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

Sponsor
University of Alberta (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05897593
Collaborator
Alberta Health services (Other), Mitacs (Industry)
30
1
2
23
1.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: GlenXRose Augmented Reality Acquired Brian Injury Therapies
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
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)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:
Single (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.
Primary Purpose:
Treatment
Official Title:
Clinical Feasibility & Validation of the Augmented Reality-Delivered GlenxRose Programs for Acquired Brain Injury
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
May 31, 2025
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Augmented Reality Delivered Therapy + Standard Clinical Care

The GlenXRose augmented reality therapies will be delivered to participants using a head-mounted device to allow vocal therapy and practice. Participants will also receive routine clinical care provided by speech-language pathologists.

Device: GlenXRose Augmented Reality Acquired Brian Injury Therapies
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.

No Intervention: Standard Clinical Care

Participants will receive routine clinical care provided by clinicians.

Outcome Measures

Primary Outcome Measures

  1. Frequency [Up to 12 Weeks]

    Reported frequency of rehabilitation therapy

  2. Generalization [Up to 12 Weeks]

    Self-reported time of rehabilitation

  3. Compliance Rate [Up to 12 Weeks]

    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)

  4. Adherence - Attendance [Up to 12 Weeks]

    Attendance and Practice Records

  5. Adherence - Self Reported [Up to 12 Weeks]

    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)

  6. Adherence - Clinician Reported [Up to 12 Weeks]

    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

  1. Cognitive Functioning - SCATBI [Up to 12 Weeks]

    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.

  2. Cognitive Functioning - LOTCA [Up to 12 Weeks]

    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.

  3. Cognitive Functioning - Behaviour [Up to 12 Weeks]

    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.

  4. Upper-Limb Motor Coordination [Up to 12 Weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Glenrose Rehabilitation Hospital Edmonton Alberta Canada T5G 0B7

Sponsors and Collaborators

  • University of Alberta
  • Alberta Health services
  • Mitacs

Investigators

  • Study Chair: Jim Raso, MASc, Glenrose Foundation

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University of Alberta
ClinicalTrials.gov Identifier:
NCT05897593
Other Study ID Numbers:
  • Pro00131342
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 9, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Alberta
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2023