Freezing of Gait in Parkinson's Disease (FOG)

Duke University

Status: Completed

Conditions: Parkinson Disease

Treatments: Other: Placebo group - non use of Tower of Hanoi; Device: Tower of Hanoi

Study type: Interventional

Funder types: Other

Identifiers

NCT01887054

Pro00045495

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups, including a placebo group

Training Group

Active Comparator group

Description:

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

Treatment:

Device: Tower of Hanoi

Non Training Group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo group - non use of Tower of Hanoi