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Laser Light Cues for Gait Freezing in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT00320242
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
David K. Simon, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE April 28, 2006
First Posted Date  ICMJE May 3, 2006
Results First Submitted Date  ICMJE December 23, 2015
Results First Posted Date  ICMJE July 14, 2017
Last Update Posted Date July 14, 2017
Study Start Date  ICMJE April 2006
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2006)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2006)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laser Light Cues for Gait Freezing in Parkinson's Disease
Official Title  ICMJE 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.
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2017)
32
Original Enrollment  ICMJE
 (submitted: April 28, 2006)
36
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00320242
Other Study ID Numbers  ICMJE 2006P000085
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
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.
Responsible Party David K. Simon, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David K Simon, MD, PhD Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date June 2017

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