Dual-task Augmented Reality Treatment (DART) Protocol for Parkinson’s Disease

Study Rationale:
Approximately 80 percent of people with Parkinson’s disease fall due to problems with posture, walking and balance, known as postural and gait dysfunction (PIGD) one or more times a year. This reduces  quality of life and independence.  Our successful randomized clinical trial demonstrated that a therapeutic approach that combines cognitive and motor training (multi-modal training (MMT) effectively treats PIGD and decreases falls in people with Parkinson’s.  Although effective, MMT is directed by a physical therapist and places significant time demands on patients and therapists that does not make it practical to implement. To solve this problem, we are using augmented reality technology, which superimposes a computer-generated image on a user's view of the real world. The type of augmented reality we are using is a digital tool called Dual-task Augmented Reality Treatment (DART). It will be self-administered by patients, reducing time requirements for therapist and providing flexibility of use for the patient. The aim of this project is to conduct a ground-breaking study of PIGD in Parkinson’s.

Hypothesis:
People training with DART will exhibit a similar outcome to people training with a therapist-led MMT group: at least 90 percent of the treatment effect of the therapist-led MMT group on the primary outcomes characterizing PIGD (such as walking speed and stride length) and reducing 30-day fall rates.

Study Design:
People with Parkinson’s will be randomly assigned to DART (25) or therapist-led (25) groups. Patients randomized to the DART group will be asked to complete 16 sessions (2x per week for 8 weeks). They will use DART technology to  simultaneously complete functional and cognitive-based tasks that become progressively more difficult. A physical therapist will deliver the MMT intervention to patients in the therapist-led group over 8 weeks (twice per week) using the model that was successful in our recent study. The primary outcomes for both groups will be number of falls in 30 days and objective biomechanical measures (posture difficulties, walking speed, stride length and the number of steps per minute) characterizing PIGD from the start of the study to post-treatment and four weeks following each treatment.

Impact on Diagnosis/Treatment of Parkinson’s disease:
The impact of this proposal is in its potential to create a digital therapeutic that will (1) provide trusted and validated measures of lower extremity function under “real-world” conditions, (2) be an effective method for treating the persistent effects of PIGD, and (3) be easily reproduced and thus equalize the inequity of current Parkinson’s care in rural and underserved populations. Results from this project will inform the pivotal FDA trial for the development of a digital treatment.

Next Steps for Development:
Outcome data from DART will be automatically integrated into the electronic health record of patients. Integration of technology into the clinical workflow and the integration of information into the health record will facilitate widespread clinical use of DART to advance Parkinson’s care.