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Clinical Feasibility & Validation of the Augmented Reality GlenxRose Acquired Brain Injury Rehabilitation Programs

Primary Purpose

Acquired Brain Injury, Stroke, Traumatic Brain Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
GlenXRose Augmented Reality Acquired Brian Injury Therapies
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury focused on measuring Augmented Reality, AR, Virtual Reality, VR, Brain Injury, Stroke, Rehabilitation, Occupational Therapy

Eligibility Criteria

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

Inclusion Criteria: Adults receiving care at the Glenrose Rehabilitation Hospital (Edmonton, Canada) for mild to moderate Acquired Brain Injury Proficiency in English Adequate upper-limb strength and coordination to utilize AR headset (determined by clinicians) Exclusion Criteria: Pediatric populations Severe acquired brain injury severe cognitive and behavioural disorders (e.g. agitation, confusion, aggressive behaviour), which is Level V or higher on the Rancho Los Amigos Levels of Cognitive Functioning Scale Severe aphasia, impacting language comprehension Communication disorders that impact comprehension of verbal commands and understanding of scale used in the study Previous neurological and/or psychiatric disorders Substance misuse disorders Previously acquired brain injury Impairments that limit the interaction with the AR device

Sites / Locations

  • Glenrose Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Augmented Reality Delivered Therapy + Standard Clinical Care

Standard Clinical Care

Arm Description

The GlenXRose augmented reality therapies will be delivered to participants using a head-mounted device to allow acquired brain injury rehabilitation therapy and practice. Participants will also receive routine clinical care provided by clinicians.

Participants will receive routine clinical care provided by clinicians.

Outcomes

Primary Outcome Measures

Frequency
Reported frequency of rehabilitation therapy
Generalization
Self-reported time of rehabilitation
Compliance Rate
Self-reported compliance using a 10cm visual analog scale. Participants mark along the scale where they believe their compliance rate is (0 meaning absolute no compliance, and 10 indicative of perfect compliance to the protocol)
Adherence - Attendance
Attendance and Practice Records
Adherence - Self Reported
Medical Adherence Report Scale (Chan et al., 2020) taken at each in-person session. Higher scores are indicative of stronger adherence and beliefs. (10 items, each scaled between 1-5 on a likert scale)
Adherence - Clinician Reported
Sport Injury Rehabilitation Adherence Scale (Kolt et al., 2006), taken at each in-person session. Higher scores are indicative of greater effort and adherence in the session. (Range 0-15)

Secondary Outcome Measures

Cognitive Functioning - SCATBI
Scale of Cognitive Ability for Traumatic Brain Injury (SCATBI; Adamovich & Henderson, 1992). The SCATBI assesses 5 domains. The interpretation of lower and higher scores on the Scales of Cognitive Ability for Traumatic Brain Injury (SCATBI) depends on the specific subtest being administered. In general, higher scores on cognitive subtests indicate better performance or higher levels of cognitive ability in the specific domain being assessed. Lower scores, on the other hand, may indicate difficulties or impairment in that particular cognitive domain.
Cognitive Functioning - LOTCA
Lowenstein Occupational Therapy Cognitive Assessment. 26 subtests are scored on a scale between 1-4 (1 being poor performance, 4 being optimal performance). higher scores on the LOTCA indicate better cognitive function within a specific domain, while lower scores suggest potential difficulties or impairments in that cognitive area.
Cognitive Functioning - Behaviour
Behavioural Inattention Test (Wilson, Cockburn, & Halligan, 1987). Scoring typically involves comparing the individual's performance to established norms or comparison groups. Higher scores indicate less severe neglect or inattention, while lower scores suggest more pronounced impairments.
Upper-Limb Motor Coordination
Box and Block Test (Mathiowetz, Volland, Kashman, & Weber, 1975). The score is the total number of blocks transferred successfully within the designated time, which is usually one minute. The range of scores on the BBT can vary widely, depending on the individual's abilities and impairments. Higher scores indicate better manual dexterity and motor function, while lower scores suggest limitations or difficulties in performing the task.

Full Information

First Posted
May 18, 2023
Last Updated
June 16, 2023
Sponsor
University of Alberta
Collaborators
Alberta Health services, Mitacs
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1. Study Identification

Unique Protocol Identification Number
NCT05897593
Brief Title
Clinical Feasibility & Validation of the Augmented Reality GlenxRose Acquired Brain Injury Rehabilitation Programs
Official Title
Clinical Feasibility & Validation of the Augmented Reality-Delivered GlenxRose Programs for Acquired Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Alberta Health services, Mitacs

