Virtual Reality in Aphasia Telerehabilitation

NCT04828759 | Unknown

• 1 other identifier: 70/2020
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Aphasia, Acquired

Keywords

aphasia, virtual reality, head-mounted device, rehabilitation, telerehabilitation

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Attrition rates during the study.

  Through study completion, up to 18 weeks

• 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

• Data collected by VR-devices regarding the performance of participants during the VR-intervention

  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

  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

  After waitlist period, at the week 9 or at the week 18, depending of the group the patient has been randomized

Study Arms (2)

VR-treatment, then Treatment as usual

EXPERIMENTAL

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

Treatment as usual, then VR-treatment

EXPERIMENTAL

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

Interventions

VR-treatment 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

VR-treatment, then Treatment as usual

Treatment as usual 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead
• Peili Vision Oy: collaborator
• Verve Oulu: collaborator
• City of Oulu: collaborator

MeSH Terms

Conditions

Aphasia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Matti Lehtihalmes, Professor

CONTACT

+358407024320; matti.lehtihalmes@oulu.fi

Emilia Malinen, MA

CONTACT

+358407194250; emilia.malinen@oulu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 2, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share