Laser Light Cues for Gait Freezing in Parkinson's Disease - Full Text View

Sponsored by:	Beth Israel Deaconess Medical Center
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00320242

Purpose

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.

Condition	Intervention	Phase
Parkinson's Disease	Device: Laser Cane and U-Step Walker with Laser Accessory	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
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.

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

Mean change in time to perform the timed gait test with versus without the laser feature based on performance at visit 2. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Mean change from baseline (visit 1) to endpoint (visit 3) in the freezing of gait questionnaire score. [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3. [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
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). [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
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. [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	April 2006
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320242

Contacts

Contact: David K Simon, MD, PhD	617-667-2699	dsimon1@bidmc.harvard.edu
Contact: Chen E Lim, BA	617-667-9890	celim@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: David K Simon, MD, PhD 617-667-2699 dsimon1@bidmc.harvard.edu
Contact: Chen E Lim, BA 617-667-9890 celim@bidmc.harvard.edu
Principal Investigator: David K Simon, MD, PhD
Sub-Investigator: Chen E Lim, BA
Sub-Investigator: Peggy Rose, BSN, RN
United States, New York
The Neurological Institute of New York at Columbia University	Recruiting
New York, New York, United States, 10032
Contact: Stanley Fahn, MD 212-305-5277
Principal Investigator: Stanley Fahn, MD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

Principal Investigator:

David K Simon, MD, PhD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	Beth Israel Deaconess Medical Center ( David K. Simon, MD, PhD )
Study ID Numbers:	2006-P-000085
Study First Received:	April 28, 2006
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00320242 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Parkinson's disease
laser cane
freezing of gait
visual cues

Study placed in the following topic categories:

Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on July 02, 2009