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

October 29, 2018 updated by: Fay B. Horak, Oregon Health and Science University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System (VAPORHCS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Exercise
Agility Boot Camp (ABC) exercise intervention consisting of 18 sessions of group exercise led by an exercise trainer.
Active Comparator: 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.
Behavioral: Exercise
Agility Boot Camp (ABC) exercise intervention consisting of 18 sessions of group exercise led by an exercise trainer.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Freezing of Gait Index
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.
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the New Freezing of Gait Questionnaire (NFOGQ) score
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.
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in PDQ-39 score
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.
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in Activities of Balance Confidence (ABC) Questionnaire score
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.
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in instrumented gait and balance measures
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.
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in mini-BESTest score
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.
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in UPDRS score
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.
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in locomotor neural network functional connectivity strength
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.
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)
Change in SCOPA-COG score
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.
Three timepoints; baseline, 6 weeks (after Arm 1), 12 weeks (after Arm 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
US Department of Veterans Affairs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fay B Horak, PhD, PT, VA Portland Health Care System (VAPORHCS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8979

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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