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

• ClinicalTrials.gov Identifier: NCT04634331
• Recruitment Status: Completed
• First Posted: November 18, 2020
• Last Update Posted: August 31, 2022
• Sponsor: The Cleveland Clinic
• Collaborator: Michael J. Fox Foundation for Parkinson's Research
• Information provided by (Responsible Party): Jay Alberts, The Cleveland Clinic

Tracking Information

• First Submitted Date: November 9, 2020
• First Posted Date: November 18, 2020
• Last Update Posted Date: August 31, 2022
• Actual Study Start Date: December 10, 2020
• Actual Primary Completion Date: August 8, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 12, 2020)

• Gait velocity [ Time Frame: From baseline assessment to the end of the 8-week training session ]
  Walking speed (m/s) on a self-paced treadmill during single and dual task conditions
• MDS-UPDRS III score [ Time Frame: From baseline assessment to the end of the 8-week training session ]
  Global score of motor function in Parkinson's disease; 18 items scored on a 0-4 scale; lower score indicates fewer PD motor symptoms
• Fall frequency [ Time Frame: From baseline assessment to the end of the 8-week training session ]
  number of falls in the previous 30 day period

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dual-task Augmented Reality Treatment for Parkinson's Disease
• Official Title: Dual-task Augmented Reality Treatment for Parkinson's Disease (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 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.
• Detailed 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 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.
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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

• Condition: Parkinson Disease

Intervention

• Behavioral: Augmented Reality Multi-Modal Training
  Training administered via an augmented reality headset.
• Behavioral: Traditional Multi-Modal Training
  Training administered via a 1:1 physical therapy session

Study Arms

• Active Comparator: Traditional Multi-Modal Training
  A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions)
  Intervention: Behavioral: Traditional Multi-Modal Training
• Experimental: Augmented Reality Multi-Modal Training
  Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist.
  Intervention: Behavioral: Augmented Reality Multi-Modal Training

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 30, 2022): 51
• Original Estimated Enrollment (submitted: November 12, 2020): 50
• Actual Study Completion Date: August 8, 2022
• Actual Primary Completion Date: August 8, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Adult with a diagnosis of idiopathic PD
2. Self-reported gait or balance deficits
3. Hoehn and Yahr stage I-III
4. Ability to ambulate >10 minutes continuously

Exclusion Criteria:

1. Diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent
2. >2 errors on the Short Portable Mental Status Questionnaire
3. Implanted deep brain stimulation electrodes
4. Musculoskeletal or cardiopulmonary issue that limits one's ability to engage in exercise
5. Neurological disease other than Parkinson's disease that impacts motor or cognitive function

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04634331
• Other Study ID Numbers: 20-207
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Jay Alberts, The Cleveland Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: The Cleveland Clinic
• Original Study Sponsor: Same as current
• Collaborators: Michael J. Fox Foundation for Parkinson's Research

Investigators

• Principal Investigator: Jay Alberts, PhD; The Cleveland Clinic

• PRS Account: The Cleveland Clinic
• Verification Date: August 2022