An interventional study of VR/AR intervention in Acquired Brain Injury (Including Stroke), sponsored by Danderyd Hospital. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Danderyd Hospital · Not applicable, Interventional, and Treatment
After a brain injury, cognitive impairments are common, affecting an individual's independence and quality of life. Although various training programs are used in rehabilitation, it remains unclear how effective they are in real-life settings. The project now being planned at CogTech, a technology-driven rehabilitation unit at Danderyd Hospital, aims to evaluate new methods that can enhance both training effectiveness and motivation.
In the project, the effect of game-based training in virtual reality (VR) on cognition will be evaluated. VR offers a more realistic and engaging environment, which may improve the transfer of training outcomes to everyday situations. In this feasibility study, ten patients at the clinic will receive VR-training at 15 occasions in addition to rehabilitation as usual.
The results may contribute to the development of more individualized rehabilitation, reduced treatment times, and improved quality of life for people with brain injury.
The overarching aim of this project is to evaluate the effectiveness of CogTech's technology-assisted interventions on cognitive and visual functioning in patients undergoing rehabilitation following acquired brain injury. Within the scope of this umbrella project, the initial intervention to be evaluated is VR gaming. The first aim is to investigate the feasibility of a VR-game clinical trial. The feasibility study will be conducted with approximately ten patients. The primary aim of this phase is to inform key design decisions for a subsequent RCT (including 90 patients). Specifically, the feasibility study will evaluate: the suitability of different VR games and headsets, the optimal intensity and duration of the VR-based training sessions, and the appropriate level and format of therapist involvement during the intervention.
Participants will be recruited from both the inpatient and outpatient units at the Department of Rehabilitation Medicine, Danderyd Hospital. Before enrollment in a rehabilitation program, all patients are comprehensively assessed by the rehabilitation team ("the assessment phase", with a typical duration of two to three weeks). During this phase, a neuropsychological assessment is performed by a neuropsychologist and an activity-based assessment is performed by an occupational therapist. Based on these assessments, the rehabilitation team concludes whether attention deficits are present and direct attention training is indicated (Attention Process Training11 is the standard at the clinic). Participants will be recruited among these patients. The VR intervention will be offered as an add-on to the other interventions in the rehabilitation program. The content of the rehabilitation program varies between patients, but typically includes attention process training for attention deficits, strategy training for executive deficits and physiotherapy for physical and motor deficits. The length of the rehabilitation program is typically 12 to 16 weeks.
In the feasibility study, eligible patients will consequently be informed about the study after the clinical assessment phase and will be asked for informed consent (n=10). Following the recruitment to the VR-intervention, five patients will be asked to serve as control participants. They will undergo the baseline assessment and the post-intervention assessment, but will not do the VR-based training.
Following informed consent, baseline assessments will be conducted and demographic and injury-related data will be collected. Some of the tests that will be used in the study will already have been administered as part of the clinical routine. These tests will not be re-administered in the pre-assessment. Following informed consent, the clinical psychologist who has assessed the patient will hand over the test results along with demographic and injury-related data to the responsible researcher.
Post-intervention assessments will be conducted after the 5-week training period and before the patient is discharged. All measures from the pre-assessment will be readministered, except WAIS (Wechsler Adult Intelligence Scale)-IV Matrix Reasoning, Rey Auditory Verbal Learning Task, Rey Complex Figure Task. We do not expect an intervention effect on these measures but they are potentially modifiers of treatment effect. A satisfaction questionnaire developed in house will be used and will only be administered post-intervention.
In the feasibility study, the focus will be to evaluate different VR games and headsets, the optimal intensity and duration of the VR-based training sessions, and the appropriate level and format of therapist involvement during the intervention. Results on the SIMS and the satisfaction questionnaire will be emphasized, but pre- to post changes on all measures will be calculated.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 15 is below the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Danderyd Hospital is the lead sponsor of 60 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Participants will be recruited from both the inpatient and outpatient units at the Department of Rehabilitation Medicine, Danderyd Hospital.