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
Factors related to successful rehabilitation in acquired brain injury (ABI) are often directly related to adherence; for instance, dosage, frequency, and intensity can burden the patient regarding time and motivational factors. Regarding salience, patients may lose interest or find a traditional intervention boring after a few sessions. It is well documented that nonadherence not only impacts rehabilitation for patients but can also further prolong treatment, and increase hospital and clinician costs, in addition to a higher prevalence of future comorbidities. Additionally, the same factors that are related to can impact adherence are also related to neuroplasticity. Therefore, strategies that improve patient adherence can significantly help optimize patient care and treatment outcomes for those with ABI. The gamification of rehabilitation therapies using augmented reality (AR) may help promote adherence. Gamification of rehabilitation therapy can make mass practice required in rehabilitation therapies seemingly fun and more personally engaging for the patient. Additionally, the experience achieved through AR can further promote salience and be customizable to individual patient requirements. As AR systems are now highly portable, cost-effective, and relatively simple to utilize, they can provide an excellent opportunity to provide more engaging rehabilitation approaches compared to standard care alone. AR gamification of rehabilitation may increase adherence by shifting patients' perspectives of therapy as tedious, boring, or a hassle, to a fun and engaging game that ultimately helps their recovery processes. The GlenXRose AR-delivered ABI program (developed by the Cognitive Projections Lab, University of Alberta) has been created in collaboration with the Glenrose Rehabilitation Hospital with the overall goal of increasing patient adherence, treatment outcomes, and satisfaction with ABI rehabilitation therapy. The proposed studies are to investigate the feasibility of implementing this technology alongside routine clinical care, obtaining clinician feedback, examining associated financial costs, and continuing to examine the effect of the GlenXRose AR ABI-therapies on patient adherence and clinical outcomes, compared to traditional clinical care alone.
Detailed Description
Nonadherence to Acquired Brain Injury (ABI) rehabilitation can result in suboptimal recovery or compensation methods while impacting the quality of life and further burdening the healthcare system. In addition to traditional ABI rehabilitation therapy, many patients are given daily exercises to practice and perform. However, it is estimated that up to 50% of patients are non-adherent to rehabilitation (Argent et al., 2018); with such a large prevalence, opportunities to prevent and mitigate nonadherence to ABI therapy can significantly promote clinical/functional outcomes. Purpose & Objective: The GlenXRose Augmented Reality (AR) - ABI program, developed by the Cognitive Projections lab at the University of Alberta in collaboration with the Glenrose Rehabilitation Hospital, provides patients with gamified ABI therapies delivered through immersive AR. The objective of these studies is to examine the feasibility of implementing the previously developed GlenXRose AR-ABI therapies to routine clinical care delivered by Occupational Therapists to patients with an ABI etiology (such as stroke and traumatic brain injury). Variables of patient adherence to treatment as well as preliminary effects on cognition, motor coordination, engagement, and system usability will be explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury, Stroke, Traumatic Brain Injury
Keywords
Augmented Reality, AR, Virtual Reality, VR, Brain Injury, Stroke, Rehabilitation, Occupational Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Study 1: Single-Subject Experimental Design Studies will be Implemented (A-B Design) Study 2: Qualitative Interviews regarding technology acceptance Study 3: Feasibility randomized controlled trial (control and intervention groups)
Masking
Outcomes Assessor
Masking Description
The outcomes assessor will be masked to group allocation (AR-delivered therapy + standard care, or traditional standard care alone). Participants will be asked not to reveal details of the group allocation prior to assessments.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Augmented Reality Delivered Therapy + Standard Clinical Care
Arm Type
Experimental
Arm Description
The GlenXRose augmented reality therapies will be delivered to participants using a head-mounted device to allow acquired brain injury rehabilitation therapy and practice. Participants will also receive routine clinical care provided by clinicians.
Arm Title
Standard Clinical Care
Arm Type
No Intervention
Arm Description
Participants will receive routine clinical care provided by clinicians.
Intervention Type
Device
Intervention Name(s)
GlenXRose Augmented Reality Acquired Brian Injury Therapies
Intervention Description
Rehabilitation therapies for ABI have been developed for augmented reality implementation. These include various games to interact within an augmented environment while conducting rehabilitation therapy.
Primary Outcome Measure Information:
Title
Frequency
Description
Reported frequency of rehabilitation therapy
Time Frame
Up to 12 Weeks
Title
Generalization
Description
Self-reported time of rehabilitation
Time Frame
Up to 12 Weeks
Title
Compliance Rate
Description
Self-reported compliance using a 10cm visual analog scale. Participants mark along the scale where they believe their compliance rate is (0 meaning absolute no compliance, and 10 indicative of perfect compliance to the protocol)
Time Frame
Up to 12 Weeks
Title
Adherence - Attendance
Description
Attendance and Practice Records
Time Frame
Up to 12 Weeks
Title
Adherence - Self Reported
Description
