IVR ON UPPER-LIMB REHABILITATION IN STROKE PATIENTS: A CLINICAL TRIAL (REVICTUS)
Impact of Immersive Virtual Reality in the Rehabilitation in the Acute Phase of Stroke: a Clinical Study and Correlation With Blood Biomarkers and Polymorphisms Related to Neuroplasticity
연구 개요
상세 설명
The study will be conducted as a single-center, prospective, randomized, controlled, open-label clinical trial with blinded endpoint assessment. It aims to evaluate the benefits of neurorehabilitation combining conventional rehabilitation (CR) and immersive virtual reality (IVR) on patients' motor function and functional prognosis, as well as on the expression of blood biomarkers of neuroplasticity and the influence of specific genetic polymorphisms on rehabilitation response.
2. Study population
All patients meeting the following criteria will be included:
Inclusion criteria Diagnosis of ischemic stroke or intracerebral hemorrhage. Age > 18 years. < 7 days between stroke onset and inclusion in the study. Impairment of mobility in the right or left upper limb due to stroke. After hospital discharge, patients continue an intensive conventional rehabilitation (ICR) program at their referral rehabilitation center (MUTUAM).
Ability to understand and sign the study informed consent form (ICF) and the IDIBGI Biobank informed consent form.
Patients eligible for participation in the study will be those admitted to the Stroke Unit of Dr. Josep Trueta University Hospital (HUJT) with a diagnosis of ischemic stroke or intracerebral hemorrhage. Following clinical stabilization, and always within the first seven days after stroke onset, inclusion and exclusion criteria will be reviewed. Patients and their relatives will be informed about the study and will sign the informed consent forms (study and biobank). Patients will then be randomly assigned to one of the two study groups in a 1:1 ratio using a web-based platform and will be assigned an identification number for pseudonymization purposes.
The study groups will be:
Control group (CR): patients who will receive conventional rehabilitation (CR) in our hospital followed by an intensive conventional rehabilitation (ICR) program at the rehabilitation center.
Intervention group (CR+IVR): patients who will receive, in addition to CR, rehabilitation using the immersive virtual reality (IVR) system in our hospital, followed by the same ICR program as the control group together with IVR therapy at the rehabilitation center.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yolanda Silva, MD PhD
- 전화번호: 34972940262
- 이메일: ysilva.girona.ics@gencat.cat
연구 장소
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Girona, 스페인
- 모병
- Hospital Dr Josep Trueta
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연락하다:
- Yolanda Silva, MD PhD
- 전화번호: 34972940262
- 이메일: neurologia.girona.ics@gencat.cat
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부수사관:
- Mikel Terceño, MD PhD
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부수사관:
- Elisvan Rufino
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부수사관:
- Nuria Bas
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부수사관:
- Imma Boada
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부수사관:
- Elisabet Ortiz
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부수사관:
- Carme Gubern
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria: Diagnosis of ischemic stroke or intracerebral hemorrhage. Age > 18 years. < 7 days between stroke onset and inclusion in the study. Impairment of mobility in the right or left upper limb due to stroke. After hospital discharge, patients continue an intensive conventional rehabilitation (ICR) program at their referral rehabilitation center (MUTUAM).
Ability to understand and sign the study informed consent form (ICF) and the IDIBGI Biobank informed consent form.
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Exclusion Criteria:
Previous upper limb disability (neurological or non-neurological cause). Previous dementia or any disease with a life expectancy of less than 1 year. Language comprehension difficulties. Difficulty remembering exercise instructions. History of photosensitive epilepsy.
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Control Group
Control group (CR): patients who will receive conventional rehabilitation (CR) in our hospital followed by an intensive conventional rehabilitation (ICR) program at the rehabilitation center.
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활성 비교기: IVR group
Intervention group (CR+IVR): patients who will receive, in addition to CR, rehabilitation using the immersive virtual reality (IVR) system in our hospital, followed by the same ICR program as the control group together with IVR therapy at the rehabilitation center.
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patients who will receive, in addition to CR, rehabilitation using the immersive virtual reality (IVR) system in our hospital, followed by the same ICR program as the control group together with IVR therapy at the rehabilitation center.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Motor Function
기간: at 3 and 12 months
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NIHSS assessment of arm function
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at 3 and 12 months
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Quality of life of patients
기간: 3 and 12 months
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ECVI-38
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3 and 12 months
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Functional outcome
기간: 3 and 12 months
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modified Rankin scale
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3 and 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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FAC
기간: 3 and 12 months
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Assessment of FAC
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3 and 12 months
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Fugl-Meyer
기간: 3 and 12 months
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Fugl-Meyer Assessment
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3 and 12 months
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BBT
기간: 3 and 12 months
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Assessment of BBT (Box and Block Test)
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3 and 12 months
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9HPT
기간: 3 and 12 months
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Assessment of 9HPT (Nine-Hole Peg Test)
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3 and 12 months
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Safety measure
기간: 3 months
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Adverse events
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3 months
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .