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Laser Light Cues for Gait Freezing in Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00320242
First received: April 28, 2006
Last updated: July 31, 2009
Last verified: July 2009
History of Changes

April 28, 2006
July 31, 2009
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 ] [ Designated as safety issue: No ]
  • Mean change from baseline (visit 1) to endpoint (visit 3) in the freezing of gait questionnaire score.
  • Mean change in time to perform the timed gait test with versus without the laser feature based on performance at visit 2.
Complete list of historical versions of study NCT00320242 on ClinicalTrials.gov Archive Site
  • Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3. [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
  • 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
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson's Disease
Device: Laser Cane and U-Step Walker with Laser Accessory
Laser Cane with Laser Accessory and/or U-Step Walker with Laser Accessory
Other Name: U-Step Walking Stabilizer
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00320242
2006-P-000085
No
David K. Simon, MD, PhD, 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
July 2009

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