Overview

This trial is active, not recruiting.

Condition parkinson disease
Treatments tower of hanoi, placebo group - non use of tower of hanoi
Sponsor Duke University
Start date June 2013
End date March 2017
Trial size 60 participants
Trial identifier NCT01887054, Pro00045495

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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
tower of hanoi
(Placebo Comparator)
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
placebo group - non use of tower of hanoi

Primary Outcomes

Measure
Double Limb Support (DLS)
time frame: 6 weeks

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Duke University.