NCT06409598Befejeződött
NOVEL Program for Stroke Telerehabilitation
Efficacy of NOn-immersive Virtual Reality Adapted Telerehabilitation Exercises for Upper Limb Function and Balance (NOVEL) Program in Stroke Patients: A Mixed Method Pilot Feasibility Study.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 8.
Rövid összefoglaló (regiszter, angolul)
Strokes are estimated to be the third most common cause of death in the world and the second most common cause of disability. Recently, the incidence of stroke has increased due to population aging. It is common for stroke survivors to experience a functional decline in their capacity to carry out daily activities as a consequence of their increasing dependence, which ultimately affects motivation levels, self-efficacy, and quality of life. Following a stroke, people often experience problems with upper limb function. Over half of people with upper limb impairments who have suffered a stroke continue to experience problems months or years afterward. A significant amount of rehabilitation is necessary to obtain meaningful recovery in the upper extremities and balance, but such interventions are difficult to access. As a cutting-edge method of neurorehabilitation, extended reality technology like virtual reality provides a more intensive simulation of functional activities than traditional physical therapy methods (aerobic, resistance, flexibility exercises, balance and coordination training, and functional exercises. The non-immersive type of VR can provide the patient with a safe experience so they can practice their exercises using gamification features integrated into the VR system, while remaining aware of their surroundings. According to the most recently published studies, there is promising evidence regarding the use of home-based exercises in stroke management especially after the Covid-19 pandemic. However, there is still a gap in identifying the evidence for using non-immersive home-based virtual reality exercises as telerehabilitation on the upper limb function and balance motor outcomes, adherence, and compliance with rehabilitation programs. In addition, no study have evaluated the validity and fidelity of the gamified features that can be added to the non-immersive VR exercises in terms of improving patient adherence and experience to their rehabilitation program. Moreover, the investigators still need rigorous qualitative studies to explore patient experiences after doing these exercises at home with remote monitoring from their rehabilitation team.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 27 (tényleges)
- Első benyújtás
- 2024. máj. 7.
- Kezdés
- 2024. júl. 31.
- Elsődleges befejezés
- 2026. ápr. 28.
- Fő szponzor
- University of Exeter
- Betegségek
- Stroke (szélütés)
- NCT-szám
- NCT06409598
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 27
- 2024. júl. 31. és az elsődleges befejezés (2026. ápr. 28.) 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
- To avoid potential confounding effects associated with other treatments, patients with any history of virtual reality upper-limb training or who received a botulinum toxin injection within 16 weeks before enrolment will be excluded.
- Concurrent enrolment in another investigational study.
Más betegség
- Having any medical contraindications (seizure disorders, symptomatic shoulder subluxation, artificial cardiac pacemaker device, persistent shoulder pain (\> 5 on VAS scale as an average).
Egyéb
- Having severe arm, leg, or spine contractures, or deformities (MAS 3 or 4).
- To ensure patients had sufficient cognitive abilities to participate in training and evaluation and to provide informed consent, the investigators will exclude patients diagnosed with - serious aphasia (cannot read the instructions) or cognitive dysfunction (inability to understand and follow two-stage instructions given by the investigators.
- Insufficient motor control to move the avatar on the screen.
- Pregnancy (self reported).
Kiket keres a vizsgálat
- Age \> 18 years old.
- Having stroke for more than 6 months (early or late chronic stage).
- Not participating in any other rehabilitation study.
- Able to read in English.
- Has good internet connection at home, or can the investigator give them a sim card.
- Score ≤2 on the Modified Ashworth Scale.
- Any degree of upper limb impairment due to stroke (Fugl-Meyer Assessment (FMA)-UE score \<57).
- Having sufficient space at home.
- The participant should have a laptop, computer at their home, if they don't have any of that, the investigator can loan them a laptop.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University Of Exeter Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Exeter | Egyesült Királyság | Ismeretlen állapot |
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