Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes in patients with Parkinson's disease.

Detailed Description
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Freezing of gait is a debilitating feature of Parkinson's disease. This study aims to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes. Patients will perform two trials of 3 timed walking tasks: once with the laser beam and once without. For each trial, the time to complete, number of steps, and number of freezing episodes will be recorded. Patients will be randomized to perform the first trial either with the light or without the light, to control for fatigue.

Official Title
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Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Laser light (U-Step Walking Stabilizer with laser light)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: idiopathic PD confirmed by a movement disorders neurologist a Mini-Mental Status Examination (MMSE)[13] score ≥ 24 to ensure competence to participate in informed consent and an ability to learn procedurally the use of the rolling walker with laser beam functional visual acuity for recognizing the laser beam on the rolling walker FOG in both on and off medication states, as indicated by a score of ≥ 2 on Item 14 of the Unified Parkinson's Disease Rating Scale (UPDRS) and/or ≥1 on Item 3 of the Freezing of Gait Questionnaire (FOGQ) ability to ambulate for at least household distances with or without an assistive device as indicated by scoring 0, 1, or 2 on Items 15 and 29 of the UPDRS. Exclusion Criteria: diagnosis of a gait disorder other than Parkinson's disease
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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: With laser light<br>Trial of walking tasks using laser light on walker. | Device: Laser light (U-Step Walking Stabilizer with laser light)<br>* Use of a laser light on a rolling walker during episodes of freezing of gait.<br>* Other names: U-Step Walking Stabilizer with laser light;|
| Active Comparator: Without laser light<br>Trial of walking task without laser light on walker. | Device: Laser light (U-Step Walking Stabilizer with laser light)<br>* Use of a laser light on a rolling walker during episodes of freezing of gait.<br>* Other names: U-Step Walking Stabilizer with laser light;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete walking task | Time in seconds for subject to complete the designated walking task. | Two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of steps | Number of steps taken to complete the designated walking task. | Two hours | 
| Number of freezing episodes | Number of freezing episodes that occur during walking task. | Two hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walker, Assistive devices, Freezing of gait, Gait disorders, Gait hesitation, Gait ignition failure, Laser light, Parkinson's disease, Rolling walker, Visual Cue