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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
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
 Device: Laser Cane and U-Step Walker with Laser Accessory
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 26
Study Start Date: April 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320242

Locations
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
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: David K Simon, MD, PhD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: David K. Simon, MD, PhD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00320242     History of Changes
Other Study ID Numbers: 2006-P-000085
Study First Received: April 28, 2006
Last Updated: July 31, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Parkinson's disease
laser cane
freezing of gait
visual cues

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 21, 2013