To determine if PT intervention will be improved while in the "on" motor state vs. the "end-of-dose-off" motor state during the PT Intervention Visit in subjects with PD.
Multicenter, outpatient trial to evaluate PT outcomes in subjects diagnosed with PD and currently using APOKYN. Those subjects who satisfy all eligibility criteria will be randomized to 2 treatment groups: 1. "APO+" (APOKYN treatment before the PT Intervention Visit) and; 2. "APO-" (APOKYN treatment withheld before the PT Intervention Visit). The study will have: * Baseline Assessment Visit(s) - 1 day at Investigator's clinic and PT clinic * APOKYN Response Verification Visit - 1 day * PT Intervention Visits - for 6 weeks * End-of-study Assessment Visit(s) - 1 day at Investigator's clinic and PT clinic All subjects will participate in a standardized PT intervention. In both treatment groups, ALL subjects will arrive for the PT Intervention Visit in an "end-of-dose-off" motor state. The "end-of-dose-off" motor state will be achieved by the subject withholding his/her carbidopa/levodopa dose and APOKYN dose for at least 3 hours before the PT Intervention Visit. It is hypothesized that the outcome of PT will be improved when subjects are in the "on" motor state during PT Intervention visits compared with being in the "end-of-dose-off" motor state during PT Intervention visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
13
Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.
All subjects will participate in a standardized PT intervention
Unnamed facility
Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Loma Linda, California, United States
Unnamed facility
Change From Baseline in Activities-specific Balance Confidence (ABC) Scale
Scale from 0 to 100% where an increase in percent represents an improvement in balance confidence.
Time frame: Baseline and after week 6
Change From Baseline in Movement Disorder Societies Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination)
MDS-UPDRS Part III is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 72 (worst score possible). A negative change from baseline represents an improvement in motor function.
Time frame: Baseline and after week 6
Change From Baseline in Modified Physical Performance Test (M-PPT)
Investigator scale assessing 9 domains of physical functioning where total scores range from 0 to 28 with higher scores indicating better physical performance. A positive change from baseline represents an improvement in physical performance.
Time frame: Baseline and after week 6
Change From Baseline in Timed-Up-and-Go (TUG) Test
Test captures the amount of time for a subject to get up from an arm chair, walk 3 meters, turn around, walk back to chair, and sit. A negative change from baseline represents an improvement of physical function.
Time frame: Baseline and after week 6
Change From Baseline in 6-Minute Walk Test (6MWT)
Objective performance based measure of functional exercise capacity that measures the distance a subject can cover on a 30 meter flat walking area over 6 minutes. A positive change from baseline represents an improvement in the distance walked (ft) in 6 minutes.
Time frame: Baseline and after week 6
Change From Baseline in Montreal Cognitive Assessment (MoCA)
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Sunnyvale, California, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Foxborough, Massachusetts, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Tulsa, Oklahoma, United States
Unnamed facility
Hershey, Pennsylvania, United States
Unnamed facility
Austin, Texas, United States
...and 2 more locations
The MoCA is a validated, 30-point test (sum of the 6 domains), with scores ranging from 0 (worst) to 30 (best). The test is designed to assess several cognitive domains, including visuospatial abilities (5 points), animal naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). Total MoCA scores higher than 26 indicate normal cognitive function. A positive change from baseline represents an improvement in cognitive function.
Time frame: Baseline and after week 6
Change From Baseline in MDS-UPDRS Part I A
MDS-UPDRS Part I A is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 24 (worst score possible). A negative change from baseline represents an improvement in non-motor experiences of daily living (investigator rated).
Time frame: Baseline and after week 6
Number of Participants in Each Category of Clinical Global Impression of Change (CGI-C)
Investigator's impression of change in the subject's symptoms from baseline assessment visit to end of study assessment, on a 7-point scale ranging from very much improved to very much worse.
Time frame: After week 6
Change From Baseline in MDS-UPDRS Part II
MDS-UPDRS Part II is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 52 (worst score possible). A negative change from baseline represents an improvement in motor experience of daily living.
Time frame: Baseline and after week 6
Change From Baseline in MDS-UPDRS Part IV
MDS-UPDRS Part IV is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 24 (worst score possible). A negative change from baseline represents fewer motor complications.
Time frame: Baseline and after week 6
Change From Baseline in MDS-UPDRS Part I B
MDS-UPDRS Part I B is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 28 (worst score possible). A negative change from baseline represents an improvement in non-motor experiences of daily living (subject rated).
Time frame: Baseline and after week 6
Change From Baseline in Clinical Global Impression of Severity (CGI-S)
Investigator's impression of the severity of the subject's illness on a 7-point scale ranging from normal (1) to among the most extremely ill subjects (7). A negative change from baseline represents a decrease in the severity of the subject's illness.
Time frame: Baseline and after week 6