Parkinson Disease
Conditions
Keywords
Parkinson disease, dual task, postural instability, gait dysfunction
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAugmented Reality Multi-Modal Training
Training administered via an augmented reality headset.
BEHAVIORALTraditional Multi-Modal Training
Training administered via a 1:1 physical therapy session
Sponsors
Michael J. Fox Foundation for Parkinson's Research
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The investigator performing the assessments will be blinded to group allocation.
Intervention model description
50 individuals with Parkinson's disease will be randomized to either 1) traditional multi-modal training, or 2) augmented reality multi-modal training.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult with a diagnosis of idiopathic PD 2. Self-reported gait or balance deficits 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Velocity | 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 |
| MDS-UPDRS III Score | 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. |
| Fall Frequency | From baseline assessment to the end of the 8-week training session | number of falls in the previous 30 day period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 24 |
| 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. | 27 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Traditional Multi-Modal Training | Augmented Reality Multi-Modal Training | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 22 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Continuous | 68.4 years STANDARD_DEVIATION 6.1 | 69.9 years STANDARD_DEVIATION 6.2 | 69.2 years STANDARD_DEVIATION 6.1 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 21 Participants | 23 Participants | 44 Participants |
| Region of Enrollment United States | 24 participants | 27 participants | 51 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 16 Participants | 22 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 27 |
| other Total, other adverse events | 0 / 24 | 1 / 27 |
| serious Total, serious adverse events | 0 / 24 | 1 / 27 |
Outcome results
Primary
Fall Frequency
number of falls in the previous 30 day period
Time frame: From baseline assessment to the end of the 8-week training session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Multi-Modal Training | Fall Frequency | Baseline Number of falls | 0.5 number of falls | Standard Deviation 1.22 |
| Traditional Multi-Modal Training | Fall Frequency | End of Treatment Number of Falls | 0.64 number of falls | Standard Deviation 1.59 |
| Augmented Reality Multi-Modal Training | Fall Frequency | Baseline Number of falls | 0.68 number of falls | Standard Deviation 1.14 |
| Augmented Reality Multi-Modal Training | Fall Frequency | End of Treatment Number of Falls | 0.52 number of falls | Standard Deviation 0.71 |
Primary
Gait Velocity
Walking speed (m/s) on a self-paced treadmill during single and dual task conditions
Time frame: From baseline assessment to the end of the 8-week training session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Multi-Modal Training | Gait Velocity | Baseline Single-task Walk Speed | 1.20 meters/second | Standard Error 0.19 |
| Traditional Multi-Modal Training | Gait Velocity | Baseline Serial 7 Dual-Task Walk Speed | 1.03 meters/second | Standard Error 0.24 |
| Traditional Multi-Modal Training | Gait Velocity | Baseline Digit Recall Dual-Task Walk Speed | 1.05 meters/second | Standard Error 0.18 |
| Traditional Multi-Modal Training | Gait Velocity | Baseline Controlled Oral Word Association Dual-Task Walk Speed | 1.09 meters/second | Standard Error 0.19 |
| Traditional Multi-Modal Training | Gait Velocity | Baseline Stroop Dual-Task Walk Speed | 1.11 meters/second | Standard Error 0.23 |
| Traditional Multi-Modal Training | Gait Velocity | Baseline 1-Back Dual-Task Walk Speed | 1.07 meters/second | Standard Error 0.27 |
