- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04634331
Dual-task Augmented Reality Treatment for Parkinson's Disease (DART)
August 30, 2022 updated by: Jay Alberts, The Cleveland Clinic
Dual-task Augmented Reality Treatment for Parkinson's Disease (DART)
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.
Study Overview
Status
Completed
Conditions
Intervention / 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
Enrollment (Actual)
51
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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)
|
Training administered via a 1:1 physical therapy session
|
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.
|
Training administered via an augmented reality headset.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From baseline assessment to the end of the 8-week training session
|
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
|
From baseline assessment to the end of the 8-week training session
|
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
|
From baseline assessment to the end of the 8-week training session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2020
Primary Completion (Actual)
August 8, 2022
Study Completion (Actual)
August 8, 2022
Study Registration Dates
First Submitted
November 9, 2020
First Submitted That Met QC Criteria
November 12, 2020
First Posted (Actual)
November 18, 2020
Study Record Updates
Last Update Posted (Actual)
August 31, 2022
Last Update Submitted That Met QC Criteria
August 30, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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