Dual-task Augmented Reality Treatment for Parkinson's Disease

NCT04634331 | Completed Phase 2 Results

• 1 other identifier: 20-207
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; dual task; postural instability; gait dysfunction

Outcome Measures

Primary Outcomes (3)

• 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

• MDS-UPDRS III Score

  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.

  From baseline assessment to the end of the 8-week training session

• Fall Frequency

  number of falls in the previous 30 day period

  From baseline assessment to the end of the 8-week training session

Study Arms (2)

Traditional Multi-Modal Training

ACTIVE COMPARATOR

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)

Behavioral: Traditional Multi-Modal Training

Augmented Reality Multi-Modal Training

EXPERIMENTAL

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.

Behavioral: Augmented Reality Multi-Modal Training

Interventions

Augmented Reality Multi-Modal Training BEHAVIORAL

Training administered via an augmented reality headset.

Augmented Reality Multi-Modal Training

Traditional Multi-Modal Training BEHAVIORAL

Training administered via a 1:1 physical therapy session

Traditional Multi-Modal Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Alberts JL, Kaya RD, Penko AL, Streicher M, Zimmerman EM, Davidson S, Walter BL, Rosenfeldt AB. A Randomized Clinical Trial to Evaluate a Digital Therapeutic to Enhance Gait Function in Individuals With Parkinson's Disease. Neurorehabil Neural Repair. 2023 Sep;37(9):603-616. doi: 10.1177/15459683231184190. Epub 2023 Jul 19.

  PMID: 37465959 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Jay Alberts
• Organization: Cleveland Clinic

albertj@ccf.org

216 445-3222

Study Officials

• Jay Alberts, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator performing the assessments will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff, Department of Biomedical Engineering

Model Details: 50 individuals with Parkinson's disease will be randomized to either 1) traditional multi-modal training, or 2) augmented reality multi-modal training.

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 18, 2020
• Study Start: December 10, 2020
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)