Augmented Reality Rehabilitation for Acquired Brain Injury

Overseen By Mathieu Figeys, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Severe ABI, Cognitive disorders, Aphasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how augmented reality (AR) can make rehabilitation more engaging for individuals with acquired brain injuries, such as those from accidents or strokes. By transforming therapy into a fun, game-like experience, the trial aims to improve the frequency and quality of patients' adherence to their rehab routines, potentially leading to better recovery outcomes. Participants will either use the new AR therapy, known as GlenXRose Augmented Reality Acquired Brain Injury Therapies, alongside their usual care or continue with standard care alone. This trial is suitable for adults at Glenrose Rehabilitation Hospital who have mild to moderate brain injuries and can use an AR headset. As an unphased trial, it offers a unique opportunity to explore innovative rehabilitation methods that could enhance the recovery experience.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this augmented reality rehabilitation program is safe for acquired brain injury patients?

Research has shown that GlenXRose's augmented reality therapies are generally easy for patients with brain injuries to handle. This technology uses a headset to make rehabilitation more engaging and enjoyable, helping patients adhere to their treatment plans.

While specific side effects for this therapy are not detailed, augmented reality in rehab is considered safe. The technology aims to enhance traditional care without causing harm. As the program undergoes further study to assess its effectiveness, any risks are not expected to be serious.

Overall, the goal is to make therapy more enjoyable and assist patients in following their treatment plans to improve recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about GlenXRose Augmented Reality Acquired Brain Injury Therapies because they offer a cutting-edge approach to rehabilitation using augmented reality. Unlike traditional therapies that involve standard physical exercises and cognitive activities, this treatment immerses patients in a virtual environment through a head-mounted device, enhancing engagement and motivation. This innovative delivery method not only makes rehabilitation more interactive but also allows for personalized therapy sessions that can be tailored to the specific needs of each patient. By leveraging technology, these therapies aim to improve outcomes and potentially accelerate recovery in ways conventional methods cannot.

What evidence suggests that the GlenXRose AR-delivered ABI program is effective for acquired brain injury rehabilitation?

Research has shown that augmented reality (AR) can aid recovery in people with brain injuries. Studies have found that AR makes therapy more engaging and enjoyable, helping patients adhere to their treatment plans. Staying motivated and consistent with therapy is crucial for recovery. Early results suggest that AR therapies can be tailored to fit individual needs, making them more effective than traditional methods alone. In this trial, participants in one arm will receive the GlenXRose AR program alongside standard clinical care. The GlenXRose AR program aims to improve commitment to therapy and enhance recovery by making it an interactive experience. ^{1 2 4 5 6}

Who Is on the Research Team?

Jim Raso, MASc

Principal Investigator

Glenrose Foundation

Are You a Good Fit for This Trial?

This trial is for adults at the Glenrose Rehabilitation Hospital in Edmonton, Canada with mild to moderate acquired brain injury. Participants must speak English and have enough upper-limb strength and coordination to use an AR headset. It's not for children, those with severe brain injuries or cognitive disorders, severe aphasia, communication disorders that affect understanding verbal commands, previous neurological/psychiatric conditions, substance misuse issues, or impairments limiting interaction with AR.

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

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

Communication disorders that impact comprehension of verbal commands and understanding of scale used in the study

Previous neurological and/or psychiatric disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the GlenXRose augmented reality therapies alongside standard clinical care for acquired brain injury rehabilitation

12 weeks

Regular in-person sessions

Follow-up

Participants are monitored for adherence, cognitive functioning, and motor coordination after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GlenXRose Augmented Reality Acquired Brian Injury Therapies

Trial Overview The study tests augmented reality (AR) therapies called GlenXRose for acquired brain injury rehabilitation. The goal is to see if gamifying therapy through AR can make it more engaging and improve patient adherence compared to traditional methods. This will be assessed alongside routine care while considering clinician feedback and financial costs.

How Is the Trial Designed?

Group I: Augmented Reality Delivered Therapy + Standard Clinical Care Experimental Treatment 1 Intervention

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.

Group II: Standard Clinical Care Active Control 1 Intervention

Participants will receive routine clinical care provided by clinicians.

GlenXRose Augmented Reality Acquired Brian Injury Therapies is already approved in Canada for the following indications:

Approved in Canada as GlenXRose AR-delivered ABI program for:

• Acquired Brain Injury Rehabilitation

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Mitacs

Industry Sponsor

Trials

46

Recruited

5,200+

Published Research Related to This Trial

Innovative technologies using biofeedback for sensorimotor retraining show promise in the rehabilitation of patients who have suffered a cerebral stroke, as supported by high-level evidence from various clinical studies and guidelines.

Multisensory training that engages visual, auditory, vestibular, and kinesthetic systems enhances cognitive-motor training and motivation, suggesting that combining digital technologies with biofeedback and virtual reality can significantly improve rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Innovative technologies and multimodal correction in medical rehabilitation of motor and neuropsychological disturbances due to stroke]. Kostenko, EV., Petrova, LV., Pogonchenkova, IV., et al.[2022]

Extended reality (XR) shows promise in rehabilitation for individuals with acquired brain injury (ABI), potentially leading to faster recovery, shorter hospital stays, and reduced costs, based on a review of 75 studies from 2010 to May 2022.

Most studies focused on virtual reality (VR) for cognitive, physical, and diagnostic therapy, indicating positive outcomes and enthusiasm from both patients and professionals, although XR is not yet common practice in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Extended Reality in Rehabilitation for Patients with Acquired Brain Injury: A Scoping Review. Bulle-Smid, L., Keuning, W., Van Den Heuvel, R., et al.[2023]

Virtual and augmented reality environments are being effectively used for rehabilitation, helping individuals with various impairments, such as balance and attention, especially in children with brain injuries.

The shift from commercial gaming systems to specialized rehabilitation technologies indicates a growing trend in using advanced virtual reality and motion tracking to enhance therapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Rehabilitation with Children: Challenges for Clinical Adoption [From the Field]. Glegg, S.[2018]

A 58-year-old man with right hemiplegia showed significant improvements in gait and lower limb motor function after 8 weeks of VR-based physical therapy combined with traditional therapy, indicating the efficacy of this approach.

The use of VR technology provided real-time feedback that enhanced rehabilitation outcomes, as evidenced by increased step length, stride length, and a rise in the Fugl-Meyer assessment score from 18 to 23 points.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Balance, Gait, and Lower Limb Motor Function in a 58-Year-Old Man with Right Hemiplegic Traumatic Brain Injury Following Virtual Reality-Based Real-Time Feedback Physical Therapy. Kim, KH., Kim, DH.[2023]

The RobExReha system, which combines a robotic arm with augmented reality (AR) gaming, was found to be safe and feasible for neurorehabilitation in 11 adult patients with upper limb impairments, showing no serious adverse events during the study.

While patients rated the usability of the RobExReha system positively, the Reference Group using traditional robotic devices reported higher satisfaction in terms of reliability and ease of use, indicating areas for improvement in the new system's design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic arm training in neurorehabilitation enhanced by augmented reality - a usability and feasibility study. de Crignis, AC., Ruhnau, ST., Hösl, M., et al.[2023]

The study involving 78 patients with brain injury found that immersive virtual reality (VR) training is safe, with no serious adverse events reported, although some patients experienced minor issues like dizziness.

Patients who adhered to the VR training (participating 3 or more times) reported higher satisfaction and perceived effectiveness in their recovery from upper limb paralysis compared to those who participated less frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. Lim, I., Cha, B., Cho, DR., et al.[2023]

Eighteen studies on Augmented Reality (AR) for stroke rehabilitation indicate that while user experiences are generally positive, the technology is still in early development stages and lacks a clear definition, leading to confusion with virtual reality.

Current AR applications primarily focus on rote exercises without occupational relevance, highlighting the need for further research to enhance motor learning and contextual application in rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of augmented reality for rehabilitation after stroke: a narrative review. Gorman, C., Gustafsson, L.[2022]

A novel and affordable augmented reality system, Augmented Reflection Technology (ART), combined with mirror therapy, has been shown to be feasible for clinical use in upper limb rehabilitation for subacute stroke patients.

The integration of ART into rehabilitation protocols can enhance the effectiveness of inpatient therapy, potentially leading to improved recovery outcomes for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised mirror therapy with Augmented Reflection Technology for early stroke rehabilitation: clinical feasibility and integration as an adjunct therapy. Hoermann, S., Ferreira Dos Santos, L., Morkisch, N., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05897593

Clinical Feasibility & Validation of the Augmented Reality ... The GlenXRose augmented reality therapies will be delivered to participants using a head-mounted device to allow acquired brain injury rehabilitation therapy ...

2. withpower.com withpower.com/trial/phase-brain-injuries-9-2023-b664a

Augmented Reality Rehabilitation for Acquired Brain Injury Research suggests that augmented reality (AR) and virtual reality (VR) can help improve rehabilitation outcomes for people with acquired brain injuries by ...

3. clinconnect.io clinconnect.io/trials/NCT05897593

Clinical Feasibility & Validation of the Augmented - ClinConnect This clinical trial is studying a new rehabilitation program using augmented reality (AR) to help patients recover from acquired brain injuries, strokes, or ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37806176/

Challenges and promises of mixed-reality interventions in ... This scoping review aims to explore MR-systems in ABI rehabilitation, while assessing the evidence base and technology readiness levels of these systems.

5. mdpi.com mdpi.com/2077-0383/12/24/7680

Use of Virtual Reality in Patients with Acquired Brain Injury This review will examine the studies in which virtual reality has been used as an aid, technique, or intervention in patients with acquired brain injury.

6. centerwatch.com centerwatch.com/clinical-trials/listings/condition/590/brain-injury?activelyRecruiting=false&page=114

Brain Injury Clinical Research Trials ... ABI therapy can significantly promote clinical/functional outcomes. Purpose & Objective: The GlenXRose Augmented Reality (AR) - ABI program, developed by ...