Laser Light Cues for Gait Freezing in Parkinson's Disease

Beth Israel Lahey Health

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: 1 mo baseline before visual cue

Study type: Interventional

Funder types: Other

Identifiers

NCT00320242

2006P000085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

1 mo baseline

Active Comparator group

Description:

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

Treatment:

Device: 1 mo baseline before visual cue

2 month baseline

No Intervention group

Description:

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