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Mobilaser Study to Help With People Who Are Having Problems With Their Gait

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ClinicalTrials.gov Identifier: NCT01581645
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
Jay A. Van Gerpen, Mayo Clinic

Brief Summary:
Does use of the Mobilaser reduce freezing of gait (FOG) and stride reduction in patients with Parkinson's disease and Parkinsonism.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Parkinsonism Device: Mobilaser Early Phase 1

Detailed Description:
Can patients walk faster and have less freezing when using the mobilaser then when not using it

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Increasing Mobility in Parkinsonian Patients With Freezing of Gait and Gait Hypokinesia With an Adjustable, Attachable Laser (Mobilaser)
Study Start Date : May 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mobilaser
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.
Device: Mobilaser
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.
Other Names:
  • Laser
  • Walker with laser




Primary Outcome Measures :
  1. Improvement in Gait [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01581645


Locations
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jay Van Gerpen, MD Mayo Clinic

Responsible Party: Jay A. Van Gerpen, Assistant Professor of Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01581645     History of Changes
Other Study ID Numbers: 10-002978
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: April 2015

Keywords provided by Jay A. Van Gerpen, Mayo Clinic:
Parkinson's disease
Parkinsonism
Gait problems
Freezing gait

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