Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized ActiveStep Comparative Effectiveness Trial
Brief Summary: The investigators are conducting a multi-center randomized prospective trial comparing a standard physical therapy gait and balance program with a gait and balance program that includes the ActiveStep™ treadmill.

Subjects will be randomized to either have the ActiveStep™ as part of their therapy or to have their therapy without it. Data will be gathered from session notes, medical records and short interviews with the subjects at baseline and every 3 months over the telephone for the duration of the study.


Options:
A: Inclusion Criteria:

* Clinical diagnosis of primary Parkinson's disease
* In a Hoehn and Yahr stage less than stage III
* Disease duration is less than 5 years
* Not likely to require dopaminergic therapy within 6 months

Exclusion Criteria:

* Use of any PD medication within 60 days prior to the beginning the study, including levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl).
* Duration of previous use of medications for PD that exceeds 90 days
* Expected to require dopaminergic therapy in the next 6 months
* Poorly controlled or unstable cardiovascular disease
* Uncontrolled hypertension
* Hypo- or hyperthyroidism, abnormal liver function, abnormal renal function
* Mild cognitive impairment (Montreal Cognitive Assessment score\<26/30)
* Depression that precludes ability to exercise (Beck depression score\>13)
* Disorders that interfere with ability to perform endurance exercises
* Regular participation in vigorous endurance exercise
* Evidence of serious arrhythmias or ischemic heart disease
* Any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study
B: Inclusion Criteria:

* Patients with idiopathic PD.
* Patients with motor fluctuations averaging at least 1 hour daily in the "OFF" state during the waking hours.
* Patients with a Modified Hoehn and Yahr stage ≤3 in the "ON" state.
* Patients taking optimised levodopa or dopa decarboxylase inhibitor (DDI) therapy; they must be stable for at least 14 days prior to baseline.
* Patients receiving at least 3 daily doses of levodopa and not more than 8 daily doses of levodopa.
* Patients who have demonstrated the ability to keep accurate "24-hour" diaries prior to randomisation.

Exclusion Criteria:

* Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation.
* Patients with a clinically significant or unstable vascular disease.
* Patients who have undergone a neurosurgical intervention of PD.
* Patients with severe disabling dyskinesias.
* Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study.
* Patients with a Mini Mental State Examination (MMSE) score ≤24.
* Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion.

Other inclusion and exclusion criteria may apply.
C: Inclusion Criteria:

* Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 years;
* Hoehn and Yahr Stage 1-3 in an "on" state;
* Require levodopa-containing medication regimen at least 3 times during the waking day;
* Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
* Are on stable PD medication regimen;
* Total daily LD dose \<1600 mg/day;
* Able to perform a spirometry maneuver in the ON and OFF states;
* Normal cognition confirmed by MMSE score ≥25

Exclusion Criteria:

* Pregnant or lactating females;
* Previous surgery for PD or plan to have stereotactic surgery during the study period;
* History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
* Known contraindication to the use of levodopa;
* Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
* Any contraindication to performing routine spirometry.
D: Inclusion Criteria:

* Age 65 and over
* Referred to physical therapy for balance training

Exclusion Criteria:

* Age \< 65
* Unable to use treadmill
* Severe vertigo
* Not a candidate for gait/balance PT
* Not competent to consent to research

Answer: D