| Traditional Multi-Modal Training | Gait Velocity | Baseline 2-Back Dual-Task Walk Speed | 1.08 meters/second | Standard Error 0.27 |
| Traditional Multi-Modal Training | Gait Velocity | End of Treatment Single-task Walk | 1.27 meters/second | Standard Error 0.19 |
| Traditional Multi-Modal Training | Gait Velocity | End of Treatment Serial 7 Dual-Task Walk Speed | 1.12 meters/second | Standard Error 0.23 |
| Traditional Multi-Modal Training | Gait Velocity | End of Treatment Digit Recall Dual-Task Walk Speed | 1.14 meters/second | Standard Error 0.22 |
| Traditional Multi-Modal Training | Gait Velocity | End of Treatment Controlled Oral Word Association Dual-Task Walk Speed | 1.17 meters/second | Standard Error 0.21 |
| Traditional Multi-Modal Training | Gait Velocity | End of Treatment Stroop Dual-Task Walk Speed | 1.19 meters/second | Standard Error 0.25 |
| Traditional Multi-Modal Training | Gait Velocity | End of Treatment 1-Back Dual-Task Walk Speed | 1.18 meters/second | Standard Error 0.26 |
| Traditional Multi-Modal Training | Gait Velocity | End of Treatment 2-Back Dual-Task Walk Speed | 1.17 meters/second | Standard Error 0.29 |
| Augmented Reality Multi-Modal Training | Gait Velocity | End of Treatment Controlled Oral Word Association Dual-Task Walk Speed | 1.22 meters/second | Standard Error 0.29 |
| Augmented Reality Multi-Modal Training | Gait Velocity | Baseline Single-task Walk Speed | 1.22 meters/second | Standard Error 0.2 |
| Augmented Reality Multi-Modal Training | Gait Velocity | End of Treatment Single-task Walk | 1.33 meters/second | Standard Error 0.25 |
| Augmented Reality Multi-Modal Training | Gait Velocity | Baseline Serial 7 Dual-Task Walk Speed | 1.07 meters/second | Standard Error 0.29 |
| Augmented Reality Multi-Modal Training | Gait Velocity | End of Treatment 1-Back Dual-Task Walk Speed | 1.25 meters/second | Standard Error 0.3 |
| Augmented Reality Multi-Modal Training | Gait Velocity | Baseline Digit Recall Dual-Task Walk Speed | 1.09 meters/second | Standard Error 0.23 |
| Augmented Reality Multi-Modal Training | Gait Velocity | End of Treatment Serial 7 Dual-Task Walk Speed | 1.22 meters/second | Standard Error 0.31 |
| Augmented Reality Multi-Modal Training | Gait Velocity | Baseline Controlled Oral Word Association Dual-Task Walk Speed | 1.11 meters/second | Standard Error 0.24 |
| Augmented Reality Multi-Modal Training | Gait Velocity | End of Treatment Stroop Dual-Task Walk Speed | 1.27 meters/second | Standard Error 0.29 |
| Augmented Reality Multi-Modal Training | Gait Velocity | Baseline Stroop Dual-Task Walk Speed | 1.19 meters/second | Standard Error 0.25 |
| Augmented Reality Multi-Modal Training | Gait Velocity | End of Treatment Digit Recall Dual-Task Walk Speed | 1.22 meters/second | Standard Error 0.29 |
| Augmented Reality Multi-Modal Training | Gait Velocity | Baseline 1-Back Dual-Task Walk Speed | 1.11 meters/second | Standard Error 0.27 |
| Augmented Reality Multi-Modal Training | Gait Velocity | End of Treatment 2-Back Dual-Task Walk Speed | 1.22 meters/second | Standard Error 0.33 |
| Augmented Reality Multi-Modal Training | Gait Velocity | Baseline 2-Back Dual-Task Walk Speed | 1.09 meters/second | Standard Error 0.29 |
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.
Time frame: From baseline assessment to the end of the 8-week training session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Multi-Modal Training | MDS-UPDRS III Score | Baseline MDS-UPDRS III Score | 34.1 score on a scale | Standard Deviation 13.1 |
| Traditional Multi-Modal Training | MDS-UPDRS III Score | End of Treatment MDS-UPDRS III Score | 34.9 score on a scale | Standard Deviation 11.4 |
| Augmented Reality Multi-Modal Training | MDS-UPDRS III Score | Baseline MDS-UPDRS III Score | 37.6 score on a scale | Standard Deviation 12.3 |
| Augmented Reality Multi-Modal Training | MDS-UPDRS III Score | End of Treatment MDS-UPDRS III Score | 36.6 score on a scale | Standard Deviation 12.8 |