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.

Laser Light Cues for Gait Freezing in Parkinson's Disease

Sponsors

Lead sponsor: Beth Israel Deaconess Medical Center

Source Beth Israel Deaconess Medical Center
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.

Overall Status Completed
Start Date April 2006
Completion Date June 2009
Primary Completion Date June 2009
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score. 2-3 months
Secondary Outcome
Measure Time Frame
Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature 2-3 months
Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue. 2-3 months
Percentage Change in Falls 1 to 2 months
Enrollment 32
Condition
Intervention

Intervention type: Device

Intervention name: 1 mo baseline before visual cue

Description: Laser Cane with Laser Accessory and/or U-Step Walker with Laser Accessory

Arm group label: 1 mo baseline

Other name: U-Step Walking Stabilizer

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
David K Simon, MD, PhD Principal Investigator Beth Israel Deaconess Medical Center
Location
facility
Beth Israel Deaconess Medical Center | Boston, Massachusetts, 02215, United States
The Neurological Institute of New York at Columbia University | New York, New York, 10032, United States
Location Countries

United States

Verification Date

June 2017

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Beth Israel Deaconess Medical Center

Investigator full name: David K. Simon

Investigator title: Associate Professor of Neurology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: 1 mo baseline

Arm group type: Active Comparator

Description: 1 mo baseline before visual cue: Cane or walker, no laserlight visual cue x 1 mo; + laserlight visual cue for 2nd mo

Arm group label: 2 month baseline

Arm group type: No Intervention

Description: Cane or walker, no laserlight visual cue x 2 mo, + laserlight visual cue for 3rd mo

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov