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Gait Disorders in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
vibratory cueing device
Mobile Gait Trainer
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson's Disease focused on measuring Gait, Parkinson's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers
  • INCLUSION CRITERIA:
  • Age 18 years or older
  • Able to provide informed consent
  • Clinical diagnosis of Parkinson disease by U.K. Parkinson Society Brain Bank Criteria
  • Patients must be stage II -III on the Hoehn and Yahr scale

EXCLUSION CRITERIA:

  • MoCA<25 within the last 6 months
  • Uncontrolled medical condition requiring immediate treatment that would make a walking trial unsafe for the subject.
  • Peripheral neuropathy that severely limits gait
  • Current or recent orthopedic disorder that severely limits gait
  • Current uncontrolled depression or major depressive episode
  • Gait disorders other than PD.
  • Cannot walk safely without corrective lenses and without support.
  • Unable to abstain from PD medications overnight for at least 12 hours before testing
  • History of deep brain stimulation surgery
  • Subjects who are NINDS employees
  • In addition to the preceding criteria, healthy volunteers must also have a normal neurological examination performed within the last year. Healthy volunteers will be healthy subjects without any major medical and neurological or psychiatric disorders established by history and physical/neurological examination. They will also have no gait disorders from any medical or surgical problems as per clinical assessment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    PD patients no

    Healthy

    PD patients

    PD patients 1

    Healthy Volunteers

    Arm Description

    PD patients without freezing of gait

    HV using Mobile Gait Trainer

    pd patients using vibratory cueing device

    PD patients with freezing of gait

    Age and gender matched healthy volunteers.

    Outcomes

    Primary Outcome Measures

    To examine the relative phase variability or coherence between oscillating axial and appendicular components of gait in PD + FOG, compared to PD-FOG and healthy controls.
    Changes in Stride length

    Secondary Outcome Measures

    Full Information

    First Posted
    January 30, 2018
    Last Updated
    November 19, 2018
    Sponsor
    National Institute of Neurological Disorders and Stroke (NINDS)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03416452
    Brief Title
    Gait Disorders in Parkinson's Disease
    Official Title
    Gait Disorders in Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Investigator left the NIH.
    Study Start Date
    January 24, 2018 (Actual)
    Primary Completion Date
    November 13, 2018 (Actual)
    Study Completion Date
    November 13, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Institute of Neurological Disorders and Stroke (NINDS)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Background: Parkinson s disease (PD) is a neurologic disorder that causes slowness, tremor, rigidity, and imbalance. Gait impairment is also common. There are 2 substudies: (1) Physiology of Freezing and Gait; (2) Vibratory Cueing. Healthy participants can join only Substudy 1. Objective: To study gait disorders in PD. Also, to test the effect of specific interventions for gait in people with PD. Eligibility: People ages 18 and older who: Have PD with bilateral symptoms but can walk without a cane or walker Are healthy Design: Participants will be screened in Protocols 93-N-0202 and 01-N-0206. Both substudies include a physical exam and medical history. Substudy 1: Participants will have one 6-hour visit. They must wear a tank tops and shorts with tennis shoes during the visit. They will perform gait tasks. Markers placed on the skin will record movements. They will have an EEG: They will wear an electrode cap to record brain waves. They will wear special glasses to record eye movements. Participants with PD will hold their morning dose of PD drugs. They can choose to be admitted to the hospital the previous evening. Otherwise someone else or a taxi must bring them to the visit. They will first perform the study tasks off their drugs. Then they will take their drugs and repeat them. Substudy 2: Participants will have one 3-hour visit. A small vibratory device will be attached to their ankle. Reflective markers placed on the skin will record movements while they walk: Without the device With the device, but the vibrator off With the device, with the vibrator on With a magnet attached to the ankle
    Detailed Description
    The objective of this protocol is to study the physiology of gait disorders in Parkinson s disease as well as to test the effect of non-invasive interventions on gait function in patients with Parkinson s disease. To this end, this protocol will consist of two sub studies: Sub Study 1: Physiology of Freezing of Gait in Parkinson Disease (abbrev: Physiology of FOG) Objective: To explore temporospatial gait parameters and joint kinematic patterns in patients with Parkinson disease and freezing of gait. In addition, tracking of eye movements and EEG patterns will also be studied in patients with Parkinson disease and freezing of gait. Study Population: 15 PD patients with freezing of gait, 15 patients without freezing of gait, 15 age and gender matched healthy volunteers Design: Prospective Exploratory study Outcome Measures: Phase variability and coherence of oscillating axial and appendicular components of gait in patients with PD and freezing of gait, visual gaze fixations and saccades during freezing or freezing-like events and when approaching a variable width doorway, EEG patterns during an episode of freezing of gait or freeze-like event. The study will also aim to look at the difference in the phenomenon of FOG in OFF and ON states. Sub Study 2: Effects of Rhythmic Vibratory Cueing to Improve Step Parameters in Parkinson Disease (abbrev. Vibratory Cueing) Objective: To study changes in gait variables of patients with PD by providing rhythmic vibratory stimuli at the ankle on one limb at preset parameters. Study population: 15 patients diagnosed as having Parkinson s Disease, Hoehn and Yahr stage 2-3. Design: Prospective interventional hypothesis testing study. We will evaluate the effects of rhythmic vibratory cueing on gait variables in PD. The effects of vibratory cueing will be tested compared to baseline gait variables and with the use of a magnet (which will be the open label placebo intervention to account to some extent, for the open label design).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease
    Keywords
    Gait, Parkinson's Disease

