VA Portland Health Care System (VAPORHCS)
Portland, Oregon, 97239, United States
NCT Number: NCT02236286
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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Notify Me50 year–90 year
All sexes
Interventional
Not applicable
Portland, Oregon, 97239, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Control subjects:
Agility Boot Camp (ABC) exercise intervention consisting of 18 sessions of group exercise led by an exercise trainer.
Time frame: Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
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)
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)
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)
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)
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)
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)
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)
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)
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.
Oregon Health and Science University
Other
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