Laser Light Cues for Gait Freezing in Parkinson's Disease
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00320242 |
Recruitment Status :
Completed
First Posted : May 3, 2006
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease | Device: 1 mo baseline before visual cue | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
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. |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | June 2009 |

Arm | Intervention/treatment |
---|---|
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
|
- 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 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320242
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 |
Principal Investigator: | David K Simon, MD, PhD | Beth Israel Deaconess Medical Center |
Responsible Party: | David K. Simon, Associate Professor of Neurology, Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00320242 |
Other Study ID Numbers: |
2006P000085 |
First Posted: | May 3, 2006 Key Record Dates |
Results First Posted: | July 14, 2017 |
Last Update Posted: | July 14, 2017 |
Last Verified: | June 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 |
Parkinson's disease laser cane freezing of gait visual cues |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |