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Completed

NCT Number: NCT04634331

Dual-task Augmented Reality Treatment for Parkinson's Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Augmented Reality Multi-Modal Training

Behavioral

Training administered via an augmented reality headset.

Traditional Multi-Modal Training

Behavioral

Training administered via a 1:1 physical therapy session

Primary outcomes

  1. 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

  2. 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 using the Movement Disorders Society-Unified Parkinson's Disease Rating Scale subscale III (MDS-UPDRS III). Eighteen items scored on a 0-4 scale resulting in a score ranging from 0-72. A higher score (larger number) indicates more motor symptoms.

  3. 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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

Registry information

Official study title

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

Acronym: DART

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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