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

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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: Parkinson disease Perry syndrome

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 from baseline (visit 1 until visit 2) to endpoint (after visit 2 until 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 ]


Enrollment:	26
Study Start Date:	April 2006
Study Completion Date:	June 2009
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

Other Name: U-Step Walking Stabilizer

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
The Neurological Institute of New York at Columbia University
New York, New York, United States, 10032

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators


Principal Investigator:	David K Simon, MD, PhD	Beth Israel Deaconess Medical Center

More Information


Responsible Party:	David K. Simon, MD, PhD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00320242 History of Changes
Other Study ID Numbers:	2006-P-000085
Study First Received:	April 28, 2006
Last Updated:	July 31, 2009
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

Additional relevant MeSH terms:


Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases	Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 26, 2016