Gait Disorders in Parkinson's Disease

NCT03416452 | Withdrawn Early Phase 1

• 2 other identifiers: 18005018-N-0050
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Parkinson's Disease

Keywords

Gait; Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  ongoing

• Changes in Stride length

  ongoing

Study Arms (5)

PD patients no

EXPERIMENTAL

PD patients without freezing of gait

Device: Mobile Gait Trainer

Healthy

PLACEBO COMPARATOR

HV using Mobile Gait Trainer

Device: Mobile Gait Trainer

PD patients

EXPERIMENTAL

pd patients using vibratory cueing device

Device: vibratory cueing device

PD patients 1

EXPERIMENTAL

PD patients with freezing of gait

Device: vibratory cueing device

Healthy Volunteers

EXPERIMENTAL

Age and gender matched healthy volunteers.

Device: Mobile Gait Trainer

Interventions

vibratory cueing device DEVICE

ankle brace with vibrator that provides electric stimulus

PD patients; PD patients 1

Mobile Gait Trainer DEVICE

standard rolling walker that has a battery operated sensor attached to the side, designed to detect footsteps

Healthy; Healthy Volunteers; PD patients no

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Related Publications (1)

• 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.

  PMID: 23326758 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Shabbir Hussain I Merchant, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: January 31, 2018
• Study Start: January 24, 2018
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11