Phase 2
Completed N=51
Dual-task Augmented Reality Treatment for Parkinson's Disease
Source: ClinicalTrials.gov NCT04634331 ↗Enrolled (actual)
51
Serious AEs
2.0%
Results posted
Sep 2024
Primary outcomePrimary: Gait Velocity — 1.20; 1.22; 1.03; 1.07 meters/second
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 Parkinson's 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 Parkinson's 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 (i.e. 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 2x/week for a total of 8 weeks. Assessments involving walking, balancing, and turning will be completed to assess the efficacy of the treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gait Velocity |
1.20; 1.22; 1.03; 1.07; 1.05; 1.09 | — |
| PRIMARY MDS-UPDRS III Score |
34.1; 37.6; 34.9; 36.6 | — |
| PRIMARY Fall Frequency |
0.5; 0.68; 0.64; 0.52 | — |
Eligibility Criteria
Inclusion Criteria
- Adult with a diagnosis of idiopathic PD
- Self-reported gait or balance deficits
- Hoehn and Yahr stage I-III
- Ability to ambulate >10 minutes continuously
Exclusion Criteria
- Diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent
- >2 errors on the Short Portable Mental Status Questionnaire
- Implanted deep brain stimulation electrodes
- Musculoskeletal or cardiopulmonary issue that limits one's ability to engage in exercise
- Neurological disease other than Parkinson's disease that impacts motor or cognitive function
Data sourced from ClinicalTrials.gov (NCT04634331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.