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Trial record 2 of 92 for:    light | Parkinson Disease

Laser Light Visual Cueing for Freezing of Gait 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: NCT01502995
Recruitment Status : Completed
First Posted : January 2, 2012
Last Update Posted : January 2, 2012
Sponsor:
Information provided by (Responsible Party):
Parkinson's Disease Research, Education, and Clinical Center, Philadelphia

Brief Summary:
The purpose of this study is to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes in patients with Parkinson's disease.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Laser light (U-Step Walking Stabilizer with laser light) Phase 3

Detailed Description:
Freezing of gait is a debilitating feature of Parkinson's disease. This study aims to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes. Patients will perform two trials of 3 timed walking tasks: once with the laser beam and once without. For each trial, the time to complete, number of steps, and number of freezing episodes will be recorded. Patients will be randomized to perform the first trial either with the light or without the light, to control for fatigue.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease
Study Start Date : June 2003
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: With laser light
Trial of walking tasks using laser light on walker.
Device: Laser light (U-Step Walking Stabilizer with laser light)
Use of a laser light on a rolling walker during episodes of freezing of gait.
Other Name: U-Step Walking Stabilizer with laser light

Active Comparator: Without laser light
Trial of walking task without laser light on walker.
Device: Laser light (U-Step Walking Stabilizer with laser light)
Use of a laser light on a rolling walker during episodes of freezing of gait.
Other Name: U-Step Walking Stabilizer with laser light




Primary Outcome Measures :
  1. Time to complete walking task [ Time Frame: Two hours ]
    Time in seconds for subject to complete the designated walking task.


Secondary Outcome Measures :
  1. Number of steps [ Time Frame: Two hours ]
    Number of steps taken to complete the designated walking task.

  2. Number of freezing episodes [ Time Frame: Two hours ]
    Number of freezing episodes that occur during walking task.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • idiopathic PD confirmed by a movement disorders neurologist
  • a Mini-Mental Status Examination (MMSE)[13] score ≥ 24 to ensure competence to participate in informed consent and an ability to learn procedurally the use of the rolling walker with laser beam
  • functional visual acuity for recognizing the laser beam on the rolling walker
  • FOG in both on and off medication states, as indicated by a score of ≥ 2 on Item 14 of the Unified Parkinson's Disease Rating Scale (UPDRS) and/or ≥1 on Item 3 of the Freezing of Gait Questionnaire (FOGQ)
  • ability to ambulate for at least household distances with or without an assistive device as indicated by scoring 0, 1, or 2 on Items 15 and 29 of the UPDRS.

Exclusion Criteria:

  • diagnosis of a gait disorder other than Parkinson's disease

Information from the National Library of Medicine

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): NCT01502995


Locations
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United States, Pennsylvania
Philadelphia VA Medical Center PADRECC
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
Investigators
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Principal Investigator: Lisette Bunting-Perry, PhD, RN Philadelphia VAMC PADRECC
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Responsible Party: Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
ClinicalTrials.gov Identifier: NCT01502995    
Other Study ID Numbers: 00583
First Posted: January 2, 2012    Key Record Dates
Last Update Posted: January 2, 2012
Last Verified: December 2011
Keywords provided by Parkinson's Disease Research, Education, and Clinical Center, Philadelphia:
Assistive devices
Freezing of gait
Gait disorders
Gait hesitation
Gait ignition failure
Laser light
Parkinson's disease
Rolling walker
Visual Cue
Walker
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases