Gait Disorders in Parkinson's Disease

November 19, 2018 updated by: National Institute of Neurological Disorders and Stroke (NINDS)

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

Study Overview

Status

Status

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Withdrawn

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.

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:

  1. Sub Study 1: Physiology of Freezing of Gait in Parkinson Disease (abbrev: Physiology of FOG)

    1. 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.
    2. Study Population: 15 PD patients with freezing of gait, 15 patients without freezing of gait, 15 age and gender matched healthy volunteers
    3. Design: Prospective Exploratory study
    4. 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.

  2. Sub Study 2: Effects of Rhythmic Vibratory Cueing to Improve Step Parameters in Parkinson Disease (abbrev. Vibratory Cueing)

    1. 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.
    2. Study population: 15 patients diagnosed as having Parkinson s Disease, Hoehn and Yahr stage 2-3.
    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).

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

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.
  • Early Phase 1

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

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: Supportive Care
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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: PD patients no
PD patients without freezing of gait
Device: Mobile Gait Trainer
standard rolling walker that has a battery operated sensor attached to the side, designed to detect footsteps
Placebo Comparator: Healthy
HV using Mobile Gait Trainer
Device: Mobile Gait Trainer
standard rolling walker that has a battery operated sensor attached to the side, designed to detect footsteps
Experimental: PD patients
pd patients using vibratory cueing device
Device: vibratory cueing device
ankle brace with vibrator that provides electric stimulus
Experimental: PD patients 1
PD patients with freezing of gait
Device: vibratory cueing device
ankle brace with vibrator that provides electric stimulus
Experimental: Healthy Volunteers
Age and gender matched healthy volunteers.
Device: Mobile Gait Trainer
standard rolling walker that has a battery operated sensor attached to the side, designed to detect footsteps

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
Time Frame
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
ongoing
Changes in Stride length
Time Frame: ongoing
ongoing

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.
National Institute of Neurological Disorders and Stroke (NINDS)

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: Shabbir Hussain I Merchant, M.D., National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
January 24, 2018

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.
November 13, 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.
November 13, 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).
January 30, 2018

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.
January 30, 2018

First Posted (Actual)

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.
January 31, 2018

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.
November 20, 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.
November 19, 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.
November 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.
  • 180050
  • 18-N-0050

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Parkinson's Disease

Clinical Trials on Mobile Gait Trainer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings