Laser Light Cues for Gait Freezing in Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: 1 mo baseline before visual cue


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 mo baseline<br>1 mo baseline before visual cue: Cane or walker, no laserlight visual cue x 1 mo; + laserlight visual cue for 2nd mo | Device: 1 mo baseline before visual cue<br>* Laser Cane with Laser Accessory and/or U-Step Walker with Laser Accessory<br>* Other names: U-Step Walking Stabilizer;|
| No Intervention: 2 month baseline<br>Cane or walker, no laserlight visual cue x 2 mo, + laserlight visual cue for 3rd mo | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. | The FOGQ has a minimum of 0 and max of 4 for each question, with 4 representing more severe freezing of gait. There are 6 questions, so the total score ranges from 0 to 24. It was pre-specified that all 26 subjects were treated as a single group with respect to the primary outcome measure regardless of whether or not they had a 1 month or 2 month baseline period. | 2-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature | Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3. It was pre-specified that all 26 subjects would be treated as a single group with respect to the outcome measure regardless of whether or not they had a 1 month or 2 month baseline period | 2-3 months | 
| Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue. | Mean change in falls per week for the period between visit 1 and visit 2 (without laserlight visual cue) compared to the period between visit 2 and visit 3 (with the laserlight visual cue). | 2-3 months | 
| Percentage Change in Falls | The mean change in fall frequency from the baseline period without the laserlight visual cue compared to the subsequent period during which they used the laserlight visual cue among subjects experiencing at least one fall during the baseline and subsequent study periods. This outcome measure is expressed as a percentage change from the baseline period. | 1 to 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, laser cane, freezing of gait, visual cues