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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jay A. Van Gerpen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01581645
First received: November 10, 2011
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Parkinson's Disease
Parkinsonism
Device: Mobilaser

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Improvement in Gait [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: May 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: November 10, 2011
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on August 21, 2014