Freezing of Gait in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: Placebo group - non use of Tower of Hanoi; Device: Tower of Hanoi

• Registration Number: NCT01887054
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-26
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non Training Group	Placebo group - non use of Tower of Hanoi	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
Training Group	Tower of Hanoi	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

Primary Outcome Measures

Name	Time	Method
Double Limb Support (DLS)	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States