Clinical trial NCT04634331: Dual-task Augmented Reality Treatment for Parkinson's Disease
Official title: Dual-task Augmented Reality Treatment for Parkinson's Disease (DART)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson disease
dual task
postural instability
gait dysfunction
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2020-11-18
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gait Velocity
timeFrame: From baseline assessment to the end of the 8-week training session
measure: MDS-UPDRS III Score
timeFrame: From baseline assessment to the end of the 8-week training session
measure: Fall Frequency
timeFrame: From baseline assessment to the end of the 8-week training session
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Jay Alberts, PhD
role: PRINCIPAL_INVESTIGATOR
References: