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Freezing of Gait in Parkinson's Disease (FOG)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tower of Hanoi
Placebo group - non use of Tower of Hanoi
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Training Group

Non Training Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Double Limb Support (DLS)
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.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2013
Last Updated
January 23, 2017
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT01887054
Brief Title
Freezing of Gait in Parkinson's Disease
Acronym
FOG
Official Title
Effect of Visuospatial Training Tasks on Freezing of Gait in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Non Training Group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Tower of Hanoi
Intervention Type
Other
Intervention Name(s)
Placebo group - non use of Tower of Hanoi
Primary Outcome Measure Information:
Title
Double Limb Support (DLS)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Stacy, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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Freezing of Gait in Parkinson's Disease

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