Freezing of Gait in Parkinson's Disease (FOG)

January 23, 2017 updated by: Duke University

Effect of Visuospatial Training Tasks on Freezing of Gait in Parkinson's Disease

This study is designed to evaluate whether a specific visuospatial training task will change gait performance of Parkinson's disease (PD) patients in doorways, specifically freezing of gait.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, prospective, single-blinded six-week study in PD patients with freezing of gait (FOG).

This study will involve 2 study groups:

Group A - training group; Group B - no training group/controls.

Both groups will complete a gait evaluation and neuropsychological testing. Group A will also practice an in-home visuospatial task for 30 minutes, 4-6 days per week for six weeks. Group B will not complete the in-home tasks.

Participation in this study is expected to last 6-8 weeks.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • 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
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

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

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: greater than 18 years old and without an upper age limit
  • diagnosis of idiopathic PD exhibiting at least 2 or 3 cardinal signs (bradykinesia, rigidity, and resting tremor)
  • Ambulate independently without an assistive device for at least 60 meters
  • Freezing of gait episodes confirmed through the FOG-Q and evaluation by a fellowship trained Movement Disorder neurologist
  • Willingness and ability to participate in training and complete training diary
  • Documented FOG-Q and Unified Parkinson's Disease Rating Scale (UPDRS) II
  • Ability to sign informed consent
  • Pregnant females will be included in the study and there are no known risks to the pregnant female or fetus

Exclusion Criteria:

  • Inability to complete questionnaires
  • Unwillingness to participate in training, complete all questionnaires and training diary
  • Subjects with secondary causes of parkinsonism
  • Significant dementia (MOCA <20)
  • Prior deep brain stimulation (DBS) surgery or pallidotomy
  • Subjects cannot participate in any form of Physical Therapy, Occupational Therapy or Speech Therapy during the study period
  • Subjects cannot start any new medications during the study period.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Training Group

There are 2 study visits. Subjects in this group will complete the following:

Visit 1

  • Gait evaluation
  • Neuropsychological testing
  • Questionnaires and assessments
  • Taught how to complete a visual problem-solving task (Tower of Hanoi)
  • Given a diary to record training at home.

In-home

•For 6 weeks at home, complete the in-home visual problem-solving tasks as instructed at Visit 1

Visit 2

  • Gait evaluation
  • Neuropsychological testing
  • Questionnaires and assessments
Device: Tower of Hanoi
Placebo Comparator: Non Training Group

There are 2 study visits. Subjects in this group will complete the following:

Visit 1

  • Gait evaluation
  • Neuropsychological testing
  • Questionnaires and assessments

Visit 2

  • Gait evaluation
  • Neuropsychological testing
  • Questionnaires and assessments
Other: Placebo group - non use of Tower of Hanoi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Double Limb Support (DLS)
Time Frame: 6 weeks
Primary outcome will be the percent of the gait cycle spent in DLS. This will be evaluated using a GaitRite via a continuous walk, with subjects walking an 18-20 meter oval loop three times continuously.
6 weeks

Collaborators and Investigators

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

Sponsor

Duke University

Investigators

  • Principal Investigator: Mark Stacy, MD, Duke University

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

June 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

June 25, 2013

First Posted (Estimate)

June 26, 2013

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00045495

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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