Parkinson's Disease
Conditions
Keywords
Dual tasking
Brief summary
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.
Interventions
BEHAVIORALDual Task Group
Performing motor-motor or motor-cognitive tasks at the same time.
BEHAVIORALSingle Task Group
Performing motor or cognitive tasks alone.
Sponsors
Davis Phinney Foundation
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of idiopathic PD * Able to provide informed consent * Ability to ambulate ≥ 300ft with or without an assistive device * Hoehn and Yahr stage 2-4
Exclusion criteria
* Undergone any surgical procedure for the treatment of PD, such as deep brain stimulation * Those who are considered to be high risk exercisers per American College of Sports Medicine exercise screening questionnaire * Musculoskeletal injury or neurological injury other than PD that would restrict physical activity * Inability to follow 2 step commands * Significant cognitive impairment as designated by ≥ 3 errors on the Short Portable Mental Status Questionnaire
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Step Length During Gait | Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks | 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. |
| Walking Speed During Gait | Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks | Average self-selected walking speed without dual tasking. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activities-specific Balance Confidence Scale | Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks | Balance questionnaire. Scores range from 0-100, with higher scores indicating greater balance confidence. |
| 2 Minute Walk Test | Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks | A functional endurance assessment, reporting total distance traveled over a 2 minute period. Higher values indicate better functional endurance. |
| Reaction Time | Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks | Average time taken to react to a choice of two stimuli. Lower scores indicate better reaction time. |
| Trail Making Test | Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks | 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. |
| Quality of Life in Neurological Disorders Questionnaire | Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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. | 10 |
| 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. | 10 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | unable to complete cognitive assessments | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Phase 1 | Phase 2: Dual Task | Phase 2: Single Task | Total |
|---|---|---|---|---|
| Age, Continuous | 63.61 years STANDARD_DEVIATION 7 | 58.90 years STANDARD_DEVIATION 8.5 | 64.60 years STANDARD_DEVIATION 8.46 | 62.74 years STANDARD_DEVIATION 7.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 10 Participants | 9 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 10 Participants | 9 Participants | 42 Participants |
| Region of Enrollment United States | 23 participants | 10 participants | 10 participants | 44 participants |
| Sex: Female, Male Female | 12 Participants | 5 Participants | 1 Participants | 18 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 9 Participants | 25 Participants |
| Step Length | 0.57 meters STANDARD_DEVIATION 0.14 | 0.63 meters STANDARD_DEVIATION 0.15 | 0.54 meters STANDARD_DEVIATION 0.15 | 0.58 meters STANDARD_DEVIATION 0.14 |
| Walking Speed | 1.24 meters/second STANDARD_DEVIATION 0.14 | 1.19 meters/second STANDARD_DEVIATION 0.34 | 1.00 meters/second STANDARD_DEVIATION 0.27 | 1.18 meters/second STANDARD_DEVIATION 0.14 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 1 / 24 | 1 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 24 | 0 / 10 | 0 / 11 |
Outcome results
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.
Time frame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 | Step Length During Gait | Baseline | 0.57 meters | Standard Deviation 0.14 |
| Phase 2: Dual Task | Step Length During Gait | End of Treatment+4 weeks | 0.71 meters | Standard Deviation 0.12 |
| Phase 2: Dual Task | Step Length During Gait | End of Treatment | 0.72 meters | Standard Deviation 0.12 |
| Phase 2: Dual Task | Step Length During Gait | Baseline | 0.63 meters | Standard Deviation 0.15 |
| Phase 2: Single Task | Step Length During Gait | End of Treatment | 0.66 meters | Standard Deviation 0.17 |
| Phase 2: Single Task | Step Length During Gait | Baseline | 0.54 meters | Standard Deviation 0.15 |
| Phase 2: Single Task | Step Length During Gait | End of Treatment+4 weeks | 0.67 meters | Standard Deviation 0.16 |
Primary
Walking Speed During Gait
Average self-selected walking speed without dual tasking.
Time frame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 | Walking Speed During Gait | Baseline | 1.24 meters/second | Standard Deviation 0.21 |
| Phase 2: Dual Task | Walking Speed During Gait | End of Treatment | 1.41 meters/second | Standard Deviation 0.3 |
| Phase 2: Dual Task | Walking Speed During Gait | Baseline | 1.19 meters/second | Standard Deviation 0.34 |
| Phase 2: Dual Task | Walking Speed During Gait | End of Treatment+4 weeks | 1.39 meters/second | Standard Deviation 0.3 |
| Phase 2: Single Task | Walking Speed During Gait | Baseline | 1.00 meters/second | Standard Deviation 0.27 |
| Phase 2: Single Task | Walking Speed During Gait | End of Treatment+4 weeks | 1.29 meters/second | Standard Deviation 0.37 |
| Phase 2: Single Task | Walking Speed During Gait | End of Treatment | 1.25 meters/second | Standard Deviation 0.35 |
Secondary
2 Minute Walk Test
A functional endurance assessment, reporting total distance traveled over a 2 minute period. Higher values indicate better functional endurance.
