Status:
COMPLETED
Cueing-assisted Gamified Augmented-reality Gait-and-balance Rehabilitation at Home for People With Parkinson's Disease
Lead Sponsor:
VU University of Amsterdam
Conditions:
Parkinson Disease
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 exercis...
Detailed Description
Study design This study is a fully blinded two-armed pragmatic RCT, which will be executed in the Netherlands implemented at multiple physical or exercise therapy clinics. The study consists of three ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
April 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06590987
Start Date
April 18 2024
End Date
February 27 2025
Last Update
April 6 2025
Active Locations (1)
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1
Vrije Universiteit Amsterdam
Amsterdam, Netherlands