Dual-task Augmented Reality for PD DBS
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- Jay Alberts
- Study ID
- NCT06418152
- Status
- Completed
Conditions
- Deep Brain Stimulation
- Parkinson's Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Multi-modal treatment — BEHAVIORALMulti-modal treatment was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. MMT consists of simultaneously training a motor and cognitive task.
Study Details
The goal of this project is to evaluate the safety and preliminary 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 with a previously implanted deep brain stimulator (DBS).
Key Dates
- Start date
- May 21, 2024
- Status verified
- Sep 2025
- Primary completion
- Jan 30, 2025
- Completion
- Jan 30, 2025
Study Design
- Enrollment
- 7 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Interventional ArmFive to ten individuals with PD and DBS will receive the DART intervention. The 16 DART sessions will be delivered over an 8-week period (but not more than 10-weeks). Each DART session will consist of approximately 30-minutes of dual-task activity and will be scheduled over a 1 hour period. A physical therapist or physical therapist assistant will oversee each session. Exercises will be progressed based on results from the DART platform, feedback from the participant, and the clinical expertise of the physical therapist or physical therapist assistant
Primary Outcome Measure
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score [ Time Frame: Baseline and through study completion, average 8 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | - |
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