Trial Outcomes & Findings for Dual-task Augmented Reality for PD DBS (NCT NCT06418152)

Last Updated: 2025-09-30

Results Overview

Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function. Change in MDS-UPDRS III score from baseline through completion.

Recruitment status

COMPLETED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

Baseline and through study completion, average 8 weeks

Results posted on

2025-09-30

Participant Flow

Participants were recruited beginning May 21, 2024 through December 2024.

All participants were in the same arm of this pilot study.

Participant milestones

Participant milestones
Measure	Interventional Arm Five to ten individuals with PD and DBS will receive the DART intervention. The 16 DART sessions will be delivered over an 8-week period (but not more than 10-weeks). Each DART session will consist of approximately 30-minutes of dual-task activity and will be scheduled over a 1 hour period. A physical therapist or physical therapist assistant will oversee each session. Exercises will be progressed based on results from the DART platform, feedback from the participant, and the clinical expertise of the physical therapist or physical therapist assistant Multi-modal treatment: Multi-modal treatment was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. MMT consists of simultaneously training a motor and cognitive task.
Overall Study STARTED	7
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Interventional Arm Five to ten individuals with PD and DBS will receive the DART intervention. The 16 DART sessions will be delivered over an 8-week period (but not more than 10-weeks). Each DART session will consist of approximately 30-minutes of dual-task activity and will be scheduled over a 1 hour period. A physical therapist or physical therapist assistant will oversee each session. Exercises will be progressed based on results from the DART platform, feedback from the participant, and the clinical expertise of the physical therapist or physical therapist assistant Multi-modal treatment: Multi-modal treatment was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. MMT consists of simultaneously training a motor and cognitive task.
Overall Study Frequent DBS setting changes	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Dual-task Augmented Reality for PD DBS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interventional Arm n=4 Participants Up to five individuals with PD and DBS will receive the DART intervention. The 16 DART sessions will be delivered over an 8-week period (but not more than 10-weeks). Each DART session will consist of approximately 30-minutes of dual-task activity and will be scheduled over a 1 hour period. A physical therapist or physical therapist assistant will oversee each session. Exercises will be progressed based on results from the DART platform, feedback from the participant, and the clinical expertise of the physical therapist or physical therapist assistant Multi-modal treatment: Multi-modal treatment was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. MMT consists of simultaneously training a motor and cognitive task.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	67.5 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination)	38 units on a scale STANDARD_DEVIATION 16 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and through study completion, average 8 weeks

Outcome measures

Outcome measures
Measure	Interventional Arm n=4 Participants Five to ten individuals with PD and DBS will receive the DART intervention. The 16 DART sessions will be delivered over an 8-week period (but not more than 10-weeks). Each DART session will consist of approximately 30-minutes of dual-task activity and will be scheduled over a 1 hour period. A physical therapist or physical therapist assistant will oversee each session. Exercises will be progressed based on results from the DART platform, feedback from the participant, and the clinical expertise of the physical therapist or physical therapist assistant Multi-modal treatment: Multi-modal treatment was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. MMT consists of simultaneously training a motor and cognitive task.
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score	3.25 Score on a scale Standard Deviation 3.27

SECONDARY outcome

Timeframe: Baseline and through study completion, average 8 weeks

Distance traveled during a 2 minute period under single-and dual-task conditions. Number reported is the change in distance from baseline to end of intervention.

Outcome measures

Outcome measures
Measure	Interventional Arm n=4 Participants Five to ten individuals with PD and DBS will receive the DART intervention. The 16 DART sessions will be delivered over an 8-week period (but not more than 10-weeks). Each DART session will consist of approximately 30-minutes of dual-task activity and will be scheduled over a 1 hour period. A physical therapist or physical therapist assistant will oversee each session. Exercises will be progressed based on results from the DART platform, feedback from the participant, and the clinical expertise of the physical therapist or physical therapist assistant Multi-modal treatment: Multi-modal treatment was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. MMT consists of simultaneously training a motor and cognitive task.
Two Minute Walk Test	0.06 meters/second Standard Deviation 0.15

Adverse Events

Interventional Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Interventional Arm n=7 participants at risk Five to ten individuals with PD and DBS will receive the DART intervention. The 16 DART sessions will be delivered over an 8-week period (but not more than 10-weeks). Each DART session will consist of approximately 30-minutes of dual-task activity and will be scheduled over a 1 hour period. A physical therapist or physical therapist assistant will oversee each session. Exercises will be progressed based on results from the DART platform, feedback from the participant, and the clinical expertise of the physical therapist or physical therapist assistant Multi-modal treatment: Multi-modal treatment was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. MMT consists of simultaneously training a motor and cognitive task.
Musculoskeletal and connective tissue disorders Non-serious adverse event	14.3% 1/7 • Number of events 1 • Adverse events were collected during active study participation dates. The study intervention from baseline testing to end of testing was an 8-week period, not to exceed 10-weeks. Participants were asked at each session whether any adverse events occurred since the previous session.
Injury, poisoning and procedural complications Non-serious adverse event	14.3% 1/7 • Number of events 1 • Adverse events were collected during active study participation dates. The study intervention from baseline testing to end of testing was an 8-week period, not to exceed 10-weeks. Participants were asked at each session whether any adverse events occurred since the previous session.

Additional Information

Jay Alberts, PhD

Cleveland Clinic

Phone: 216-445-3222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place