Clinical trial NCT05897593: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acquired Brain Injury
Stroke
Traumatic Brain Injury
Keywords: Augmented Reality
AR
Virtual Reality
VR
Brain Injury
Stroke
Rehabilitation
Occupational Therapy
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: Mitacs
First posted: 2023-06-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency
timeFrame: Up to 12 Weeks
measure: Generalization
timeFrame: Up to 12 Weeks
measure: Compliance Rate
timeFrame: Up to 12 Weeks
measure: Adherence - Attendance
timeFrame: Up to 12 Weeks
measure: Adherence - Self Reported
timeFrame: Up to 12 Weeks
measure: Adherence - Clinician Reported
timeFrame: Up to 12 Weeks
Secondary outcomes:
measure: Cognitive Functioning - SCATBI
timeFrame: Up to 12 Weeks
measure: Cognitive Functioning - LOTCA
timeFrame: Up to 12 Weeks
measure: Cognitive Functioning - Behaviour
timeFrame: Up to 12 Weeks
measure: Upper-Limb Motor Coordination
timeFrame: Up to 12 Weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation Hospital
state: Alberta
Study officials:
affiliation: Glenrose Foundation
name: Jim Raso, MASc
role: STUDY_CHAIR
References:
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.
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.
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.
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.
citation: Adamovich, B. B., & Henderson, J. Scales of Cognitive Ability for Traumatic Brain Injury (SCATBI). 1992. Chicago, IL: Riverside Publishing.
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.
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.
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.