Please select the eligibility criteria that correspond to the clinical trial below.
Title: Instrumental or Physical-exercise Rehabilitation of Balance Improve Both Balance and Gait in Parkinson's Disease.
Brief Summary: We hypothesized that rehabilitation specifically addressing balance in Parkinson ́s disease patients might improve not only balance, but locomotion as well. Two balance training protocols (standing on a moving platform, and traditional balance exercises) were compared by assigning patients to two groups: moving platform (n=15) and balance exercises (n=17). Platform moved periodically in antero-posterior, latero-lateral and oblique direction, with and without vision in different trials. Balance exercises were based on Otago Exercise Program. Both platform and exercises sessions were administered from easy to difficult. Outcome measures were: a) balancing behaviour, assessed both by index of stability (IS) on platform and by Mini-BESTest, b) gait, assessed both by baropodometry and by Timed Up and Go (TUG) test. Falls Efficacy Scale-International (FES-I) and Parkinson's Disease Questionnaire (PDQ-8) were administered. Both groups exhibited better balance control, as assessed both by IS and by Mini-BESTest. Gait speed at both baropodometry and TUG also improved in both groups. Scores of FES-I and PDQ-8 showed a marginal improvement. A four-week treatment featuring no gait training, but focussed on challenging balance tasks produces considerable gait enhancement in mildly to moderately affected patients. Walking problems in PD depend on postural instability and are successfully relieved by appropriate balance rehabilitation.


Options:
A: Inclusion Criteria:

* clinical diagnosis of probable idiopathic Parkinson's disease
* in stable health
* male and female aged 30-83 yrs
* Hoehn and Yahr stage II through IV inclusive
* levodopa-induced dyskinesias present greater than 25% of waking day; rating equal or greater than 2 on item 32 of UPDRS
* dyskinesias moderately or severely disabling as determined by a rating of equal or greater than 2 on item 33 of UPDRS
* Mini-Mental state (MMSE) score of equal or greater than 26
* on a stable dose of levodopa for at least 30 days
* if subjects are taking dopamine antagonists, amantadine, MAO-B inhibitors (rasagiline only) or COMT inhibitors, doses must have been stable for at least 30 days

Exclusion Criteria:

* Secondary or non-idiopathic Parkinson's disease
* Subjects with parkinsonian symptoms who do not respond to levodopa therapy
* history of schizophrenia, or other DSM-IV TR axis 1 diagnosis sufficient to interfere with or affect study conduct or interpretation of results
* any history (past 5 years) of suicide or suicide attempt or thoughts or urges of suicide on direct questioning
* subjects who score 2 or higher on a single module of the Jay MIDI scale
* moderate or severe hallucinations, psychoses or delusions
* any medical condition or lab abnormality presenting an unwarranted risk in the opinion of the Investigator
* history of HIV positivity, AIDS, or active hepatitis determined by subject report
* female who is pregnant or breastfeeding
* female of childbearing potential not using double barrier method of birth control throughout the duration of the study
* receipt of a neurosurgical intervention (e.g. brain surgery)related to Parkinson's disease or any neurosurgical procedure sufficient to interfere with study conduct or interpretation of results
* must not have systolic blood pressure ≥150; diastolic ≥95.
* must not have ECG at screening judged clinically significantly abnormal by investigator
* must not have QTc \> 450 msec at ECG screen
* must not have current angina pectoris, history of ventricular arrhythmias, uncontrolled hyperthyroidism, known or suspected pheochromocytoma, symptomatic vasospastic disease, or active peptic ulcer
* must not have a history of stroke, transient ischemic attack (TIA) or myocardial infarction within the last 2 years
* must not have current drug or alcohol abuse within the last two years. Acceptable alcohol use is no more than 3 ounces of alcohol, 3 beers or 2 glasses of wine per day.
* must not be participating in another drug trial or have participated in another drug study in the last 30 days. Observational trials with no intervention are acceptable provided permission is obtained from the other study sponsor in writing.
* must not be unwilling or unable to swallow capsules
* must not have a positive urine test for cotinine at screening
* must not be a smoker, previous (less than 5 years since cessation) smoker or have regular exposure to second hand smoke
* must not be allergic to capsule excipients
* must not be allergic to ondansetron. If allergic, they may participate provided they understand there is no rescue medication for potential nausea or vomiting during the study
* must not have known sensitivity to nicotine or nicotine-containing products
* must not be taking any of the following medications or substances within a minimum of 30 days: nicotine, any form; CYP2A6 inducers or inhibitors during the course of the study or within 30 days of the planned initial dose (your investigator will have a full list of these drugs); Monoamine oxidase inhibitors (with the exception of rasagiline, which is allowed)(your investigator will have a full list of these drugs); apokyn (apomorphine), due to its contraindication with ondansetron); warfarin.
B: Inclusion Criteria:

* Patients affected by PD;
* MMSE \> 21
* Hoehn and Yahr \<3

Exclusion Criteria:

* Presence of severe cognitive deficit
* Severe motor impairment (Hoehn and Yahr \>3)
* Medical illness potentially interfering with the training
C: Inclusion Criteria:

* patients with mild to moderate idiopathic Parkinson's disease (PD) (Hoehn-Yahr stage between 1.5 and 3)

Exclusion Criteria:

* orthopaedic conditions restricting exercise, or deep brain stimulation surgery or evidence of dementia . Patients not able walk independently.
D: 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

Answer: C