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Freezing of Gait in Parkinson's Disease (FOG)

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ClinicalTrials.gov Identifier: NCT01887054
Recruitment Status : Completed
First Posted : June 26, 2013
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Tower of Hanoi Other: Placebo group - non use of Tower of Hanoi Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Visuospatial Training Tasks on Freezing of Gait in Parkinson's Disease
Study Start Date : June 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887054


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Mark Stacy, MD Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01887054     History of Changes
Other Study ID Numbers: Pro00045495
First Posted: June 26, 2013    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases