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

NCT05897593 | Not Yet Recruiting

• 1 other identifier: Pro00131342
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury; Stroke; Traumatic Brain Injury

Keywords

Augmented Reality; AR; Virtual Reality; VR; Brain Injury; Stroke; Rehabilitation; Occupational Therapy

Outcome Measures

Primary Outcomes (6)

• Frequency

  Reported frequency of rehabilitation therapy

  Up to 12 Weeks

• Generalization

  Self-reported time of rehabilitation

  Up to 12 Weeks

• 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)

  Up to 12 Weeks

• Adherence - Attendance

  Attendance and Practice Records

  Up to 12 Weeks

• 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)

  Up to 12 Weeks

• 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)

  Up to 12 Weeks

Secondary Outcomes (4)

• Cognitive Functioning - SCATBI

  Up to 12 Weeks

• Cognitive Functioning - LOTCA

  Up to 12 Weeks

• Cognitive Functioning - Behaviour

  Up to 12 Weeks

• Upper-Limb Motor Coordination

  Up to 12 Weeks

Study Arms (2)

Augmented Reality Delivered Therapy + Standard Clinical Care

EXPERIMENTAL

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.

Device: GlenXRose Augmented Reality Acquired Brian Injury Therapies

Standard Clinical Care

NO INTERVENTION

Participants will receive routine clinical care provided by clinicians.

Interventions

GlenXRose Augmented Reality Acquired Brian Injury Therapies DEVICE

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.

Augmented Reality Delivered Therapy + Standard Clinical Care

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator
• Mitacs: collaborator

Study Sites (1)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

Location

Related Publications (8)

• 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.

  PMID: 27965879 BACKGROUND

• 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.

  PMID: 20163979 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31823381 BACKGROUND

• Adamovich, B. B., & Henderson, J. Scales of Cognitive Ability for Traumatic Brain Injury (SCATBI). 1992. Chicago, IL: Riverside Publishing.

  BACKGROUND

• Wilson B, Cockburn J, Halligan P. Development of a behavioral test of visuospatial neglect. Arch Phys Med Rehabil. 1987 Feb;68(2):98-102.

  PMID: 3813864 BACKGROUND

• 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.

  PMID: 3160243 BACKGROUND

• 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.

  PMID: 29496655 RESULT

Related Links

• ELIXR

MeSH Terms

Conditions

Brain Injuries; Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jim Raso, MASc

  Glenrose Foundation

  STUDY CHAIR

Central Study Contacts

Adriana Rios Rincon, PhD, R.OT

CONTACT

780.492.5150; aros@ualberta.ca

Mathieu Figeys, PhD, RN

CONTACT

780.735.6296; figeys@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 9, 2023
• Study Start: October 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)