Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Laser light (U-Step Walking Stabilizer with laser light)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Assistive devices, Freezing of gait, Gait disorders, Gait hesitation, Gait ignition failure, Laser light, Parkinson's disease, Rolling walker, Visual Cue, Walker
Eligibility 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
Sites / Locations
- Philadelphia VA Medical Center PADRECC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
With laser light
Without laser light
Arm Description
Trial of walking tasks using laser light on walker.
Trial of walking task without laser light on walker.
Outcomes
Primary Outcome Measures
Time to complete walking task
Time in seconds for subject to complete the designated walking task.
Secondary Outcome Measures
Number of steps
Number of steps taken to complete the designated walking task.
Number of freezing episodes
Number of freezing episodes that occur during walking task.
Full Information
NCT ID
NCT01502995
First Posted
December 21, 2011
Last Updated
December 30, 2011
Sponsor
Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT01502995
Brief Title
Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease
Official Title
Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Assistive devices, Freezing of gait, Gait disorders, Gait hesitation, Gait ignition failure, Laser light, Parkinson's disease, Rolling walker, Visual Cue, Walker
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
With laser light
Arm Type
Active Comparator
Arm Description
Trial of walking tasks using laser light on walker.
Arm Title
Without laser light
Arm Type
Active Comparator
Arm Description
Trial of walking task without laser light on walker.
Intervention Type
Device
Intervention Name(s)
Laser light (U-Step Walking Stabilizer with laser light)
Other Intervention Name(s)
U-Step Walking Stabilizer with laser light
Intervention Description
Use of a laser light on a rolling walker during episodes of freezing of gait.
Primary Outcome Measure Information:
Title
Time to complete walking task
Description
Time in seconds for subject to complete the designated walking task.
Time Frame
Two hours
Secondary Outcome Measure Information:
Title
Number of steps
Description
Number of steps taken to complete the designated walking task.
Time Frame
Two hours
Title
Number of freezing episodes
Description
Number of freezing episodes that occur during walking task.
Time Frame
Two hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisette Bunting-Perry, PhD, RN
Organizational Affiliation
Philadelphia VAMC PADRECC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia VA Medical Center PADRECC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease
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