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Virtual Reality Based Interventions After Brain Injury

2026年5月8日 更新者: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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

介入

入学 (推定)

15

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.
介入なし: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
WAIS-IV digit span
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Hospital Anxiety and Depression Scale (HADS)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠:within 3 weeks after the intervention
A satisfaction questionnaire developed in-house
within 3 weeks after the intervention

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Jonas Stenberg, PhD、Danderyd Hospital / Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2027年12月31日

研究の完了 (推定)

2028年7月31日

試験登録日

最初に提出

2026年5月4日

QC基準を満たした最初の提出物

2026年5月8日

最初の投稿 (実際)

2026年5月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月14日

QC基準を満たした最後の更新が送信されました

2026年5月8日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

Due to swedish legislation

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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