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| Name | Class |
|---|---|
| Davis Phinney Foundation | OTHER |
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The primary aim of the proposed project is to characterize dual tasking (DT) deficits to improve motor, cognitive, and quality of life outcomes in individuals with Parkinson's disease (PD). Phase 1 of the intervention will involve an in-depth gait analysis on 15 individuals with PD. This gait analysis will utilize the Computer Assisted Rehabilitation Environment (CAREN) system, a virtual reality system with a fully integrated 3-D motion capture system. The purpose of Phase 1 is to generalize characteristics of gait and postural control during specific DT conditions. Phase 2 (N=20) involves the clinical translation of these findings. This phase will involve creating a clinical intervention based on the objective information gathered the CAREN system. The intervention will take place 3x/week for a total of 8 weeks. Interventional groups will include: 1) DT clinical group (N=10) and 2) Single task group (N=10). Outcome measures will be used at the beginning and end of the intervention to assess the feasibility and efficacy of the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Task Group | Experimental | This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks. |
|
| Single Task Group | Active Comparator | This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Task Group | Behavioral | Performing motor-motor or motor-cognitive tasks at the same time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Step Length During Gait | The average distance from heel strike of the less affected leg to heel strike of the more affected leg. Higher values indicate a longer step length. | Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
| Walking Speed During Gait | Average self-selected walking speed without dual tasking. | Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 2 Minute Walk Test | A functional endurance assessment, reporting total distance traveled over a 2 minute period. Higher values indicate better functional endurance. | Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
| Quality of Life in Neurological Disorders Questionnaire |
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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 |
|---|---|---|---|
| 31648204 | Derived | Penko AL, Barkley JE, Rosenfeldt AB, Alberts JL. Multimodal Training Reduces Fall Frequency as Physical Activity Increases in Individuals With Parkinson's Disease. J Phys Act Health. 2019 Dec 1;16(12):1085-1091. doi: 10.1123/jpah.2018-0595. Epub 2019 Oct 24. | |
| 31103489 | Derived | Rosenfeldt AB, Penko AL, Streicher MC, Zimmerman NM, Koop MM, Alberts JL. Improvements in temporal and postural aspects of gait vary following single- and multi-modal training in individuals with Parkinson's disease. Parkinsonism Relat Disord. 2019 Jul;64:280-285. doi: 10.1016/j.parkreldis.2019.05.021. Epub 2019 May 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 | Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit. |
| FG001 | Phase 2: Dual Task | This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks. |
| FG002 | Phase 2: Single Task | This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Two participants (one in Phase 1 and one in Phase 2) were unable to complete the required cognitive assessments, and thus were excluded from all analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 | Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit. |
| BG001 | Phase 2: Dual Task |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Step Length During Gait | The average distance from heel strike of the less affected leg to heel strike of the more affected leg. Higher values indicate a longer step length. | Two participants (one in Phase 1 and one in Phase 2) were unable to complete the required cognitive assessments, and thus were excluded from all analyses. | Posted | Mean | Standard Deviation | meters | Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
|
Phase 1: study duration (1 day) Phase 2: study duration (an average of 13 weeks)
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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 | Phase 1 | Will collect in-depth gait assessments under single and dual task conditions. This is a non-interventional group, with all outcomes collected during a single visit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall without injury | General disorders | Systematic Assessment |
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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 | Yes | No | No | Study Protocol | Sep 6, 2016 | Jan 31, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2019 | Jan 31, 2019 | SAP_001.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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| Single Task Group | Behavioral | Performing motor or cognitive tasks alone. |
|
Quality of life questionnaire. Reported here is T-Score for the Lower Extremity domain. A T-score of 50 is the mean of the reference population, with higher scores indicating a better outcome. |
| Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
| Activities-specific Balance Confidence Scale | Balance questionnaire. Scores range from 0-100, with higher scores indicating greater balance confidence. | Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
| Trail Making Test | Cognitive task where the participant connects 25 dots in numerical order. Lower scores indicate better cognitive function. Reported here is total time to complete the task. | Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
| Reaction Time | Average time taken to react to a choice of two stimuli. Lower scores indicate better reaction time. | Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
| 31034314 | Derived | Rosenfeldt AB, Penko AL, Bazyk AS, Streicher MC, Dey T, Alberts JL. The Two Minute Walk Test Overground and on a Self-Paced Treadmill Detects Dual Task Deficits in Individuals With Parkinson's Disease. J Aging Phys Act. 2019 Dec 1;27(4):843-847. doi: 10.1123/japa.2018-0264. |
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
| BG002 | Phase 2: Single Task | This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Step Length | The average distance from heel strike of the less affected leg to heel strike of the more affected leg. | Mean | Standard Deviation | meters |
|
| Walking Speed | Average self-selected walking speed without dual tasking. | Mean | Standard Deviation | meters/second |
|
This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks.
| OG002 | Phase 2: Single Task | This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks. |
|
|
| Primary | Walking Speed During Gait | Average self-selected walking speed without dual tasking. | Two participants (one in Phase 1 and one in Phase 2) were unable to complete the required cognitive assessments, and thus were excluded from all analyses. | Posted | Mean | Standard Deviation | meters/second | Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
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| Secondary | 2 Minute Walk Test | A functional endurance assessment, reporting total distance traveled over a 2 minute period. Higher values indicate better functional endurance. | Two participants (one in Phase 1 and one in Phase 2) were unable to complete the required cognitive assessments, and thus were excluded from all analyses. | Posted | Mean | Standard Deviation | meters | Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
|
|
|
| Secondary | Quality of Life in Neurological Disorders Questionnaire | Quality of life questionnaire. Reported here is T-Score for the Lower Extremity domain. A T-score of 50 is the mean of the reference population, with higher scores indicating a better outcome. | One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses. One participant did not complete this assessment at EOT+4. | Posted | Mean | Standard Deviation | T-score | Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
|
|
|
| Secondary | Activities-specific Balance Confidence Scale | Balance questionnaire. Scores range from 0-100, with higher scores indicating greater balance confidence. | One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses. | Posted | Mean | Standard Deviation | units on a scale | Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
|
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| Secondary | Trail Making Test | Cognitive task where the participant connects 25 dots in numerical order. Lower scores indicate better cognitive function. Reported here is total time to complete the task. | One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses. One participant did not complete this assessment at EOT+4. | Posted | Mean | Standard Deviation | seconds | Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
|
|
|
| Secondary | Reaction Time | Average time taken to react to a choice of two stimuli. Lower scores indicate better reaction time. | One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses. One participant did not complete this assessment at EOT+4. | Posted | Mean | Standard Deviation | milliseconds | Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks |
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| 0 |
| 24 |
| 0 |
| 24 |
| 1 |
| 24 |
| EG001 | Phase 2: Dual Task | This group will complete an exercise intervention that involves performing dual tasking activities (simultaneously performing 2 things at once). This group will exercise 3x/wk for 8 weeks. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG002 | Phase 2: Single Task | This group will complete an exercise intervention that involves performing single task activities. The participant will perform motor tasks and cognitive tasks individually. This group will exercise 3x/wk for 8 weeks. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| End of Treatment |
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| End of Treatment+4 weeks |
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| End of Treatment |
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| End of Treatment +4 weeks |
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| End of Treatment |
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| End of Treatment +4 weeks |
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| End of Treatment +4 weeks |
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| End of Treatment |
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| End of Treatment +4 weeks |
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| End of Treatment |
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| End of Treatment +4 weeks |
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