Medical Adherence Report Scale (Chan et al., 2020) taken at each in-person session. Higher scores are indicative of stronger adherence and beliefs. (10 items, each scaled between 1-5 on a likert scale)
Time Frame
Up to 12 Weeks
Title
Adherence - Clinician Reported
Description
Sport Injury Rehabilitation Adherence Scale (Kolt et al., 2006), taken at each in-person session. Higher scores are indicative of greater effort and adherence in the session. (Range 0-15)
Time Frame
Up to 12 Weeks
Secondary Outcome Measure Information:
Title
Cognitive Functioning - SCATBI
Description
Scale of Cognitive Ability for Traumatic Brain Injury (SCATBI; Adamovich & Henderson, 1992). The SCATBI assesses 5 domains. The interpretation of lower and higher scores on the Scales of Cognitive Ability for Traumatic Brain Injury (SCATBI) depends on the specific subtest being administered. In general, higher scores on cognitive subtests indicate better performance or higher levels of cognitive ability in the specific domain being assessed. Lower scores, on the other hand, may indicate difficulties or impairment in that particular cognitive domain.
Time Frame
Up to 12 Weeks
Title
Cognitive Functioning - LOTCA
Description
Lowenstein Occupational Therapy Cognitive Assessment. 26 subtests are scored on a scale between 1-4 (1 being poor performance, 4 being optimal performance). higher scores on the LOTCA indicate better cognitive function within a specific domain, while lower scores suggest potential difficulties or impairments in that cognitive area.
Time Frame
Up to 12 Weeks
Title
Cognitive Functioning - Behaviour
Description
Behavioural Inattention Test (Wilson, Cockburn, & Halligan, 1987). Scoring typically involves comparing the individual's performance to established norms or comparison groups. Higher scores indicate less severe neglect or inattention, while lower scores suggest more pronounced impairments.
Time Frame
Up to 12 Weeks
Title
Upper-Limb Motor Coordination
Description
Box and Block Test (Mathiowetz, Volland, Kashman, & Weber, 1975). The score is the total number of blocks transferred successfully within the designated time, which is usually one minute. The range of scores on the BBT can vary widely, depending on the individual's abilities and impairments. Higher scores indicate better manual dexterity and motor function, while lower scores suggest limitations or difficulties in performing the task.
Time Frame
Up to 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults receiving care at the Glenrose Rehabilitation Hospital (Edmonton, Canada) for mild to moderate Acquired Brain Injury Proficiency in English Adequate upper-limb strength and coordination to utilize AR headset (determined by clinicians) Exclusion Criteria: Pediatric populations Severe acquired brain injury severe cognitive and behavioural disorders (e.g. agitation, confusion, aggressive behaviour), which is Level V or higher on the Rancho Los Amigos Levels of Cognitive Functioning Scale Severe aphasia, impacting language comprehension Communication disorders that impact comprehension of verbal commands and understanding of scale used in the study Previous neurological and/or psychiatric disorders Substance misuse disorders Previously acquired brain injury Impairments that limit the interaction with the AR device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana Rios Rincon, PhD, R.OT
Phone
780.492.5150
Email
aros@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mathieu Figeys, PhD, RN
Phone
780.735.6296
Email
figeys@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Raso, MASc
Organizational Affiliation
Glenrose Foundation
Official's Role
Study Chair
Facility Information:
Facility Name
Glenrose Rehabilitation Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Raso, MASc
Phone
7807357964
Email
james.raso@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Mathieu Figeys, PhD, RN
Phone
780.735.6296
Email
figeys@ualberta.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27965879
Citation
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
Results Reference
background
PubMed Identifier
20163979
Citation
Jack K, McLean SM, Moffett JK, Gardiner E. Barriers to treatment adherence in physiotherapy outpatient clinics: a systematic review. Man Ther. 2010 Jun;15(3):220-8. doi: 10.1016/j.math.2009.12.004. Epub 2010 Feb 16.
Results Reference
background
Citation
Kolt, G.S., et al. The Sport Injury Rehabilitation Adherence Scale: a reliable scale for use in clinical physiotherapy.Physiotherapy. 2007; 93(1): 7-22.
Results Reference
background
PubMed Identifier
31823381
Citation
Chan AHY, Horne R, Hankins M, Chisari C. The Medication Adherence Report Scale: A measurement tool for eliciting patients' reports of nonadherence. Br J Clin Pharmacol. 2020 Jul;86(7):1281-1288. doi: 10.1111/bcp.14193. Epub 2020 May 18.
Results Reference
background
Citation
Adamovich, B. B., & Henderson, J. Scales of Cognitive Ability for Traumatic Brain Injury (SCATBI). 1992. Chicago, IL: Riverside Publishing.
Results Reference
background
PubMed Identifier
3813864
Citation
Wilson B, Cockburn J, Halligan P. Development of a behavioral test of visuospatial neglect. Arch Phys Med Rehabil. 1987 Feb;68(2):98-102.
Results Reference
background
PubMed Identifier
3160243
Citation
Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.
Results Reference
background
PubMed Identifier
29496655
Citation
Argent R, Daly A, Caulfield B. Patient Involvement With Home-Based Exercise Programs: Can Connected Health Interventions Influence Adherence? JMIR Mhealth Uhealth. 2018 Mar 1;6(3):e47. doi: 10.2196/mhealth.8518.
Results Reference
result
Links:
URL
https://www.ualberta.ca/rehabilitation/research/rehabilitation-robotics/current-projects/cogpro-virtual-reality.html
Description
Cognitive Projections Laboratory, University of Alberta

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Clinical Feasibility & Validation of the Augmented Reality GlenxRose Acquired Brain Injury Rehabilitation Programs

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