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Laser Light Cues for Gait Freezing in Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David K. Simon, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00320242
First received: April 28, 2006
Last updated: June 16, 2017
Last verified: June 2017
Results First Received: December 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Parkinson's Disease
Intervention: Device: 1 mo baseline before visual cue

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All subjects were recruited by movement disorders specialists seen during their clinic visits at either of the 2 participating hospitals

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
6 of the original 32 subjects who had agreed to participate in the study dropped out before any exposure to the laserlight visual cue. Therefore, data are presented only for the 26 subjects who actually participated in the study, includign exposure to this laserlight visual cue.

Reporting Groups
  Description
1 mo Baseline Before Visual Cue 1 mo baseline using the cane/walker without the laserlight visual cue, followed by additional time using the visual cue
2 Month Baseline Before Visual Cue 2 month baseline using the laserlight visual cue, followed by 1 additional month using the laserlight visual cue. This group served as an active comparator control for comparison with Group 1during the 2nd month, when group 1 did use the visual cue but group 2 continued without the visual cue.

Participant Flow:   Overall Study
    1 mo Baseline Before Visual Cue   2 Month Baseline Before Visual Cue
STARTED   16   16 
COMPLETED   14   12 
NOT COMPLETED   2   4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
32 subjects initially signed the consent form, but 6 dropped out prior to any exposure to the laserlight visual cue. Therefore, data in this study are included for the 26 subjects who entered the study and were eventually exposed to the laserlight visual cue.

Reporting Groups
  Description
All Study Participants Who Completed Protocol This analysis includes all study participants who completed the protocol (n = 26)

Baseline Measures
   All Study Participants Who Completed Protocol 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      10  38.5% 
>=65 years      16  61.5% 
Age 
[Units: Years]
Mean (Full Range)
 71 
 (58 to 92) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Female      5  19.2% 
Male      21  80.8% 
[1] Gender distribution: male versus female
Region of Enrollment [1] 
[Units: Participants]
 
United States   26 
[1] Regions of subject enrollment


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature   [ Time Frame: 2-3 months ]

3.  Secondary:   Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue.   [ Time Frame: 2-3 months ]

4.  Secondary:   Percentage Change in Falls   [ Time Frame: 1 to 2 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. David K. Simon, Associate Professor of Neurology
Organization: Beth Israel Deaconess Medical Center and Harvard Medical School
phone: 617-735-3251
e-mail: dsimon1@bidmc.harvard.edu


Publications:

Responsible Party: David K. Simon, 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