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NCT07032155Toborzás még nem indult

Virtual Reality in Occupational Therapy Upper Limb Stroke Rehabilitation

The Feasibility of Implementing Virtual Reality-based Upper Limb Rehabilitation for Stroke Patients and Occupational Therapists in an Acute Stroke Unit and Community Stroke Team, in Terms of Technology Acceptance, Safety and Usability

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jún. 22. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még

Rövid összefoglaló (regiszter, angolul)

The study aims to assess the feasibility of using Resynk, a virtual reality (VR) software platform for upper limb rehabilitation for stroke survivors, both in acute hospital settings and in the community (home, private nursing home, residential home). Resynk offers interactive, task-oriented training that enhances therapy intensity and patient motivation. Previous findings from a Quality Improvement project showed significant increases in treatment intensity and patient engagement with Resynk. This study will explore barriers to Resynk implementation and gather input from staff participants and stroke survivors to ensure successful integration and effectiveness. Resynk will be delivered alongside standard care, with no intention to delay or reduce existing rehabilitation services. The study involves two participant groups -adult stroke survivors and Occupational Therapists. These represent realistic and appropriate user groups for this stage of implementation research. A control group is not included, as the primary aim is not comparative effectiveness but to assess feasibility and user experience. This study will use a exploratory approach to using qualitative methods for gather insight into safety, acceptability and usability such as the System usability Scale, EQ-5D-5L and custom design Questionnaire. Quantitative methods will be used for evaluating rehabilitating and function outcomes this includes data collected by the Resynk application and the standardised Fugl Meyers assessment. The study will involve pre, post and follow up data collection for both participant groups.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
30 (tervezett)
Első benyújtás
2025. jún. 5.
Kezdés
2025. júl. 1.
Elsődleges befejezés
2025. dec. 31.
Fő szponzor
eXRt Intelligent Healthcare
NCT-szám
NCT07032155

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 30
  • 2025. júl. 1. és az elsődleges befejezés (2025. dec. 31.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Stroke onset more than 3 months prior to study entry.
  • Current participation in another clinical trial involving rehabilitation (e.g., recreational therapy, occupational therapy, physiotherapy) or an investigational drug that might interfere with study results.
  • Patients with implanted devices such as pacemakers, defibrillators, and cochlear implants.
  • Current participation in another clinical trial involving rehabilitation (e.g., recreational therapy, occupational therapy, physiotherapy) or an investigational drug that might interfere with study results.
  • Staff members with implanted devices such as pacemakers, defibrillators, and cochlear implants.

Más betegség

  • Stroke Participants:
  • Patient is unable to follow verbal commands or has global aphasia. Interpreters may be used to accommodate stroke survivors' communication needs.
  • Severe illness with a life expectancy of less than 3 months (e.g., cancer, endocarditis, metastasis with an occult primary malignancy).
  • Uncontrolled hypertension as assessed by the treating physician.
  • Unstable angina or recent myocardial infarction.
  • Any history of epilepsy or seizures, except for febrile seizures of childhood.
  • Any physical health condition, mental health condition, or other medical condition or diagnosis that might confound the interpretation of results or put the patient at risk (e.g., amputation of one extremity).
  • History of vertigo.
  • Uncontrolled hypertension as assessed by the treating physician.
  • Unstable angina or recent myocardial infarction
  • Any history of epilepsy, seizures, except for febrile seizures of childhood.
  • Any physical health condition, mental health condition, or other medical condition or diagnosis that might confound the interpretation of results or put the patient at risk (e.g., amputation of one extremity).
  • History of vertigo.

Egyéb

  • Acutely medically unwell as per medical team
  • Patient is unwilling or unable to comply with the protocol or cannot/will not cooperate fully with the investigator or study personnel.
  • Active delirium/significant levels of confusion
  • Cervical artery dissection.
  • Individual currently being managed under the Mental Capacity Act
  • Staff participants:
  • Cervical artery dissection.

Kiket keres a vizsgálat

  • Stroke Participants
  • Able to provide informed consent
  • Aged over 18 years.
  • Evidence of stroke confirmed by medical team
  • Newly diagnosed patients who are admitted to the acute stroke unit with a confirmed diagnosis of stroke.
  • More than 48 hours since stroke event
  • Patient is appropriate to participate in rehabilitation according to the treating physician or medical consultant, and able to follow simple verbal commands.
  • Presence of an upper limb deficit identified in the NIHSS (National Institutes of Health Stroke Scale) or by a member of the medical or multidisciplinary team
  • Residents within the Belfast health and social care trust catchment area/postcode
  • Staff participants:
  • Qualified Registered Occupational Therapy Staff who work in the Stroke Unit in the Royal Victoria Hospital Belfast or in the Community Stroke Team in the Belfast Health and Social Care Trust.
  • Able to provide informed consent
  • Aged 18 or over

Életkor a regiszterben: 18 év – 99 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Royal Victoria Hospital
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BelfastEgyesült KirályságIsmeretlen állapot

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