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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236286
• Other study ID #: 8979
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
United States	VA Portland Health Care System (VAPORHCS)	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Secondary	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.	Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Secondary	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.	Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Secondary	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.	Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Secondary	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.	Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Secondary	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.	Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Secondary	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.	Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Secondary	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.	Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Secondary	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.	Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)