CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Augmented Reality Multi-Modal Training +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04634331
NCT04634331Phase 2Completed

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

The Cleveland Clinic·interventional·Posted Nov 18, 2020·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Augmented Reality Multi-Modal Training and Traditional Multi-Modal Training for Parkinson Disease. Completed, enrolled 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 18, 2020
Enrollment StartDec 10, 2020
Primary CompletionAug 8, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.6 years ago

Interventions

Augmented Reality Multi-Modal Trainingbehavioral

Training administered via an augmented reality headset.

Traditional Multi-Modal Trainingbehavioral

Training administered via a 1:1 physical therapy session