Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Parkinson Disease
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 50 individuals with Parkinson's disease will be randomized to either 1) traditional multi-modal training, or 2) augmented reality multi-modal training.Masking: Single (Investigator)Masking Description: The investigator performing the assessments will be blinded to group allocation.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Individuals with Parkinson's 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 part...

Individuals with Parkinson's 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 (2x/week for 8 weeks). The traditional multi-modal treatment will be administered 1:1 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.

Tracking Information

NCT #
NCT04634331
Collaborators
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Jay Alberts, PhD The Cleveland Clinic