Using Gait Robotics to Improve Symptoms of Parkinson's Disease
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
This study evaluates the benefits of exoskeleton-based exercise for improving mood and
 cognition in people with Parkinson's disease (PD). Participants with PD will be assigned one
 of three treatments delivered over 8-weeks: exoskeleton exercise (experimental intervention),
 non-exoskeleton exercise (active comparator), and wait-list control (no treatment).
Parkinson's Disease (PD) is a movement disorder that significantly impairs mobility and
 increases risk of falls. Many people with PD also experience mild cognitive impairment (MCI)
 and some progress to Parkinson's disease dementia (PDD). Non-pharmacologic treatments such as
 physical activity and exercise are known to be neuroprotective and may improve cognition,
 mood and overall functioning in PD, but such interventions can be challenging for individuals
 with PD and cognitive impairment to fully participate in. Robotic over-ground exoskeletons
 have the potential to overcome this barrier; however there are no scientific data yet to
 support the use robotic exoskeletons in the PD population or those with mood disorder and/or
 declining cognitive function.

 This therapeutic exploratory trial will fill this gap in knowledge and provide critical data
 for understanding how to integrate exoskeletons into clinical practice for age-related
 movement disorders when cognitive decline is present. Specifically we will test if an 8-week
 functional exercise program (gait, balance, aerobic exercise) using the KEEOGO Rehab(tm)
 exoskeleton can improve mood and cognition, as well as gait and balance, compared to the same
 functional exercise without using the exoskeleton, and a wait-list control (no treatment).
Inclusion Criteria:

 -  Provision of signed and dated informed consent form

 -  Stated willingness to comply with all study procedures and availability for the
 duration of the study

 -  Cognitive function score >=16 on Montreal Cognitive Assessment (MoCA)

 -  Diagnosed with Parkinson's disease, Hoehn and Yahr stage 1 to 4

 -  Able to walk 10 meters without stopping and without human assistance (using assistive
 devices such as cane or walker if normally used)

 -  Waist and leg circumference and lower extremity lengths appropriate for a comfortable
 and safe fit in the KEEOGO device

 Exclusion Criteria:

 -  Legally blind

 -  Treatment with another investigational drug or other intervention within the study
 period

 -  New medications started within last 4 weeks

 -  Skin condition that contraindicates use of orthotics or support braces

 -  Lower-extremity amputation above or below the knee

 -  Uncontrolled orthostatic hypotension

 -  Psychiatric disorders such as schizophrenia or bipolar disorder

 -  Other diagnosis that impairs gait and balance, such as, but not limited to, chronic
 obstructive pulmonary disease; peripheral arterial disease; vestibular disorders;
 cerebellar disease; cerebral palsy; muscular dystrophy; spinal cord injury; stroke or
 other brain injury; severe degenerative joint disease (osteoarthritis, rheumatoid
 arthritis, etc.)