Freezing of Gait in Parkinson's Disease
This trial is active, not recruiting.
|Treatments||tower of hanoi, placebo group - non use of tower of hanoi|
|Start date||June 2013|
|End date||March 2017|
|Trial size||60 participants|
|Trial identifier||NCT01887054, Pro00045495|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Double Limb Support (DLS)
time frame: 6 weeks
Male or female participants at least 18 years old.
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.
|Official title||Effect of Visuospatial Training Tasks on Freezing of Gait in Parkinson's Disease|
|Principal investigator||Mark Stacy, MD|
|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.|
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