Back to resultsFrontal Cortex and Gait Freezing in Parkinson's Disease: Rehabilitation Impact
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional other trial for Parkinson's Disease focused on measuring freezing of gait (FOG), balance, gait, exercise
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.
Sites / Locations
- VA Portland Health Care System (VAPORHCS)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise
Chronic Disease Management Education
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change in Freezing of Gait Index
Quantify amount of freezing in the legs ('trembling of knees'), defined as the square of the total power in the 3-8 Hz band, divided by the square of the total power in the 0.5-3 Hz band.
Secondary Outcome Measures
Change in the New Freezing of Gait Questionnaire (NFOGQ) score
The NFOGQ will be used to identify 'freezers' (score > 3). It is a self-report measure that begins with the presentation of a short video to illustrate FoG during walking, turning and starting gait and then follows with questions related to frequency and duration of each type of FoG episode.
Change in PDQ-39 score
The Parkinson's Disease Quality of Life Questionnaire (PDQ-39) has 39 questions reflecting eight domains of quality of life (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort). Each item scores from 0 (never) to 4 (always). Subscale scores and a summary index representing the global health-related quality of life will be calculated, with higher scores representing worse quality of life. Convergent validity is very good and discriminative validity for PD severity levels have been established. The PDQ-39 will reflect limitations to participation in community mobility.
Change in Activities of Balance Confidence (ABC) Questionnaire score
ABC questionnaire consists of 16 questions about how balance confidence limits participating in the community such as riding an escalator or walking in a crowded area, Subjects indicate their confidence from 0 - 100% in being able to complete each of the tasks. A score of 80% indicates an average level of physical functioning for older adults.
Change in instrumented gait and balance measures
Gait: Walking metrics will be collected during short (7 meter, 180° turn, 7 meter) and long (2 minutes) walks.
Instrumented Brief BESTest - another variation of the BESTest (Balance Evaluation - Systems Test) that will be administered with inertial sensors to quantify the important metrics of the test.
Change in mini-BESTest score
The mini-BESTest assesses dynamic balance via a 14-item test that measure multiple domains of balance including anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.
Change in UPDRS score
The Unified Parkinson's Disease Rating Scale (UPDRS) Motor Subscale is a 10-minute assessment of motor signs related to severity of PD. If the investigators have trouble recruiting subjects of similar severity in the 2 groups (PD Freezers and Non-Freezers, then they will use the Postural Instability and Gait Disability (PIGD) Subscore as a covariate in data analysis.
Change in locomotor neural network functional connectivity strength
Changes in resting state blood oxygen level dependent neural signal synchronization between Supplementary Motor Area and Mesencephalic locomotor region across 3 time points.
Change in SCOPA-COG score
Scales for Outcomes in Parkinson's Disease-cognition (SCOPA-COG) is an instrument that was designed to assess the specific 'frontal-subcortical' cognitive deficits found in Parkinson's disease. The scale, consisting of 10 items, covers the following domains: memory and recall (verbal recall, digit span backward, and indicate cubes), attention (counting backward, months backward), executive function (fist-edge-palm, semantic fluency, and dice), visual-spatial functions (assembly pattern), and memory (delayed recall). The score ranges from 0-43 points with higher scores reflecting better performance.
Full Information
NCT ID
NCT02236286
First Posted
September 3, 2014
Last Updated
October 29, 2018
Sponsor
Oregon Health and Science University
Collaborators
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT02236286
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
freezing of gait (FOG), balance, gait, exercise
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm 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.
Arm Title
Chronic Disease Management Education
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Agility Boot Camp (ABC) exercise intervention consisting of 18 sessions of group exercise led by an exercise trainer.
Primary Outcome Measure Information:
Title
Change in Freezing of Gait Index
Description
Quantify amount of freezing in the legs ('trembling of knees'), defined as the square of the total power in the 3-8 Hz band, divided by the square of the total power in the 0.5-3 Hz band.
Time Frame
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Secondary Outcome Measure Information:
Title
Change in the New Freezing of Gait Questionnaire (NFOGQ) score
Description
The NFOGQ will be used to identify 'freezers' (score > 3). It is a self-report measure that begins with the presentation of a short video to illustrate FoG during walking, turning and starting gait and then follows with questions related to frequency and duration of each type of FoG episode.
Time Frame
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Title
Change in PDQ-39 score
Description
The Parkinson's Disease Quality of Life Questionnaire (PDQ-39) has 39 questions reflecting eight domains of quality of life (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social Support, Cognition, Communication, and Bodily Discomfort). Each item scores from 0 (never) to 4 (always). Subscale scores and a summary index representing the global health-related quality of life will be calculated, with higher scores representing worse quality of life. Convergent validity is very good and discriminative validity for PD severity levels have been established. The PDQ-39 will reflect limitations to participation in community mobility.
Time Frame
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Title
Change in Activities of Balance Confidence (ABC) Questionnaire score
Description
ABC questionnaire consists of 16 questions about how balance confidence limits participating in the community such as riding an escalator or walking in a crowded area, Subjects indicate their confidence from 0 - 100% in being able to complete each of the tasks. A score of 80% indicates an average level of physical functioning for older adults.
Time Frame
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Title
Change in instrumented gait and balance measures
Description
Gait: Walking metrics will be collected during short (7 meter, 180° turn, 7 meter) and long (2 minutes) walks.
Instrumented Brief BESTest - another variation of the BESTest (Balance Evaluation - Systems Test) that will be administered with inertial sensors to quantify the important metrics of the test.
Time Frame
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Title
Change in mini-BESTest score
Description
The mini-BESTest assesses dynamic balance via a 14-item test that measure multiple domains of balance including anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.
Time Frame
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Title
Change in UPDRS score
Description
The Unified Parkinson's Disease Rating Scale (UPDRS) Motor Subscale is a 10-minute assessment of motor signs related to severity of PD. If the investigators have trouble recruiting subjects of similar severity in the 2 groups (PD Freezers and Non-Freezers, then they will use the Postural Instability and Gait Disability (PIGD) Subscore as a covariate in data analysis.
Time Frame
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Title
Change in locomotor neural network functional connectivity strength
Description
Changes in resting state blood oxygen level dependent neural signal synchronization between Supplementary Motor Area and Mesencephalic locomotor region across 3 time points.
Time Frame
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Title
Change in SCOPA-COG score
Description
Scales for Outcomes in Parkinson's Disease-cognition (SCOPA-COG) is an instrument that was designed to assess the specific 'frontal-subcortical' cognitive deficits found in Parkinson's disease. The scale, consisting of 10 items, covers the following domains: memory and recall (verbal recall, digit span backward, and indicate cubes), attention (counting backward, months backward), executive function (fist-edge-palm, semantic fluency, and dice), visual-spatial functions (assembly pattern), and memory (delayed recall). The score ranges from 0-43 points with higher scores reflecting better performance.
Time Frame
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fay B Horak, PhD, PT
Organizational Affiliation
VA Portland Health Care System (VAPORHCS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System (VAPORHCS)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Frontal Cortex and Gait Freezing in Parkinson's Disease: Rehabilitation Impact
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