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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

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
Enrollment 32

Recruitment Details All subjects were recruited by movement disorders specialists seen during their clinic visits at either of the 2 participating hospitals
Pre-assignment Details 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.
Arm/Group Title 1 mo Baseline Before Visual Cue 2 Month Baseline Before Visual Cue
Hide Arm/Group Description 1 mo baseline using the cane/walker without the laserlight visual cue, followed by additional time using the 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.
Period Title: Overall Study
Started 16 16
Completed 14 12
Not Completed 2 4
Arm/Group Title All Study Participants Who Completed Protocol
Hide Arm/Group Description This analysis includes all study participants who completed the protocol (n = 26)
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  38.5%
>=65 years
16
  61.5%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 26 participants
71
(58 to 92)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
5
  19.2%
Male
21
  80.8%
[1]
Measure Description: Gender distribution: male versus female
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
[1]
Measure Description: Regions of subject enrollment
1.Primary Outcome
Title Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score.
Hide Description 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.
Time Frame 2-3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These 13 subjects were those who were reandomized to a 1 month baseline before use of the laserlight visual cue.
Arm/Group Title 1 Month Baseline Before Use of Laserlight Visual Cue
Hide Arm/Group Description:
subjects had a 1 month baseline before use of laserlight visual cue
Overall Number of Participants Analyzed 13
Mean (Standard Error)
Unit of Measure: change in FOGQ score
1.25  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 Month Baseline Before Use of Laserlight Visual Cue
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0152
Comments [Not Specified]
Method t-test, 2 sided
Comments two-tailed paired t-test
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.26 to 2.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.48
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature
Hide Description 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
Time Frame 2-3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All 26 subjects who entered the study and completed the protocol, so this excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue
Arm/Group Title All Study Participants Who Completed Protocol
Hide Arm/Group Description:
All 26 subjects who entered the study and completed the study protocol.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: seconds
Before laserlingh visual cue 65  (26.2)
With the laserlight visual cue 57.6  (23.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants Who Completed Protocol
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 50
Confidence Interval (2-Sided) 95%
23.9 to 76.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 11.7
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue.
Hide Description 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).
Time Frame 2-3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue
Arm/Group Title All Study Participants Who Completed Protocol
Hide Arm/Group Description:
All 26 Study Participants who completed protocol. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: falls per week
without laserlight visual cue 3.23  (1.31)
with laserlight visual cue 2.12  (0.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Study Participants Who Completed Protocol
Comments two-tailed Wilcoxan signed-rank sum test
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments two-tailed Wilcoxan signed-rank sum test
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.11
Parameter Dispersion
Type: Standard Deviation
Value: 1.31
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage Change in Falls
Hide Description 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.
Time Frame 1 to 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
10 Study Participants who completed protocol and who met a predetermined criterion for this subgroup analysis by experiencing one or more falls during both baseline and the subsequent study period. This excludes the 6 subjects who dropped out before any exposure to the laserlight visual cue
Arm/Group Title 1 or 2 Month Baseline Before Use of Laserlight Visual Cue
Hide Arm/Group Description:
subjects had a 1 month baseline before use of laserlight visual cue
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: % change in fall frequency
39.5  (9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 or 2 Month Baseline Before Use of Laserlight Visual Cue
Comments The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0
Type of Statistical Test Other
Comments The percentage change in falls was analyzed using a two-tailed one-sample t-test with a hypothesized mean of 0
Statistical Test of Hypothesis P-Value 0.002
Comments Two-tailed one-sample t-test with a hypothesized mean of 0. This analysis was not adjusted for multiple comparisons.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Average of 6.5 weeks per subject
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Participants
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Study Participants
Affected / at Risk (%)
Total   0/26 (0.00%) 
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
Responsible Party: David K. Simon, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00320242     History of Changes
Other Study ID Numbers: 2006P000085
First Submitted: April 28, 2006
First Posted: May 3, 2006
Results First Submitted: December 23, 2015
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017