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| Sponsored by: |
Beth Israel Deaconess Medical Center |
|---|---|
| Information provided by: | Beth Israel Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00320242 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
| 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. |
| Estimated Enrollment: | 36 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: David K Simon, MD, PhD | 617-667-2699 | dsimon1@bidmc.harvard.edu |
| Contact: Chen E Lim, BA | 617-667-9890 | celim@bidmc.harvard.edu |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: David K Simon, MD, PhD 617-667-2699 dsimon1@bidmc.harvard.edu | |
| Contact: Chen E Lim, BA 617-667-9890 celim@bidmc.harvard.edu | |
| Principal Investigator: David K Simon, MD, PhD | |
| Sub-Investigator: Chen E Lim, BA | |
| Sub-Investigator: Peggy Rose, BSN, RN | |
| United States, New York | |
| The Neurological Institute of New York at Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Stanley Fahn, MD 212-305-5277 | |
| Principal Investigator: Stanley Fahn, MD | |
| Principal Investigator: | David K Simon, MD, PhD | Beth Israel Deaconess Medical Center |
More Information
| Responsible Party: | Beth Israel Deaconess Medical Center ( David K. Simon, MD, PhD ) |
| Study ID Numbers: | 2006-P-000085 |
| Study First Received: | April 28, 2006 |
| Last Updated: | January 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00320242 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Parkinson's disease laser cane freezing of gait visual cues |
|
Ganglion Cysts Movement Disorders Parkinson Disease Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |
|
Movement Disorders Parkinson Disease Nervous System Diseases Basal Ganglia Diseases |
Central Nervous System Diseases Parkinsonian Disorders Neurodegenerative Diseases Brain Diseases |