Laser Light Cues for Gait Freezing in Parkinson's Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-06-30

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.

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 mo baseline

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

Group Type ACTIVE_COMPARATOR

1 mo baseline before visual cue

Intervention Type DEVICE

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

2 month baseline

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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1 mo baseline before visual cue

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

Intervention Type DEVICE

Other Intervention Names

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U-Step Walking Stabilizer

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No