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Completed

NCT Number: NCT01887054

Freezing of Gait in Parkinson's Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tower of Hanoi

Device

Placebo group - non use of Tower of Hanoi

Other

Primary outcomes

  1. Double Limb Support (DLS)

    Time frame: 6 weeks

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Effect of Visuospatial Training Tasks on Freezing of Gait in Parkinson's Disease

Acronym: FOG

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2013
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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