Frontal Cortex and Gait Freezing in Parkinson's Disease: Rehabilitation Impact

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Parkinson's Disease

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02236286

8979

Details and patient eligibility

About

This project will relate our new quantification of Freezing of Gait (FoG) in Parkinson's disease, using body worn inertial sensors (Aim I), with abnormalities in state-of-the-art, resting state, functional brain connectivity (Aim II), and determine the number of subjects needed for a future, randomized clinical trial to test the efficacy of our novel, Agility Boot Camp (ABC) rehabilitation intervention for FoG (Aim III). The technological approaches to these aims are cutting edge and will allow us to develop sensitive behavioral and brain biomarkers for gait disorders in Parkinson's disease (PD) for use in future clinical trials.

Enrollment: 16 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 50-90 years old.
• No musculoskeletal or peripheral or central nervous system disorders (other than idiopathic Parkinson disease, iPD) that could significantly affect balance or gait .
• Capable of following directions.
• iPD subjects: United Kingdom Brain Bank criteria, i.e., bradykinesia and at least one of the following: rest tremor, muscular rigidity, and postural instability not cause by visual, vestibular, cerebellar or proprioceptive dysfunction. Unilateral onset, response to levodopa.

Exclusion criteria

• Inability to stand or walk for 2 min without an assistive device
• Recent changes in medication
• Excessive use of alcohol or recreational drugs,
• Contraindications to MRI scans (eg, claustrophobia, metal in body)
• Intervention subjects will be excluded if: 1) participating in a vigorous exercise program more than 2 x/week, 2) A medical condition that contraindicates exercise participation.
• Idiopathic PD subjects: Same as above and deep brain stimulation electrodes. Significant tremor that would interfere with MRI scan.

Control subjects:

• Will be matched for age and gender to iPD group.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Exercise

Experimental group

Description:

Subjects will participate in a 90-minute, group (6 per group) exercise session 3 days per week for 6 weeks (18 sessions). The theoretical basis for our novel Agility Boot Camp (ABC) exercise program is based on research that identified the primary neurophysiological and cognitive constraints that limits balance and mobility in PD. The exercises are designed as a circuit with several types of movement-skills specifically focused on improving different postural domains with cognitive challenges such as memorized sequences and dual tasking.

Treatment:

Behavioral: Exercise

Chronic Disease Management Education

Active Comparator group

Description:

Subjects will also receive (cross-over) six weeks of educational classes. The Education program will teach subjects, chronic disease self-management - how to live better with their parkinsonism. Classes will consist of 6 subjects per group meeting for 90 minute sessions, once a week for six weeks. Subject will do an additional 120 minutes of relaxation at home/week.

Treatment:

Behavioral: Exercise