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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise

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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Agility Boot Camp (ABC) exercise intervention consisting of 18 sessions of group exercise led by an exercise trainer.

Chronic Disease Management Education

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.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

Agility Boot Camp (ABC) exercise intervention consisting of 18 sessions of group exercise led by an exercise trainer.

Interventions

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Exercise

Agility Boot Camp (ABC) exercise intervention consisting of 18 sessions of group exercise led by an exercise trainer.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes