Freezing of Gait in Parkinson's Disease

NCT ID: NCT01887054

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-08-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Training Group

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

Group Type: ACTIVE_COMPARATOR

Tower of Hanoi

Intervention Type: DEVICE

Non Training Group

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

Group Type: PLACEBO_COMPARATOR

Placebo group - non use of Tower of Hanoi

Intervention Type: OTHER

Interventions

Tower of Hanoi

Intervention Type: DEVICE

Placebo group - non use of Tower of Hanoi

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Stacy, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00045495

Identifier Type: -

Identifier Source: org_study_id