이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Virtual Reality Based Interventions After Brain Injury

2026년 5월 8일 업데이트: Jonas Stenberg, Danderyd Hospital

The Effectiveness of Virtual Reality Based Interventions on Cognitive Function After Brain Injury

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.

연구 개요

상태

아직 모집하지 않음

상세 설명

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.

연구 유형

중재적

등록 (추정된)

15

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

Participants will be recruited from both the inpatient and outpatient units at the Department of Rehabilitation Medicine, Danderyd Hospital.

Inclusion criteria:

  1. Patients with acquired brain injury in need of multiprofessional rehabilitation admitted to the clinic are eligible if they
  2. are between 18 and 65 years;
  3. present with attention deficits and
  4. are deemed suitable for direct attention training by the rehabilitation team.

Exclusion Criteria:

  1. Epilepsy or suspected epilepsy;
  2. non-fluent in Swedish
  3. severe fatigue or/and cognitive dysfunction that makes participation difficult.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: VR/AR intervention
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.
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.
간섭 없음: Control
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
WAIS-IV digit span
기간: before the intervention and within 3 weeks after the intervention
Digit span forwards measures short-term memory, attention and auditory processing ability. Digit span backwards measures working memory and mental processing ability
before the intervention and within 3 weeks after the intervention
WAIS-IV Coding
기간: before the intervention and within 3 weeks after the intervention
measures processing speed.
before the intervention and within 3 weeks after the intervention
Color-Word Interference Test
기간: before the intervention and within 3 weeks after the intervention
measures cognitive flexibility and selective attention.
before the intervention and within 3 weeks after the intervention
The Conners Continuous Performance Test (CPT)-III
기간: before the intervention and within 3 weeks after the intervention
measures sustained attention, reaction time, and impulsivity.
before the intervention and within 3 weeks after the intervention
d2 Test of Attention
기간: before the intervention and within 3 weeks after the intervention
measures selective and sustained attention, concentration, and processing speed
before the intervention and within 3 weeks after the intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Hospital Anxiety and Depression Scale (HADS)
기간: before the intervention and within 3 weeks after the intervention
a 14-item questionnaire used to screen for symptoms of anxiety and depression, particularly in medical settings.
before the intervention and within 3 weeks after the intervention
Mental Fatigue Scale (MFS)
기간: before the intervention and within 3 weeks after the intervention
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
before the intervention and within 3 weeks after the intervention
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
기간: before the intervention and within 3 weeks after the intervention
a 16-item self-report tool used to measure the severity of post-concussion symptoms after a traumatic brain injury.
before the intervention and within 3 weeks after the intervention
Canadian Occupational Performance Measurement (COPM)
기간: before the intervention and within 3 weeks after the intervention
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.
before the intervention and within 3 weeks after the intervention
Patient Competency Rating Scale (PCRS)
기간: before the intervention and within 3 weeks after the intervention
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.
before the intervention and within 3 weeks after the intervention
Situational Motivation Scale (SIMS)
기간: before the intervention and within 3 weeks after the intervention
consist of 16 items and measures intrinsic and extrinsic motivation in different situations and activities.
before the intervention and within 3 weeks after the intervention
Satisfaction questionnaire
기간: within 3 weeks after the intervention
A satisfaction questionnaire developed in-house
within 3 weeks after the intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Jonas Stenberg, PhD, Danderyd Hospital / Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2028년 7월 31일

연구 등록 날짜

최초 제출

2026년 5월 4일

QC 기준을 충족하는 최초 제출

2026년 5월 8일

처음 게시됨 (실제)

2026년 5월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 8일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Due to swedish legislation

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다