Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634331
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2020-11-09
Brief Title:
Dual-task Augmented Reality Treatment for Parkinsons Disease
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Dual-task Augmented Reality Treatment for Parkinsons Disease DART
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DART
Brief Summary:
Activities of daily living ADL frequently involve the simultaneous performance of two or more tasks such as crossing the street while holding a conversation commonly referred to as dual tasking The simultaneous performance of a motor and a cognitive task increases postural instability gait dysfunction and may increase fall rates in Parkinsons disease PD The goal of this project is to evaluate the effectiveness of utilizing a digital therapeutic Dual-task Augmented Reality Treatment DART protocol for the treatment of postural instability and gait dysfunction PIGD in individuals with PD A randomized controlled trial will be conducted at the Main Campus of the Cleveland Clinic Cleveland OH A total of 50 individuals with Parkinsons disease will be randomized into 1 a traditional multi-modal training group or 2 multi-modal training administered via an augmented reality headset Multi-modal therapy is where the participant practices performing two things at once ie marching while answering math questions Augmented reality is a type of head-worn technology that allows the individual to see the real world and places holograms in the space Both groups will exercise 2xweek for a total of 8 weeks Assessments involving walking balancing and turning will be completed to assess the efficacy of the treatment
Detailed Description:
Individuals with Parkinsons disease who qualify for the study will come to the Cleveland Clinic for an informed consent visit At the informed consent visit the participant will receive an activity monitor and a fall diary Following a 4-week period where activity and falls are monitored the participant will come to the Cleveland Clinic for a comprehensive physical and cognitive assessment primarily using a virtual reality treadmill system During that baseline assessment the individual will be randomized to either 1 traditional multi-modal training or 2 augmented reality multi-modal training Regardless of group allocation the participant will complete a total of 16 treatment sessions 2xweek for 8 weeks The traditional multi-modal treatment will be administered 11 by a physical therapist The augmented reality multi-modal training will be overseen by a physical therapist and administered via the Microsoft HoloLens 2 augmented reality device Follow-up assessments will be conducted at the end of the 16 treatment sessions and 8 weeks after the treatment sessions have ceased Falls and activity data will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None