Back to resultsMobilaser Study to Help With People Who Are Having Problems With Their Gait
Primary Purpose
Parkinson's Disease, Parkinsonism
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mobilaser
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Parkinsonism, Gait problems, Freezing gait
Eligibility Criteria
Inclusion Criteria:
- Parkinsonian patients with Freezing of Gait or Gait hesitation.
- Must have evidence of bradykinesia ambulating (stride reduction or reduced arm swing)
- Must have a constant caregiver
Exclusion Criteria:
- No cardiopulmonary contraindications to ambulation, e.g., unstable angina pectoris;
- Severe arthritis;
- Cerebellar or sensory ataxia;
- Recent knee or hip surgery
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobilaser
Arm Description
Patients will begin by collecting data at home without using the mobilaser. They will then be given the mobilaser to use at home for 6 weeks while they collect data on whether their gait has improved. They will then have to return the Mobilaser to the clinic and collect data at home for 3 days to see if there is a difference.
Outcomes
Primary Outcome Measures
Improvement in Gait
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01581645
Brief Title
Mobilaser Study to Help With People Who Are Having Problems With Their Gait
Official Title
Increasing Mobility in Parkinsonian Patients With Freezing of Gait and Gait Hypokinesia With an Adjustable, Attachable Laser (Mobilaser)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Does use of the Mobilaser reduce freezing of gait (FOG) and stride reduction in patients with Parkinson's disease and Parkinsonism.
Detailed Description
Can patients walk faster and have less freezing when using the mobilaser then when not using it
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Parkinsonism
Keywords
Parkinson's disease, Parkinsonism, Gait problems, Freezing gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobilaser
Arm Type
Experimental
Arm Description
Patients will begin by collecting data at home without using the mobilaser. They will then be given the mobilaser to use at home for 6 weeks while they collect data on whether their gait has improved. They will then have to return the Mobilaser to the clinic and collect data at home for 3 days to see if there is a difference.
Intervention Type
Device
Intervention Name(s)
Mobilaser
Other Intervention Name(s)
Laser, Walker with laser
Intervention Description
Patients will begin by collecting data at home without using the mobilaser. They will then be given the mobilaser to use at home for 6 weeks while they collect data on whether their gait has improved. They will then have to return the Mobilaser to the clinic and collect data at home for 3 days to see if there is a difference.
Primary Outcome Measure Information:
Title
Improvement in Gait
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinsonian patients with Freezing of Gait or Gait hesitation.
Must have evidence of bradykinesia ambulating (stride reduction or reduced arm swing)
Must have a constant caregiver
Exclusion Criteria:
No cardiopulmonary contraindications to ambulation, e.g., unstable angina pectoris;
Severe arthritis;
Cerebellar or sensory ataxia;
Recent knee or hip surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Van Gerpen, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
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Mobilaser Study to Help With People Who Are Having Problems With Their Gait
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