Inclusion criteria:
Exclusion Criteria:
Participants will engage in cognitively demanding games such as Beat Saber, Zooma, or XR Brain Stimulation for 30-60 minutes, 3 days a week for 5 weeks using an augmented reality (AR) (RehAtt® XR) or VR headset (i.e., Meta Quest 3 or Oculus Rift S). Beat Saber and Zooma are both commercially available games. In Beat Saber players use two colored sabers to slice incoming music-synchronized blocks in the directions indicated, while also dodging obstacles like walls and bombs. Zooma involves shooting rolling colored balls to create matches before they reach the endpoint ("snapdragon"), using both hands for faster color-matching. XR Brain Stimulation is developed to be used in brain injury rehabilitation and involves 3D games in the form of holograms integrated in the real surroundings.
Behavioral: VR/AR intervention
Five patients will be asked to serve as control participants. They will undergo the baseline assessment and the post-intervention assessment, but will not do the VR-based training.
Participants will engage in cognitively demanding games such as Beat Saber, Zooma, or XR Brain Stimulation for 30-60 minutes, 3 days a week for 5 weeks using an augmented reality (AR) (RehAtt® XR) or VR headset (i.e., Meta Quest 3 or Oculus Rift S). Beat Saber and Zooma are both commercially available games. In Beat Saber players use two colored sabers to slice incoming music-synchronized blocks in the directions indicated, while also dodging obstacles like walls and bombs. Zooma involves shooting rolling colored balls to create matches before they reach the endpoint ("snapdragon"), using both hands for faster color-matching. XR Brain Stimulation is developed to be used in brain injury rehabilitation and involves 3D games in the form of holograms integrated in the real surroundings.
WAIS-IV digit span
Digit span forwards measures short-term memory, attention and auditory processing ability. Digit span backwards measures working memory and mental processing ability
Time frame: before the intervention and within 3 weeks after the intervention
WAIS-IV Coding
measures processing speed.
Time frame: before the intervention and within 3 weeks after the intervention
Color-Word Interference Test
measures cognitive flexibility and selective attention.
Time frame: before the intervention and within 3 weeks after the intervention
The Conners Continuous Performance Test (CPT)-III
measures sustained attention, reaction time, and impulsivity.
Time frame: before the intervention and within 3 weeks after the intervention
d2 Test of Attention
measures selective and sustained attention, concentration, and processing speed
Time frame: before the intervention and within 3 weeks after the intervention
Hospital Anxiety and Depression Scale (HADS)
a 14-item questionnaire used to screen for symptoms of anxiety and depression, particularly in medical settings.
Time frame: before the intervention and within 3 weeks after the intervention
Mental Fatigue Scale (MFS)
a 15-item self-report questionnaire used to assess mental fatigue, often after brain injury, neurological illness, or concussion. It measures difficulties such as fatigue, lack of initiative, mental
Time frame: before the intervention and within 3 weeks after the intervention
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
a 16-item self-report tool used to measure the severity of post-concussion symptoms after a traumatic brain injury.
Time frame: before the intervention and within 3 weeks after the intervention
Canadian Occupational Performance Measurement (COPM)
is a is a client-centered assessment that identifies daily activities a person wants, needs, or is expected to do but has difficulty performing. It uses a structured interview to help the client rate the importance, performance, and satisfaction of chosen activities. The scores are then used to guide treatment and measure change over time.
Time frame: before the intervention and within 3 weeks after the intervention
Patient Competency Rating Scale (PCRS)
is a 30-item questionnaire in which the respondent on a 5-point Likert scale rate his or her degree of difficulty in a variety of everyday tasks.
Time frame: before the intervention and within 3 weeks after the intervention
Situational Motivation Scale (SIMS)
consist of 16 items and measures intrinsic and extrinsic motivation in different situations and activities.
Time frame: before the intervention and within 3 weeks after the intervention
Satisfaction questionnaire
A satisfaction questionnaire developed in-house
Time frame: within 3 weeks after the intervention
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Due to swedish legislation
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Danderyd Hospital