Time frame: Phase 1: baseline; Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 | 2 Minute Walk Test | Baseline | 158.10 meters | Standard Deviation 25.98 |
| Phase 2: Dual Task | 2 Minute Walk Test | Baseline | 135.28 meters | Standard Deviation 21.33 |
| Phase 2: Dual Task | 2 Minute Walk Test | End of Treatment | 147.53 meters | Standard Deviation 22.3 |
| Phase 2: Dual Task | 2 Minute Walk Test | End of Treatment +4 weeks | 143.77 meters | Standard Deviation 20.35 |
| Phase 2: Single Task | 2 Minute Walk Test | Baseline | 134.94 meters | Standard Deviation 35.19 |
| Phase 2: Single Task | 2 Minute Walk Test | End of Treatment | 140.15 meters | Standard Deviation 33.18 |
| Phase 2: Single Task | 2 Minute Walk Test | End of Treatment +4 weeks | 139.27 meters | Standard Deviation 31.79 |
Secondary
Activities-specific Balance Confidence Scale
Balance questionnaire. Scores range from 0-100, with higher scores indicating greater balance confidence.
Time frame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Population: One participant in Phase 2 was unable to complete the required cognitive assessments, and thus was excluded from all analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 | Activities-specific Balance Confidence Scale | Baseline | 78.44 units on a scale | Standard Deviation 19.34 |
| Phase 1 | Activities-specific Balance Confidence Scale | End of Treatment | 83.69 units on a scale | Standard Deviation 16.92 |
| Phase 1 | Activities-specific Balance Confidence Scale | End of Treatment +4 weeks | 83.81 units on a scale | Standard Deviation 11.19 |
| Phase 2: Dual Task | Activities-specific Balance Confidence Scale | End of Treatment | 76.44 units on a scale | Standard Deviation 18.64 |
| Phase 2: Dual Task | Activities-specific Balance Confidence Scale | Baseline | 75.44 units on a scale | Standard Deviation 22.94 |
| Phase 2: Dual Task | Activities-specific Balance Confidence Scale | End of Treatment +4 weeks | 79.38 units on a scale | Standard Deviation 15.9 |
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.
Time frame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 | Quality of Life in Neurological Disorders Questionnaire | Baseline | 43.84 T-score | Standard Deviation 5.85 |
| Phase 1 | Quality of Life in Neurological Disorders Questionnaire | End of Treatment | 45.76 T-score | Standard Deviation 5.95 |
| Phase 1 | Quality of Life in Neurological Disorders Questionnaire | End of Treatment +4 weeks | 46.14 T-score | Standard Deviation 5.96 |
| Phase 2: Dual Task | Quality of Life in Neurological Disorders Questionnaire | Baseline | 44.84 T-score | Standard Deviation 7.69 |
| Phase 2: Dual Task | Quality of Life in Neurological Disorders Questionnaire | End of Treatment | 44.17 T-score | Standard Deviation 8.1 |
| Phase 2: Dual Task | Quality of Life in Neurological Disorders Questionnaire | End of Treatment +4 weeks | 45.85 T-score | Standard Deviation 7.99 |
Secondary
Reaction Time
Average time taken to react to a choice of two stimuli. Lower scores indicate better reaction time.
Time frame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 | Reaction Time | End of Treatment +4 weeks | 532.49 milliseconds | Standard Deviation 88.21 |
| Phase 1 | Reaction Time | Baseline | 533.50 milliseconds | Standard Deviation 83.85 |
| Phase 1 | Reaction Time | End of Treatment | 510.24 milliseconds | Standard Deviation 70.94 |
| Phase 2: Dual Task | Reaction Time | End of Treatment +4 weeks | 558.55 milliseconds | Standard Deviation 197.19 |
| Phase 2: Dual Task | Reaction Time | Baseline | 513.44 milliseconds | Standard Deviation 129.78 |
| Phase 2: Dual Task | Reaction Time | End of Treatment | 535.76 milliseconds | Standard Deviation 119.62 |
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.
Time frame: Phase 2: baseline, end of treatment (8 weeks), and end of treatment +4 weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 | Trail Making Test | Baseline | 31.15 seconds | Standard Deviation 13.99 |
| Phase 1 | Trail Making Test | End of Treatment | 28.82 seconds | Standard Deviation 8.07 |
| Phase 1 | Trail Making Test | End of Treatment +4 weeks | 30.18 seconds | Standard Deviation 11.68 |
| Phase 2: Dual Task | Trail Making Test | End of Treatment | 38.44 seconds | Standard Deviation 20.44 |
| Phase 2: Dual Task | Trail Making Test | Baseline | 40.72 seconds | Standard Deviation 28.22 |
| Phase 2: Dual Task | Trail Making Test | End of Treatment +4 weeks | 41.57 seconds | Standard Deviation 25.37 |