Clinical trial NCT00320242: Laser Light Cues for Gait Freezing in Parkinson's Disease
Official title: An Open Label Study to Assess the Efficacy of Visual Cues in the Form of the Laser Cane or the U-Step Walker With Laser Accessory in Parkinson's Disease Patients Who Experience Freezing of Gait.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
laser cane
freezing of gait
visual cues
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2006-05-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to gather data to see if the Laser Cane and/or U-Step Walker with laser accessory is more effective in aiding with gait freezing than a regular cane/U-Step Walker in patients who have idiopathic Parkinson's disease.

Detailed description: Freezing of gait is a significant clinical problem in Parkinson's disease (PD). It interferes with daily functioning and quality of life and often results in falls that potentially can inflict serious injury. In recent years, much more attention has been focused on the clinical characteristics of gait freezing, the severity of falls that can result, and the use of visual cues as a possible treatment in order to understand the implications of episodic freezing. Few clinical studies have been done to confirm the clinical observations to date. The laser cane is a device that has been used and prescribed in movement disorder centers as the only form of treatment for freezing of gait. Although it has been shown to be effective in many cases, there is no published data to support what has been observed in the clinic. The proposed study seeks to clarify unanswered questions regarding the laser cane and its efficacy in aiding with episodic gait freezing and falls.

Eligibility criteria: Inclusion Criteria:

* Subjects or a designated proxy have given informed consent
* Subject has been diagnosed with idiopathic Parkinson's disease
* Subject is ambulatory. If a wheelchair is used part-time, it must be used for less than 50% of the time
* Positive assessment for Questionnaire Used to Identify Freezing of Gait in PD Patients at subject's best "on"

Exclusion Criteria:

* Presence of atypical features suggestive of MSA, PSP, ataxia, unexplained or prominent pyramidal signs, and/or autonomic dysfunction
* Subjects who are non-ambulatory more than 50% of the time
* Subjects who have had a history of syncope in the 6 months prior to screening
* Subjects with moderate or advanced dementia

Primary outcomes:
measure: Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score.
timeFrame: 2-3 months
Secondary outcomes:
measure: Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature
timeFrame: 2-3 months
measure: Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue.
timeFrame: 2-3 months
measure: Percentage Change in Falls
timeFrame: 1 to 2 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: The Neurological Institute of New York at Columbia University
state: New York
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: David K Simon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Donovan S, Lim C, Diaz N, Browner N, Rose P, Sudarsky LR, Tarsy D, Fahn S, Simon DK. Laserlight cues for gait freezing in Parkinson's disease: an open-label study. Parkinsonism Relat Disord. 2011 May;17(4):240-5. doi: 10.1016/j.parkreldis.2010.08.010. Epub 2010 Sep 3.