Dual-task Augmented Reality Treatment for Parkinson's Disease

NCT ID: NCT04634331

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2022-08-08

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Traditional Multi-Modal Training

Intervention Type: BEHAVIORAL

Training administered via a 1:1 physical therapy session

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.

Group Type: EXPERIMENTAL

Augmented Reality Multi-Modal Training

Intervention Type: BEHAVIORAL

Training administered via an augmented reality headset.

Interventions

Augmented Reality Multi-Modal Training

Training administered via an augmented reality headset.

Intervention Type: BEHAVIORAL

Traditional Multi-Modal Training

Training administered via a 1:1 physical therapy session

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jay Alberts

Staff, Department of Biomedical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jay Alberts, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37465959 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-207

Identifier Type: -

Identifier Source: org_study_id