Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this project is to evaluate the safety and preliminary 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 with a previously implanted deep brain stimulator (DBS).
Multi-Modal Training in PD patients: In order to treat dual-task impairment (difficulty performing two tasks at once), multi-modal treatment (MMT) was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. Briefly, MMT training consists of simultaneously training a motor and cognitive task. The motor aspect of MMT stresses high velocity, high amplitude training principles while the cognitive aspect stresses commonly impaired cognitive domains in PD such as attention and executive function. An example of an MMT task is marching while spelling words backwards.
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. The MMT was previously developed for the Dual-task Augmented Reality Treatment (DART), which delivers MMT training on a head-mounted AR display. The DART platform was successfully piloted in 50 individuals with PD who did not have DBS (IRB # 20-207). The results of the project indicate that DART is an effective method of training for individuals with PD. The goal is to expand the impact of that project through the investigation of DART in individuals with PD who have previously undergone DBS surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Arm | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-modal treatment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score | 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. | Baseline and through study completion, average 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Two Minute Walk Test | 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. | Baseline and through study completion, average 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Medical diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent
->2 errors on the Short Portable Mental Status Questionnaire
Musculoskeletal or cardiopulmonary issue that limits one's ability to engage in exercise
Neurological disease other than Parkinson's disease that impacts motor or cognitive function
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
All participants were in the same arm of this pilot study.
Participants were recruited beginning May 21, 2024 through December 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Interventional Arm | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and through study completion, average 8 weeks |
|
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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-serious adverse event | Musculoskeletal and connective tissue disorders | Systematic Assessment | Back pain, potentially related to study participation |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jay Alberts, PhD | Cleveland Clinic | 216-445-3222 | albertj@ccf.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2024 | Aug 22, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
5 to 10 individuals with previously implanted deep brain stimulation and Parkinson's disease
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination) | 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. | Mean | Standard Deviation | units on a scale |
|
|
|
| Secondary | Two Minute Walk Test | 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. | Posted | Mean | Standard Deviation | meters/second | Baseline and through study completion, average 8 weeks |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 2 |
| 7 |
|
| Non-serious adverse event | Injury, poisoning and procedural complications | Systematic Assessment | Fall during study intervention. |
|
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |