Virtual Reality Based Interventions After Brain Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorDanderyd Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with acquired brain injury in need of multiprofessional rehabilitation admitted to the clinic are eligible if they
are between 18 and 65 years;
present with attention deficits and
are deemed suitable for direct attention training by the rehabilitation team.
Disqualifiers
Epilepsy or suspected epilepsy;
non-fluent in Swedish
severe fatigue or/and cognitive dysfunction that makes participation difficult.
Trial design
Design model
Parallel
Treatments tested in this trial
VR/AR intervention
BehavioralParticipants 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.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: VR/AR interventionActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 intervention2
WAIS-IV Coding
measures processing speed.
Time frame
before the intervention and within 3 weeks after the intervention3
Color-Word Interference Test
measures cognitive flexibility and selective attention.
Time frame
before the intervention and within 3 weeks after the intervention4
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 interventionSecondary outcomes
1
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 intervention2
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 intervention3
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 intervention4
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Danderyd Hospital
Lead sponsor
Stiftelsen Promobila
Collaborator
Source ClinicalTrials.gov
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