Virtual Reality in Aphasia Telerehabilitation

Aphasia, Acquired Clinical Trial

Official title:

Combining Immersive Virtual Reality With Telerehabilitation to Provide Language Intervention for People With Aphasia: A Randomized Waitlist Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04828759
• Other study ID #: 70/2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2021
• Source: University of Oulu
• Contact: Matti Lehtihalmes, Professor
• Phone: +358407024320
• Email: matti.lehtihalmes[@]oulu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. after the VR-intervention period and the waitlist period).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Acquired

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Oulu	City of Oulu, Peili Vision Oy, Verve Oulu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Change from baseline to week 9 and to week 18
Primary	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)	Change from baseline to week 9 and to week 18
Primary	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)	Change from baseline to week 9 and to week 18
Primary	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)	Change from baseline to week 9 and to week 18
Primary	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)	Change from baseline to week 8 and to week 18
Secondary	Attrition rates during the study.	Amount of drop outs of participants during the study,	Through study completion, up to 18 weeks
Secondary	Participants' experiences of the VR-intervention	The structural survey of participants' experiences of the VR-intervention.	After VR-intervention period, at the week 9 or at the week 18, depending of the group the patient has been randomized
Secondary	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	Through the VR-intervention up to 8 weeks or through the weeks 10-17, depending of the group the patient has been randomized
Secondary	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.	Weekly during the VR-intervention up to 8 weeks or through the weeks 10-17, depending of the group the patient has been randomized
Secondary	Participants' experiences of the waitlist period	The structural survey of participants' experiences of the waitlist period	After waitlist period, at the week 9 or at the week 18, depending of the group the patient has been randomized