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| Name | Class |
|---|---|
| Michael J. Fox Foundation for Parkinson's Research | OTHER |
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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.
Individuals with Parkinson's disease who qualify for the study will come to the Cleveland Clinic for an informed consent visit. At the informed consent visit, the participant will receive an activity monitor and a fall diary. Following a 4-week period where activity and falls are monitored, the participant will come to the Cleveland Clinic for a comprehensive physical and cognitive assessment primarily using a virtual reality treadmill system. During that baseline assessment, the individual will be randomized to either 1) traditional multi-modal training, or 2) augmented reality multi-modal training. Regardless of group allocation, the participant will complete a total of 16 treatment sessions (2x/week for 8 weeks). The traditional multi-modal treatment will be administered 1:1 by a physical therapist. The augmented reality multi-modal training will be overseen by a physical therapist and administered via the Microsoft HoloLens 2 augmented reality device. Follow-up assessments will be conducted at the end of the 16 treatment sessions and 8 weeks after the treatment sessions have ceased. Falls and activity data will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Multi-Modal Training | Active Comparator | A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions) |
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| Augmented Reality Multi-Modal Training | Experimental | Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented Reality Multi-Modal Training | Behavioral | Training administered via an augmented reality headset. |
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| Measure | Description | Time Frame |
|---|---|---|
| Gait Velocity | Walking speed (m/s) on a self-paced treadmill during single and dual task conditions | From baseline assessment to the end of the 8-week training session |
| MDS-UPDRS III Score | 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. | From baseline assessment to the end of the 8-week training session |
| Fall Frequency | number of falls in the previous 30 day period | From baseline assessment to the end of the 8-week training session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Alberts, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37465959 | Derived | Alberts JL, Kaya RD, Penko AL, Streicher M, Zimmerman EM, Davidson S, Walter BL, Rosenfeldt AB. A Randomized Clinical Trial to Evaluate a Digital Therapeutic to Enhance Gait Function in Individuals With Parkinson's Disease. Neurorehabil Neural Repair. 2023 Sep;37(9):603-616. doi: 10.1177/15459683231184190. Epub 2023 Jul 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Traditional Multi-Modal Training | A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions) Traditional Multi-Modal Training: Training administered via a 1:1 physical therapy session |
| FG001 | Augmented Reality Multi-Modal Training | Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist. Augmented Reality Multi-Modal Training: Training administered via an augmented reality headset. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Traditional Multi-Modal Training | A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions) Traditional Multi-Modal Training: Training administered via a 1:1 physical therapy session |
| BG001 |
| 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 | Gait Velocity | Walking speed (m/s) on a self-paced treadmill during single and dual task conditions | Posted | Mean | Standard Error | meters/second | From baseline assessment to the end of the 8-week training session |
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Adverse events were collected over the 5 month study enrollment for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Traditional Multi-Modal Training | A physical therapist will provide 1:1 multi-modal training. Multi-modal training is the simultaneous performance of a motor and a cognitive task (i.e. marching while answering math questions) Traditional Multi-Modal Training: Training administered via a 1:1 physical therapy session |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant fell during training session. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment | Participant fell during training session. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jay Alberts | Cleveland Clinic | 216 445-3222 | albertj@ccf.org |
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| 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 | Jan 30, 2020 | Oct 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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50 individuals with Parkinson's disease will be randomized to either 1) traditional multi-modal training, or 2) augmented reality multi-modal training.
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The investigator performing the assessments will be blinded to group allocation.
| Traditional Multi-Modal Training | Behavioral | Training administered via a 1:1 physical therapy session |
|
| Augmented Reality Multi-Modal Training |
Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist. Augmented Reality Multi-Modal Training: Training administered via an augmented reality headset. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Primary | MDS-UPDRS III Score | 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. | Posted | Mean | Standard Deviation | score on a scale | From baseline assessment to the end of the 8-week training session |
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| Primary | Fall Frequency | number of falls in the previous 30 day period | Posted | Mean | Standard Deviation | number of falls | From baseline assessment to the end of the 8-week training session |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Augmented Reality Multi-Modal Training | Multi-modal training will be administered via the Microsoft HoloLens 2 augmented reality head set. Augmented reality allows user to see the real world, and inserts holograms into the environment. For example, the user could see boxes on the ground that they need to step around when walking. The boxes are not real, but rather a hologram that only the user can see. The augmented reality device will instruct the participant on the motor and cognitive task that should be performed simultaneously in a similar manner to the physical therapist in the traditional multi-modal training group. The intervention will be overseen by a physical therapist. Augmented Reality Multi-Modal Training: Training administered via an augmented reality headset. | 0 | 27 | 1 | 27 | 1 | 27 |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |