Freezing of Gait in Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Tower of Hanoi
* Other: Placebo group - non use of Tower of Hanoi


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Training Group<br>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<br> <br> |
| Placebo Comparator: Non Training Group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks |