NCT06590987Befejeződött
Cueing-assisted Gamified Augmented-reality Gait-and-balance Rehabilitation at Home for People With Parkinson's Disease
Cueing-assisted Gamified Augmented-reality Gait-and-balance Rehabilitation at Home for People With Parkinson's Disease: Protocol of a Pragmatic Randomized Controlled Trial Implemented in the Clinical Pathway
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. ápr. 6.
Rövid összefoglaló (regiszter, angolul)
Background: Physiotherapy in the clinic is highly recommended for improving gait, balance and falls risk in people with Parkinson's disease. In addition, technology may help boost unsupervised exercise hours at home. Strolll is an augmented-reality (AR) neurorehabilitation platform for delivering gait-and-balance exercises onto AR glasses that can be performed under direct supervision of the therapist in the clinic, but also independently at home. Strolll AR also has the option to integrate AR cueing in gait-and-balance exercises to assist people with more severe mobility impairments in performing the exercises. The objective of this pragmatic randomized controlled trial (RCT) on Strolll AR is to examine its clinical feasibility and effectiveness for improving indicators of gait, balance and falls risk. A secondary objective is to evaluate procedures for tailoring assistive AR cues. Methods: 80-100 people with Parkinson's disease (Hoehn and Yahr stages 1-3) with gait and/or balance impairments will participate in this study. This study is a pragmatic RCT in which all participants follow the same procedure. After a baseline assessment (T0), participants will start with a 6-week usual care control period, followed by a midterm assessment (T1). Subsequently, participants will undergo two weeks of in-clinic familiarization with Strolll AR. Then, participants will start with the 6-week Strolll AR intervention at home, followed by a final in-clinic assessment (T2). The primary study parameters are feasibility (i.e., safety, adherence, performance and user experience) and effectiveness for improving indicators of gait, balance and falls risk. For the statistical analyses on effectiveness, participants will be allocated to control (using T0-T1 change data) or intervention (using T1-T2 change data) groups using multiple (n=20) randomizations. Recruitment started in May 2024 and the last T2 assessment is expected in January 2025. Discussion: The design of this particular pragmatic RCT will demonstrate feasibility and effectiveness in a real-world setting and in a representative population. Strolll AR may facilitate the transition from supervised care in the clinic to independent care at home, providing a platform for delivering individualized treatment, assisted with AR cues when deemed beneficial, for improving gait, balance and falls risk in people with Parkinson's disease.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 100 (tényleges)
- Első benyújtás
- 2024. febr. 5.
- Kezdés
- 2024. ápr. 18.
- Elsődleges befejezés
- 2025. febr. 21.
- Fő szponzor
- VU University of Amsterdam
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT06590987
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 100
- 2024. ápr. 18. és az elsődleges befejezés (2025. febr. 21.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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- To be eligible to participate, a person must meet the following criteria:
- 21 years or older
- have command of the Dutch language
- diagnosed with Parkinson's disease according to the UK Parkinson's Disease Brain Bank criteria (stages 1-3 on the Hoehn and Yahr scale)
- bothersome gait or balance impairments (i.e., negatively affecting their ability to perform their usual daily activities as indicated by the person with Parkinson's disease and/or their therapist).
- A potential participant who meets any of the following criteria will be excluded from participation:
- inability to comply with the protocol, i.e. additional neurological diseases and/or orthopedic problems seriously interfering with gait function
- insufficient physical capacity to safely perform the intervention (e.g., frequent faller) or severe cognitive impairments (as observed by the therapist)
- visual or hearing impairments (after corrective aids)
- inability to walk independently for 30 minutes (in bouts of 5-10 minutes)
- severe visual hallucinations or illusions
- no stable dosage of medication.
- Finally, in case potential participants are susceptible to hallucinations, have a history of seizures, have deep brain stimulation, or a pacemaker, it should be discussed with their therapist if they can participate, as per Strolll's Instructions For Use (DOC-IFU-00021 (NL), Revision 01, Date of Issue 06 2024).
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Helyszínek (1)
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| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Vrije Universiteit Amsterdam | Amsterdam | Hollandia | Ismeretlen állapot |
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