Dual-task Augmented Reality Treatment for Parkinson's Disease (DART)
Phase: PHASE2
Conditions: Parkinson Disease
Sponsor: The Cleveland Clinic

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ClinicalTrial.gov Final Outcomes Report 
 
 
 
 
NCT Number: 
04634331 
Project Title: 
Dual-Task Augmented Reality Treatment for Parkinson’s 
Disease 
Principal Investigator Name: 
Jay L. Alberts, PhD 
Principal Investigator 
Organization and Address: 
Cleveland Clinic 
9500 Euclid Ave. 
Cleveland, OH 44195 
Principal Investigator 
Phone and Email: 
albertj@ccf.org 
216-445-3222 
Report Date: 
10/10/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TITLE: Dual-task Augmented Reality Treatment (DART) for Parkinson’s disease 
PI: Jay Alberts, PhD 
DATE MODIFIED: 1/30/2020 
 
Project Goal: 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.   
 
Rationale: Postural instability is a cardinal motor symptom of Parkinson’s disease (PD), and is 
often accompanied with non-motor symptoms such as cognitive impairment.1 Activities of daily 
living (ADL) frequently involve the simultaneous performance of two or more tasks, such as 
crossing the street while holding a conversation. The cognitive demands of dual-tasking to 
perform routine daily activities may lead to increased fall rates relative to healthy peers.2 
 
Multi-Modal Training in PD patients:  Based on the clear link between cognitive errors and gait 
instability,3,4 multi-modal treatment (MMT)3 was designed to target PD specific declines in these 
areas of cognitive function and specific gait and posture impairments, such as turning.5,6  Briefly, 
MMT training consists of simultaneously training gait and cognition over the course of a 45-
minute therapy session.  The motor aspect of MMT stresses high velocity, high amplitude training 
principles with an external focus of attention (i.e. high knee marching, large amplitude stepping to 
targets, increase gait speed, turning, etc).7  Considering our recent findings indicating attention 
and problem solving are particularly impactful on gait performance,8 the cognitive aspect of MMT 
stressed these functions by asking patients to spell words backwards (i.e. progress from “cat” to 
“television”) and solve math problems (i.e. progress from “5-2=_” to “3+3+9-11=_”).   
 
Multi-Modal Training Improves Gait, Cognition, and Reduces Falls in PD patients: In 2015-
27, we conducted a preliminary RCT trial was completed in which MMT was compared to single-
modal training (SMT) (i.e. sequential practice of cognitive and motor tasks).3  There was an 
interaction effect favoring the MMT group with arm swing amplitude and Serial 7 responses, 
suggesting that MMT training may be better than SMT training in select motor and cognitive 
performance.3  Results indicate that 8 weeks of MMT resulted in a significant reduction in fall 
frequency in PD patients compared to those in the SMT group whose fall rates remained 
unchanged.9   
 
Delivery of a Digital Therapeutic via Augmented Reality for the Treatment of PIGD: The 
MMT intervention is well-suited for integration into an augmented reality (AR) platform as it 
consists of the patient performing a series of cognitive and motor tasks simultaneously while the 
patient receives knowledge of performance and results from a therapist. The Microsoft HoloLens 
is an untethered, AR headset used in applications as broad as teaching anatomy, displaying fine 
art and gaming. With AR, the user maintains contact with the physical world and the people in it. 
The HoloLens uses AR technology to place holograms, objects made entirely of projected light, 
into the user’s physical environment; hence creating a first-person mixed reality environment.  
These holograms can be viewed from different angles and distances, can be two-dimensional or 
three-dimensional, can appear life-like, can move, be shaped, and change according to 
interaction with users’ or the physical environment in which they are projected, depending on the 
programming. For this study, we will codify the MMT therapy into the DART protocol to create an 
augmented reality application for use with the HoloLens 2.   

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APPROACH: We will conduct a RCT comparing 
the DART protocol with traditional MMT 
administered by a therapist. It is hypothesized 
that the DART and therapist-led interventions will 
be similar in improving lower extremity function 
and reducing 30-day fall rates. A study flow 
diagram is provided in Figure 1.  A total of 50 PD 
patients, with a history of falls, will be 
randomized to the traditional MMT (n=25) or 
DART (n=25) groups.   
 
Inclusion criteria: 
1) Adult with a diagnosis of idiopathic PD 
2) History of at least 2 falls in the past six-
months 
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,10  
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 
6) Cardiac arrhythmia  
   
Randomization: Participants will be randomized via a RedCap randomization database. The 
study team has ample experience with the RedCap randomization process, as they are using it 
for an ongoing, NIH, multi-site trial. 
 
DART Platform and Intervention: Patients randomized to the DART group will be asked to 
complete 16 sessions (2x per week for 8 weeks) with the HoloLens version of the MMT protocol 
(e.g. simultaneously completing functional and cognitive based tasks that are progressively 
increased in difficulty based on biometric outcomes). Two initial familiarization sessions with a 
physical therapist (PT) will be completed with the DART protocol; the remaining 14 sessions will 
be largely self-administered by the participant without direct supervision from a PT. Considering 
this is the first effort to evaluate an AR digital therapeutic for the treatment of PIGD in PD, 
additional precautions will be undertaken to ensure patient safety and integrity and completeness 
of data.  The DART protocol is designed to be self-administered by the patient, however, all 
training will take place in the Alberts lab and Dr. Rosenfeldt, a neurologically trained physical 
therapist, will be present to address any potential technical issues and to ensure the safety of the 
patient.  Based on performance and completion rates of the assigned modules, Drs. Rosenfeldt 
and Alberts will progress the complexity of training.  
 
