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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Augmented Reality Multi-Modal Training
Traditional Multi-Modal Training
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, dual task, postural instability, gait dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Multi-Modal Training

Augmented Reality Multi-Modal Training

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Gait velocity
Walking speed (m/s) on a self-paced treadmill during single and dual task conditions
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
Fall frequency
number of falls in the previous 30 day period

Secondary Outcome Measures

Full Information

First Posted
November 9, 2020
Last Updated
August 30, 2022
Sponsor
The Cleveland Clinic
Collaborators
Michael J. Fox Foundation for Parkinson's Research
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1. Study Identification

Unique Protocol Identification Number
NCT04634331
Brief Title
Dual-task Augmented Reality Treatment for Parkinson's Disease
Acronym
DART
Official Title
Dual-task Augmented Reality Treatment for Parkinson's Disease (DART)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
August 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Michael J. Fox Foundation for Parkinson's Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson disease, dual task, postural instability, gait dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
The investigator performing the assessments will be blinded to group allocation.
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Multi-Modal Training
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Augmented Reality Multi-Modal Training
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Augmented Reality Multi-Modal Training
Intervention Description
Training administered via an augmented reality headset.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Multi-Modal Training
Intervention Description
Training administered via a 1:1 physical therapy session
Primary Outcome Measure Information:
Title
Gait velocity
Description
Walking speed (m/s) on a self-paced treadmill during single and dual task conditions
Time Frame
From baseline assessment to the end of the 8-week training session
Title
MDS-UPDRS III score
Description
Global score of motor function in Parkinson's disease; 18 items scored on a 0-4 scale; lower score indicates fewer PD motor symptoms
Time Frame
From baseline assessment to the end of the 8-week training session
Title
Fall frequency
Description
number of falls in the previous 30 day period
Time Frame
From baseline assessment to the end of the 8-week training session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Alberts, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dual-task Augmented Reality Treatment for Parkinson's Disease

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