Dual-task Augmented Reality Treatment for Parkinson's Disease

Parkinson Disease Clinical Trial

— DART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04634331
• Other study ID #: 20-207
• Status: Completed
• Phase: Phase 2
• Start date: December 10, 2020
• Est. completion date: August 8, 2022

Study information

• Verified date: August 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

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