Please select the eligibility criteria that correspond to the clinical trial below.
Title: Physical Therapy and Deep Brain Stimulation in Parkinson Disease
Brief Summary: While deep brain stimulation of the subthalamic nucleus (STN-DBS) is commonly used to reduce tremor, muscle stiffness, and bradykinesia in people with Parkinson disease (PD), preliminary studies suggest balance may worsen and falls may increase after STN-DBS. Walking speed, known to be reduced in PD, typically improves after surgery; however, other important gait qualities may not improve. Given the potential for worsening balance and gait and increasing falls after surgery, it is imperative that researchers explore interventions that complement the positive effects of STN-DBS and delay worsening of balance and gait.

Physical therapy (PT) is reported to be effective in improving balance and walking in people with PD. However, there have been no studies to investigate how individuals with STN-DBS respond to PT. As such, it is unclear if exercise in the post-DBS population is safe, feasible, and effective. The purpose of this study is to examine the safety, feasibility, and efficacy of PT in people with PD with STN-DBS.

The investigators hypothesize that PT will be safe and feasible for people with PD with STN-DBS. Further, the investigators hypothesize that those assigned to PT group will demonstrate improvements in balance and gait while those assigned to the control group will demonstrate no change or a decline in balance and gait.


Options:
A: Inclusion Criteria:

* Person is 18 to 80 years of age
* Person has been diagnosed with Parkinson's disease for at lease five (5) years
* Person experiences at least six (6) hours or more daily "off-time" or moderate to severe dyskinesias during waking hours
* Person has a history of improvement of Parkinson's symptoms with l-dopa (levodopa) therapy
* Person must be willing to maintain a constant dose of anti-Parkinson's disease medication for at least one month prior to study enrollment
* Person must be available for appropriate follow-up times for the length of the study

Exclusion Criteria:

* Person has any major illness or medical condition that would interfere with participation in the study
* Person currently suffers from untreated, major depression
* Person has an electrical or electromagnetic implant (e.g. cochlear prosthesis or pacemaker)
* Person has had a prior surgery for the treatment of PD symptoms, including previous DBS surgery
* Person has dementia
* Person has a history of seizures
B: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson disease
* Hoehn \& Yahr stages II-IV
* At least 1 year post-STN-DBS
* Able to provide informed consent

Exclusion Criteria:

* Diagnosis of atypical parkinsonism
* Hoehn \& Yahr stages I or V
* Evidence of dementia (MMSE \< 24/30)
* Inability to walk 10 meters with or without assistive device
C: 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
D: Inclusion Criteria:

* The study population will consist of male or female outpatients at least 50 years of age with mild to moderate disease severity (MMSE 12 to 24 inclusive) according to UKPDS and DSM IV TR criteria (for PDD patients) and the third report of the DLB consortium (for DLB patients) and who have a knowledgeable and reliable caregiver to accompany the patient to all clinic visits during the course of the study.

Exclusion Criteria:

* Evidence of clinically significant active disease, evidence of other neurological disorders, and current treatment with AChEIs.

Answer: B