NCT04634331: DART

Dual-task Augmented Reality Treatment for Parkinson's Disease

Completed Phase 2 Results posted Last updated 19 September 2024

What this trial tests

Phase 2 trial testing Augmented Reality Multi-Modal Training in Parkinson Disease in 51 participants. Completed in 8 August 2022.

Timeline

10 December 2020

Primary endpoint
8 August 2022

8 August 2022

Quick facts

Lead sponsor	The Cleveland Clinic
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	51
Start date	10 December 2020
Primary completion	8 August 2022
Estimated completion	8 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Augmented Reality Multi-Modal Training
• Traditional Multi-Modal Training

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

The Cleveland Clinic

Who can join

18 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Gait Velocity Primary · 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

Baseline Single-task Walk Speed

Group	Value	95% CI
Traditional Multi-Modal Training	1.20	± 0.19
Augmented Reality Multi-Modal Training	1.22	± 0.20

Baseline Serial 7 Dual-Task Walk Speed

Group	Value	95% CI
Traditional Multi-Modal Training	1.03	± 0.24
Augmented Reality Multi-Modal Training	1.07	± 0.29

Baseline Digit Recall Dual-Task Walk Speed

Group	Value	95% CI
Traditional Multi-Modal Training	1.05	± 0.18
Augmented Reality Multi-Modal Training	1.09	± 0.23

Baseline Controlled Oral Word Association Dual-Task Walk Speed

Group	Value	95% CI
Traditional Multi-Modal Training	1.09	± 0.19
Augmented Reality Multi-Modal Training	1.11	± 0.24

Baseline Stroop Dual-Task Walk Speed

Group	Value	95% CI
Traditional Multi-Modal Training	1.11	± 0.23
Augmented Reality Multi-Modal Training	1.19	± 0.25

Baseline 1-Back Dual-Task Walk Speed

Group	Value	95% CI
Traditional Multi-Modal Training	1.07	± 0.27
Augmented Reality Multi-Modal Training	1.11	± 0.27

Baseline 2-Back Dual-Task Walk Speed

Group	Value	95% CI
Traditional Multi-Modal Training	1.08	± 0.27
Augmented Reality Multi-Modal Training	1.09	± 0.29

End of Treatment Single-task Walk

Group	Value	95% CI
Traditional Multi-Modal Training	1.27	± 0.19
Augmented Reality Multi-Modal Training	1.33	± 0.25

MDS-UPDRS III Score Primary · 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.

Baseline MDS-UPDRS III Score

Group	Value	95% CI
Traditional Multi-Modal Training	34.1	± 13.1
Augmented Reality Multi-Modal Training	37.6	± 12.3

End of Treatment MDS-UPDRS III Score

Group	Value	95% CI
Traditional Multi-Modal Training	34.9	± 11.4
Augmented Reality Multi-Modal Training	36.6	± 12.8

Fall Frequency Primary · From baseline assessment to the end of the 8-week training session

number of falls in the previous 30 day period

Baseline Number of falls

Group	Value	95% CI
Traditional Multi-Modal Training	0.5	± 1.22
Augmented Reality Multi-Modal Training	0.68	± 1.14

End of Treatment Number of Falls

Group	Value	95% CI
Traditional Multi-Modal Training	0.64	± 1.59
Augmented Reality Multi-Modal Training	0.52	± 0.71

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected over the 5 month study enrollment for each participant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Traditional Multi-Modal Training

Serious: 0/24 (0%)

Deaths: 0/24

Augmented Reality Multi-Modal Training

Serious: 1/27 (4%)

Deaths: 0/27

Serious adverse events (1 terms)

Reaction	System	Traditional Multi-Modal Tr…	Augmented Reality Multi-Mo…
Fall	Injury, poisoning and procedural complications	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Traditional Multi-Modal Tr…	Augmented Reality Multi-Mo…
Fall	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Fall.

Data from ClinicalTrials.gov NCT04634331 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions for preventing falls in Parkinson's disease.
   Allen NE, Canning CG, Almeida LRS, Bloem BR, et al · · 2022 · cited 50× · PMID 35665915 · DOI 10.1002/14651858.cd011574.pub2
2. A Randomized Clinical Trial to Evaluate a Digital Therapeutic to Enhance Gait Function in Individuals With Parkinson's Disease.
   Alberts JL, Kaya RD, Penko AL, Streicher M, et al · · 2023 · cited 10× · PMID 37465959 · DOI 10.1177/15459683231184190
3. Digitizing a Therapeutic: Development of an Augmented Reality Dual-Task Training Platform for Parkinson's Disease.
   Alberts JL, Kaya RD, Scelina K, Scelina L, et al · · 2022 · cited 7× · PMID 36433353 · DOI 10.3390/s22228756
4. Including individuals with Parkinson's disease and deep brain stimulation in rehabilitation trials: feasibility, challenges, and preliminary gait and postural stability results.
   Rosenfeldt AB, Davidson S, Kaya RD, West E, et al · · 2025 · PMID 40541059 · DOI 10.1016/j.parkreldis.2025.107920