia Telerehabilitation

NCT ID: NCT04828759

Last Updated: 2021-04-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2025-12-31

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.

Conditions

Aphasia, Acquired

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VR-treatment, then Treatment as usual

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.

Group Type: EXPERIMENTAL

VR-treatment

Intervention Type: BEHAVIORAL

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 usual, then 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.

Group Type: EXPERIMENTAL

Treatment as usual

Intervention Type: BEHAVIORAL

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

Interventions

VR-treatment

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peili Vision Oy

UNKNOWN

Sponsor Role: collaborator

Verve Oulu

UNKNOWN

Sponsor Role: collaborator

City of Oulu

UNKNOWN

Sponsor Role: collaborator

University of Oulu

OTHER

Sponsor Role: lead

Responsible Party

Matti Lehtihalmes

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Matti Lehtihalmes, Professor

Role: CONTACT

matti.lehtihalmes@oulu.fi

+358407024320

Emilia Malinen, MA

Role: CONTACT

emilia.malinen@oulu.fi

+358407194250

Other Identifiers

70/2020

Identifier Type: -

Identifier Source: org_study_id