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Withdrawn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
About this trial
This is an interventional supportive care trial for Parkinson's Disease focused on measuring Gait, Parkinson's Disease
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.
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
NCT ID
NCT03416452
First Posted
January 30, 2018
Last Updated
November 19, 2018
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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
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Gait Disorders in Parkinson's Disease
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