We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laser Light Cues for Gait Freezing in Parkinson's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00320242
First Posted: May 3, 2006
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David K. Simon, Beth Israel Deaconess Medical Center
April 28, 2006
May 3, 2006
December 23, 2015
July 14, 2017
July 14, 2017
April 2006
June 2009   (Final data collection date for primary outcome measure)
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.
  • Mean change in time to perform the timed gait test with versus without the laser feature based on performance at visit 2.
  • Mean change from baseline (visit 1) to endpoint (visit 3) in the freezing of gait questionnaire score.
Complete list of historical versions of study NCT00320242 on ClinicalTrials.gov Archive Site
  • 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.
  • Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3.
  • 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).
  • 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.
Not Provided
Not Provided
 
Laser Light Cues for Gait Freezing in Parkinson's Disease
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.
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Parkinson's Disease
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
  • 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
    Intervention: Device: 1 mo baseline before visual cue
  • No Intervention: 2 month baseline
    Cane or walker, no laserlight visual cue x 2 mo, + laserlight visual cue for 3rd mo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
June 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00320242
2006P000085
No
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
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.
David K. Simon, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Not Provided
Principal Investigator: David K Simon, MD, PhD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP