Clinical trial NCT02236286: Frontal Cortex and Gait Freezing in Parkinson's Disease: Rehabilitation Impact
Official title: Frontal Cortex and Gait Freezing in Parkinson's Disease: Rehabilitation Impact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: freezing of gait (FOG)
balance
gait
exercise
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2014-09-10
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Freezing of Gait Index
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Secondary outcomes:
measure: Change in the New Freezing of Gait Questionnaire (NFOGQ) score
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
measure: Change in PDQ-39 score
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
measure: Change in Activities of Balance Confidence (ABC) Questionnaire score
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
measure: Change in instrumented gait and balance measures
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
measure: Change in mini-BESTest score
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
measure: Change in UPDRS score
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
measure: Change in locomotor neural network functional connectivity strength
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
measure: Change in SCOPA-COG score
timeFrame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System (VAPORHCS)
state: Oregon
Study officials:
affiliation: VA Portland Health Care System (VAPORHCS)
name: Fay B Horak, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: