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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment GlenXRose Augmented Reality Acquired Brain Injury Therapies?

Research suggests that augmented reality (AR) and virtual reality (VR) can help improve rehabilitation outcomes for people with acquired brain injuries by enhancing physical therapy, improving motor function, and reducing the need for professional supervision. For example, a case study showed that a man with a brain injury improved his walking and leg movement after using VR-based therapy. ^{1 2 3 4 5}

Is augmented reality rehabilitation safe for people with acquired brain injury?

Research on immersive virtual reality, which is similar to augmented reality, shows it is generally safe for brain injury rehabilitation, with no serious adverse events reported. Some patients experienced mild dizziness, but overall satisfaction was moderate, and the treatment was considered safe. ^{1 2 4 6 7}

How is the GlenXRose Augmented Reality Acquired Brain Injury Therapies treatment different from other treatments for acquired brain injury?

The GlenXRose Augmented Reality Acquired Brain Injury Therapies treatment is unique because it uses augmented reality (AR) technology to enhance rehabilitation, potentially reducing the need for professional supervision and speeding up recovery. This approach integrates advanced digital technologies to provide multisensory experiences that can improve cognitive and motor skills, making it a novel option compared to traditional rehabilitation methods. ^{1 2 3 4 8}

Research Team

Jim Raso, MASc

Principal Investigator

Glenrose Foundation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The Use of Extended Reality in Rehabilitation for Patients with Acquired Brain Injury: A Scoping Review. [2023]

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Innovative technologies and multimodal correction in medical rehabilitation of motor and neuropsychological disturbances due to stroke]. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The use of augmented reality for rehabilitation after stroke: a narrative review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Robotic arm training in neurorehabilitation enhanced by augmented reality - a usability and feasibility study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Computerised mirror therapy with Augmented Reflection Technology for early stroke rehabilitation: clinical feasibility and integration as an adjunct therapy. [2022]