Freezing of Gait in Parkinson's Disease

NCT01887054 | Completed FDA Device

• 1 other identifier: Pro00045495
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Double Limb Support (DLS)

  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.

  6 weeks

Study Arms (2)

Training Group

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

Device: Tower of Hanoi

Non Training Group

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

Other: Placebo group - non use of Tower of Hanoi

Interventions

Tower of Hanoi DEVICE

Training Group

Placebo group - non use of Tower of Hanoi OTHER

Non Training Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Mark Stacy, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 26, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

US (1)