Please select the eligibility criteria that correspond to the clinical trial below.
Title: V-TIME: A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults, Patients With Parkinson's Disease and Individuals With Mild Cognitive Impairments
Brief Summary: The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk.

300 older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training.


Options:
A: Inclusion Criteria:

1. diagnosis of Parkinson disease
2. at least grade 3/5 strength and normal joint ranges of motion in both legs,
3. vision corrected to 20/40 or better,
4. able to walk independently for 10 feet with or without an assistive device, 5) normal gross somatosensory function in the feet (2-point discrimination, vibration, joint kinesthesia, and light touch),

6) no history of vestibular disease, 7) no evidence of dementia

Exclusion Criteria:

1. medical condition for which exercise is contraindicated,
2. evidence of abnormality other than PD-related changes on brain imaging,
3. history or evidence of neurological deficit other than PD that could interfere, such as previous stroke or muscle disease,
4. history or evidence of orthopedic or muscular problem,
5. failed to pass magnetic resonance imaging screening procedure
B: Inclusion Criteria:

* have a diagnosis of idiopathic Parkinson's disease (using UK Brain Bank Criteria)
* have a Hoehn \& Yahr stage of 2-4 during the "ON" state
* Mini mental status score \> 26
* be 40 years of age or older, so as to represent the typical age range of PD
* be on a stable dose of Parkinson's medications for at least 2 weeks prior to study onset and during the 3 month study period.
* have experienced at least one fall in the past 3 months and greater or equal to 2 falls in the past one-year (A fall was defined as an unexpected event where the person inadvertently came to rest on the ground or other lower level not due to a major intrinsic or extrinsic event)
* able to walk without physical assistance or an assistive device for at least 5 continuous minutes
* able to understand, communicate with and be understood by recruitment personnel
* able to attend the exercise program twice per week at Sargent College
* be interested in participating and provide informed consent

Exclusion Criteria:

* have a diagnosis of atypical Parkinsonism
* have a Hoehn \& Yahr stage of 1 or 5
* have had previous surgical management of PD (i.e., deep brain stimulation surgery; pallidotomy)
* serious co-morbidities that may interfere with ability to participate in an exercise program (i.e., musculoskeletal, cardiovascular, and neurological (other than Parkinson's))
* be pregnant
C: Inclusion Criteria:

* 2 or more falls within 6 months prior to the beginning of the study
* Aged 60-85 years
* Able to walk for 5 minutes unassisted
* Adequate hearing and vision capabilities.
* Stable medication for the past 1 month and anticipated over a period of 6 months

Exclusion Criteria:

* Psychiatric co-morbidity
* Clinical diagnosis of dementia or other severe cognitive impairment (MMSE\<24)
* History of stroke, traumatic brain injury or other neurological disorders (other than PD and MCI, for those groups)
* Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and orthopaedic diseases
* Unstable medical condition in the past 6 months
* Unable to comply with the training
* Interfering therapy
D: Inclusion Criteria:

1. Diagnosed with idiopathic PD.
2. At least 30 years old at the time of PD diagnosis.
3. Currently being treated with IR LD (CD-LD or benserazide-LD) and on a stable regimen of IR LD for at least 4 weeks and:

   * Requiring a total daily IR LD dose of at least 400 mg
   * Having a minimum dosing frequency of four times per day.
4. Able to differentiate "on" state from "off" state.
5. Have predictable "off" periods.
6. Amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are allowed as long as the doses and regimens have been stable for at least 4 weeks prior to Screening and the therapy is intended to be constant throughout the course of the study.
7. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.

Exclusion Criteria:

1. Diagnosed with atypical Parkinsonism or any known secondary Parkinsonian syndrome.
2. Nonresponsive to LD therapy.
3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
4. Received within 4 weeks or planning to take during participation in the clinical study: any controlled-release LD product, additional CD (e.g., Lodosyn®) or benserazide (e.g. Serazide®), catechol-O-methyl transferase inhibitors (e.g., entacapone and tolcapone), nonselective MAO inhibitors, apomorphine, and antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
5. Allergic to Yellow Dye #5 (tartrazine).
6. History of or currently active psychosis.
7. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
8. Active or history of narrow-angle glaucoma.
9. A history of malignant melanoma or a suspicious undiagnosed skin lesion.
10. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome and/or nontraumatic rhabdomyolysis.
11. Received any investigational medications during the 4 weeks prior to Screening.
12. Unable to swallow large pills (e.g., large vitamin pills).
13. Pregnant or breastfeeding.
14. Subjects who are unable to complete a symptom diary.

Answer: C