Laser Light Cues for Gait Freezing in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320242
• Other study ID #: 2006-P-000085
• Status: Completed
• Phase: Phase 3
• First received: April 28, 2006
• Last updated: July 31, 2009
• Start date: April 2006
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	The Neurological Institute of New York at Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3.		2-3 months	No
Secondary	Mean change in falls per month for the period between visit 1 and visit 2 (without laser) compared to the period between visit 2 and visit 3 (with the laser).		2-3 months	No
Secondary	Comparison of the changes in falls and the Freezing of Gait Questionnaire scores for group 1 versus group 2 based on the change from the first month after baseline visit to the second month after the baseline visit.		2-3 months	No