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
Parkinson's Disease	Device: 1 mo baseline before visual cue


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (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

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Further study details as provided by David K. Simon, 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 ]
The FOGQ has a minimum of 0 and max of 4 for each question, with 4 representing more severe freezing of gait. There are 6 questions, so the total score ranges from 0 to 24. It was pre-specified that all 26 subjects were treated as a single group with respect to the primary outcome measure regardless of whether or not they had a 1 month or 2 month baseline period.

Secondary Outcome Measures:

Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature [ Time Frame: 2-3 months ]
Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3. It was pre-specified that all 26 subjects would be treated as a single group with respect to the outcome measure regardless of whether or not they had a 1 month or 2 month baseline period
Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue. [ Time Frame: 2-3 months ]
Mean change in falls per week for the period between visit 1 and visit 2 (without laserlight visual cue) compared to the period between visit 2 and visit 3 (with the laserlight visual cue).
Percentage Change in Falls [ Time Frame: 1 to 2 months ]
The mean change in fall frequency from the baseline period without the laserlight visual cue compared to the subsequent period during which they used the laserlight visual cue among subjects experiencing at least one fall during the baseline and subsequent study periods. This outcome measure is expressed as a percentage change from the baseline period.


Enrollment:	32
Study Start Date:	April 2006
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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	Device: 1 mo baseline before visual cue Laser Cane with Laser Accessory and/or U-Step Walker with Laser Accessory Other Name: U-Step Walking Stabilizer
No Intervention: 2 month baseline Cane or walker, no laserlight visual cue x 2 mo, + laserlight visual cue for 3rd mo

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)
Sexes Eligible for Study:	All
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

Publications:

Donovan S, Lim C, Diaz N, Browner N, Rose P, Sudarsky LR, Tarsy D, Fahn S, Simon DK. Laserlight cues for gait freezing in Parkinson's disease: an open-label study. Parkinsonism Relat Disord. 2011 May;17(4):240-5. doi: 10.1016/j.parkreldis.2010.08.010. Epub 2010 Sep 3.


Responsible Party:	David K. Simon, Associate Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00320242 History of Changes
Other Study ID Numbers:	2006P000085
Study First Received:	April 28, 2006
Results First Received:	December 23, 2015
Last Updated:	June 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	Some individual participant data was included in the publication. There is no plan to share additional individual participant data.


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Pediatric Postmarket Surveillance of a Device Product:		No

Keywords provided by David K. Simon, 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 18, 2017