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PD patients no
    Arm Type
    Experimental
    Arm Description
    PD patients without freezing of gait
    Arm Title
    Healthy
    Arm Type
    Placebo Comparator
    Arm Description
    HV using Mobile Gait Trainer
    Arm Title
    PD patients
    Arm Type
    Experimental
    Arm Description
    pd patients using vibratory cueing device
    Arm Title
    PD patients 1
    Arm Type
    Experimental
    Arm Description
    PD patients with freezing of gait
    Arm Title
    Healthy Volunteers
    Arm Type
    Experimental
    Arm Description
    Age and gender matched healthy volunteers.
    Intervention Type
    Device
    Intervention Name(s)
    vibratory cueing device
    Intervention Description
    ankle brace with vibrator that provides electric stimulus
    Intervention Type
    Device
    Intervention Name(s)
    Mobile Gait Trainer
    Intervention Description
    standard rolling walker that has a battery operated sensor attached to the side, designed to detect footsteps
    Primary Outcome Measure Information:
    Title
    To examine the relative phase variability or coherence between oscillating axial and appendicular components of gait in PD + FOG, compared to PD-FOG and healthy controls.
    Time Frame
    ongoing
    Title
    Changes in Stride length
    Time Frame
    ongoing

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    INCLUSION CRITERIA: Age 18 years or older Able to provide informed consent Clinical diagnosis of Parkinson disease by U.K. Parkinson Society Brain Bank Criteria Patients must be stage II -III on the Hoehn and Yahr scale EXCLUSION CRITERIA: MoCA<25 within the last 6 months Uncontrolled medical condition requiring immediate treatment that would make a walking trial unsafe for the subject. Peripheral neuropathy that severely limits gait Current or recent orthopedic disorder that severely limits gait Current uncontrolled depression or major depressive episode Gait disorders other than PD. Cannot walk safely without corrective lenses and without support. Unable to abstain from PD medications overnight for at least 12 hours before testing History of deep brain stimulation surgery Subjects who are NINDS employees In addition to the preceding criteria, healthy volunteers must also have a normal neurological examination performed within the last year. Healthy volunteers will be healthy subjects without any major medical and neurological or psychiatric disorders established by history and physical/neurological examination. They will also have no gait disorders from any medical or surgical problems as per clinical assessment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shabbir Hussain I Merchant, M.D.
    Organizational Affiliation
    National Institute of Neurological Disorders and Stroke (NINDS)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23326758
    Citation
    Kelly VE, Eusterbrock AJ, Shumway-Cook A. The effects of instructions on dual-task walking and cognitive task performance in people with Parkinson's disease. Parkinsons Dis. 2012;2012:671261. doi: 10.1155/2012/671261. Epub 2012 Dec 29.
    Results Reference
    background

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    Gait Disorders in Parkinson's Disease

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