MMT Intervention: Patients in the therapist-led group will attend in clinic one-on-one MMT 
sessions with a licensed PT (Dr. Rosenfeldt).  She will deliver the MMT intervention over 8 weeks 
(twice per week) using the exact model she used in our recent RCT.3     
 
Figure 1:  Study flow diagram. 

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Data Collection: Three assessments of motor and non-motor function will be completed for all 
participants: enrollment, EOT, and EOT + 8 weeks; the primary motor and non-motor outcomes 
are identical to those from our clinical trial3 and are provided in Table 1. To most closely resemble 
daily life, assessments will be conducted in the “on-medication” state (PD medication 1 hour prior 
to testing). Med-reconciliation will be completed at each assessment and levodopa equivalent 
daily doses (LEDDs) will be determined. Demographic variables will be recorded in RedCap 
 
 
Our primary outcomes are gait velocity, MDS-UPDRS III scores, and 30-day fall rate. 
Gait parameters will be evaluated for all participants using the Computer Assisted Rehabilitation 
Environment (CAREN) system (Motekforce Link, Netherlands). To assess baseline cognitive 
function over a range of cognitive domains, a series of cognitive tests will be administered in a 
seated position in random order: N-back (working memory), Serial 7 subtraction (attention), Digit 
Recall (working memory), Controlled Oral Word Association (COWA, verbal fluency), and visual 
Stroop test (executive function). The cognitive test will then be administered during gait to assess 
the effects of DART and MMT on dual-task motor and cognitive performance. The MDS-UPDRS 
III is a global scale of motor function for PD.11 Fall history will be gathered retrospectively over a 
30-day period prior to baseline, over the last 30 days of the intervention, and 30 days prior to the 
8-week follow-up evaluation.  
  
Secondary outcomes are listed in Table 2. Spatiotemporal gait variables will be collected 
on the CAREN system similarly to our previous studies.3,8,12 Postural sway will be recorded from 
the force platforms of the CAREN system. Consistent with our previous PD studies, we will use 
an instrumented TUG to determine transfer, gait, and turning variables.5,6 The same cognitive 
tasks that were conducted on the CAREN system, will be administered in a seated position to 
assess cognition alone. The difference in cognitive performance between single- and dual-task 
conditions will be used to assess dual task loss. The System Usability Scale will be used to 
determine the usability of the HoloLens system and DART protocol at the end of the intervention 
period for those who were randomized to the DART group. The System Usability Scale was 
successfully used by Meldrum and colleagues when assessing virtual reality in a novel 
Table 1: Primary and Secondary Outcome Measures 
Primary Outcome 
Description 
Gait velocity  
Self-selected walking speed on the CAREN 
system during single- and dual-task conditions 
MDS-UPDRS III 
Clinical assessment of PD motor symptoms 
30-day fall rate 
Fall history 
Secondary Outcome 
Description 
Spatiotemporal gait variables  
Ex: Cadence, step length, step width, arm swing 
on the CAREN system during single- and dual-
task conditions 
Postural sway  
Measure of balance on the CAREN system during 
single- and dual-task conditions 
Timed-Up-and-Go (TUG) 
Total trial time, turning velocity and duration under 
single- and dual-task conditions 
Cognitive performance  
During single- and dual-task conditions 
PIGD items of MDS-UPDRS III (items 9-13) 
Gait and posture 
System Usability Scale 
Usability of HoloLens and DART protocol 
technology.  
Activities-specific balance confidence scale (ABC) 
Balance confidence during daily tasks 
Neuro-QOL 
Quality of life scale for individuals with 
neurological disease 

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setting.13,14 The Neuro-QOL and ABC scale will be used as self-administered questionnaires to 
measure quality of life and balance confidence, respectively.   
  
Power and Statistical Analysis:  The primary outcomes for both groups will be the number of 
falls over the course of 30 days, MDS-UPDRS III scores, and gait velocity during dual-task 
conditions from baseline to EOT and EOT + 8 weeks. Biomechanical data will be gathered using 
the same paradigm as our clinical trial3 with the CAREN system in the Alberts’ laboratory.3,8,12,15,16 
Statistical models will include time (3-levels baseline, EOT, EOT+8) and group (2 levels - DART 
and therapist-led MMT) and their interaction. Criterion for equivalency is 1) both interventions 
show significant improvements between baseline and EOT time points and 2) the improvement in 
primary outcomes measures from the DART intervention is within 10% of the therapist-led MMT. 
A power analysis was performed using data from our previous therapist-led MMT,3,9 where the 
effect was reduced by 10% in the biomechanical and fall frequency outcome measures. Results 
indicated a sample size of N=17-30 in each group was required to achieve a power of 70-80% at 
a significance level of 5% (alpha=0.05) (RStduio 2017-power-paired-test)17; therefore we selected 
N=25 for each group to achieve a power of 80%.  
 
 
 
 
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