~9 spots leftby May 2025

Augmented Reality Rehabilitation for Acquired Brain Injury

Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alberta
Disqualifiers: Severe ABI, Cognitive disorders, Aphasia, others
No Placebo Group
Approved in 1 Jurisdiction

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.

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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.

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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.

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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
+6 more

Trial 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

Participant Groups

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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Augmented Reality Delivered Therapy + Standard Clinical CareExperimental Treatment1 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 CareActive Control1 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

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Glenrose Rehabilitation HospitalEdmonton, Canada
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Who Is Running the Clinical Trial?

University of AlbertaLead Sponsor
Alberta Health servicesCollaborator
MitacsIndustry Sponsor

References

The Use of Extended Reality in Rehabilitation for Patients with Acquired Brain Injury: A Scoping Review. [2023]Extended reality (XR) seems promising for rehabilitation for people with acquired brain injury in terms of reducing professional supervision, faster recovery, shorter hospital stays, and reduced expenses. Since there is no overview this scoping review describes how XR can be utilized in rehabilitation, particularly for people with acquired brain injury (ABI).
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]The article presents an overview of innovative technologies based on the methods of sensorimotor retraining of the patient using various types of biofeedback (BFB) as the most promising in the medical rehabilitation (MR) of patients with cerebral stroke (CS). The works of a high level of evidence (RCTs, national and international clinical guidelines, meta-analyses, systematic reviews) of the Medline, Pubmed, PubMed Cochrane Library databases are analyzed, ClinicalTrials.gov. It is emphasized that training with multisensory effects on visual, auditory, vestibular and kinesthetic analyzers have a beneficial effect on cognitive-motor training and retraining, neuropsychological status of the patient and increase the level of motivation to achieve success in the rehabilitation process. The synergy of multimodal effects of digital technologies, BFB, virtual reality, and the brain-computer interface will expand the capabilities and improve the efficiency of MR of after stroke-patients.
The use of augmented reality for rehabilitation after stroke: a narrative review. [2022]To explore research relating to the use of Augmented Reality (AR) technology for rehabilitation after stroke in order to better understand the current, and potential future application of this technology to enhance stroke rehabilitation.
Virtual Rehabilitation with Children: Challenges for Clinical Adoption [From the Field]. [2018]Virtual, augmented, and mixed reality environments are increasingly being developed and used to address functional rehabilitation goals related to physical, cognitive, social, and psychological impairments. For example, a child with an acquired brain injury may participate in virtual rehabilitation to address impairments in balance, attention, turn taking, and engagement in therapy. The trend toward virtual rehabilitation first gained momentum with the adoption of commercial off-the-shelf active video gaming consoles (e.g., Nintendo Wii and XBox). Now, we are seeing the rapid emergence of customized rehabilitation-specific systems that integrate technological advances in virtual reality, visual effects, motion tracking, physiological monitoring, and robotics.
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]BACKGROUND This report presents the case of a 58-year-old man with right hemiplegia who improved his gait and lower limb motor function following virtual reality (VR)-based physical therapy. The use of augmented reality or VR-based technology is being increasingly used to support physical therapy in patients with motor deficits and to improve gait, and can be used in small hospitals and outpatient departments. CASE REPORT A 58-year-old man was diagnosed with left hemiplegia due to traumatic brain injury (TBI). He received 20 minutes of VR-based real-time feedback gait training and 30 minutes of general physical therapy, 5 times a week for 8 weeks. BioRescue was used for measurement of balance, GAITRite was used for measurement of gait, and Fugl-Meyer assessment was used for lower extremity motor function measurement. These were measured before the intervention and at 2, 4, 6, and 8 weeks after the intervention. After the intervention, center of pressure and limits of stability also increased. The affected step length, stride length, affected single support, and cadence were significantly increased after VR-based real-time feedback. Additionally, his lower extremity motor function score increased from 18 to 23 points. CONCLUSIONS This case report supports recent studies that have shown the value of VR-based methods as part of a physical therapy program in patients with problems with gait and motor function, including patients with stroke. VR-based real-time feedback showed favorable effects on rehabilitation following a TBI.
Robotic arm training in neurorehabilitation enhanced by augmented reality - a usability and feasibility study. [2023]Robotic therapy and serious gaming support motor learning in neurorehabilitation. Traditional monitor-based gaming outputs cannot adequately represent the third dimension, whereas virtual reality headsets lack the connection to the real world. The use of Augmented Reality (AR) techniques could potentially overcome these issues. The objective of this study was thus to evaluate the usability, feasibility and functionality of a novel arm rehabilitation device for neurorehabilitation (RobExReha system) based on a robotic arm (LBR iiwa, KUKA AG) and serious gaming using the AR headset HoloLens (Microsoft Inc.).
Safety and Potential Usability of Immersive Virtual Reality for Brain Rehabilitation: A Pilot Study. [2023]Objective: This study was conducted to demonstrate the safety and usability of an immersive virtual reality (VR) game as a rehabilitative training by assessing adverse events (AEs), adherence, and satisfaction in patients with brain injury who had free optional opportunities. Materials and Methods: The results were analyzed retrospectively. Seventy-eight patients with brain injury, undergoing rehabilitation treatment for motor impairment, were recruited. Among them, 51 were available for postintervention survey. The immersive type of VR training was programmed to facilitate use of the paralyzed upper extremity through a fishing simulation game. The Oculus Rift was used as head-mounted display device. Patients were observed for any AEs as defined in the Common Terminology Criteria for AEs during and after each VR training session. A postintervention telephone survey was done to investigate adherence-related factors and safety. Results: The results were analyzed after dividing the patients into nonadherence (patients participated <3 times) and high-adherence (≥3 times) groups. No serious AEs were reported during and after the VR training, and several patients reported other AEs, predominantly dizziness, with one case requiring cessation of VR training. Overall, the satisfaction rate was 54%. Compared with the nonadherence group, the high-adherence group expressed higher satisfaction with VR training, regarded it as effective for recovery from upper limb paralysis, accepted VR as comprehensible, and considered the level of difficulty to be appropriate (P < 0.05). Conclusion: Immersive VR training appeared to be safe for patients with brain injury.
Computerised mirror therapy with Augmented Reflection Technology for early stroke rehabilitation: clinical feasibility and integration as an adjunct therapy. [2022]New rehabilitation strategies for post-stroke upper limb rehabilitation employing visual stimulation show promising results, however, cost-efficient and clinically feasible ways to provide these interventions are still lacking. An integral step is to translate recent technological advances, such as in virtual and augmented reality, into therapeutic practice to improve outcomes for patients. This requires research on the adaptation of the technology for clinical use as well as on the appropriate guidelines and protocols for sustainable integration into therapeutic routines. Here, we present and evaluate a novel and affordable augmented reality system (Augmented Reflection Technology, ART) in combination with a validated mirror therapy protocol for upper limb rehabilitation after stroke.