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Virtual Reality in Aphasia Telerehabilitation

Primary Purpose

Aphasia, Acquired

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VR-treatment
Treatment as usual
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia, Acquired focused on measuring aphasia, virtual reality, head-mounted device, rehabilitation, telerehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    VR-treatment, then Treatment as usual

    Treatment as usual, then VR-treatment

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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 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 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 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 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)

    Secondary Outcome Measures

    Attrition rates during the study.
    Amount of drop outs of participants during the study,
    Participants' experiences of the VR-intervention
    The structural survey of participants' experiences of the VR-intervention.
    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
    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.
    Participants' experiences of the waitlist period
    The structural survey of participants' experiences of the waitlist period

    Full Information

    First Posted
    March 23, 2021
    Last Updated
    March 30, 2021
    Sponsor
    University of Oulu
    Collaborators
    Peili Vision Oy, Verve Oulu, City of Oulu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04828759
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Oulu
    Collaborators
    Peili Vision Oy, Verve Oulu, City of Oulu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aphasia, Acquired
    Keywords
    aphasia, virtual reality, head-mounted device, rehabilitation, telerehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    VR-treatment, then Treatment as usual
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Treatment as usual, then VR-treatment
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    VR-treatment
    Intervention Description
    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
    Intervention Name(s)
    Treatment as usual
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change in language abilities from baseline to week 9 and to week 18
    Description
    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
    Title
    Change in naming abilities from baseline to week 9 and to week 18
    Description
    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
    Title
    Change in verbal fluency from baseline to week 9 and to week 18
    Description
    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
    Title
    Change in functional communication skills from baseline to week 9 and to week 18
    Description
    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
    Title
    Change in quality of life from baseline to week 9 and to week 18
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Attrition rates during the study.
    Description
    Amount of drop outs of participants during the study,
    Time Frame
    Through study completion, up to 18 weeks
    Title
    Participants' experiences of the VR-intervention
    Description
    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
    Title
    Data collected by VR-devices regarding the performance of participants during the VR-intervention
    Description
    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
    Title
    Date collected by remote sessions regarding the experiences of participants and feasibility of VR-intervention
    Description
    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
    Title
    Participants' experiences of the waitlist period
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Matti Lehtihalmes, Professor
    Phone
    +358407024320
    Email
    matti.lehtihalmes@oulu.fi
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emilia Malinen, MA
    Phone
    +358407194250
    Email
    emilia.malinen@oulu.fi

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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