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

Parkinson's Disease Clinical Trial

Official title:

Increasing Mobility in Parkinsonian Patients With Freezing of Gait and Gait Hypokinesia With an Adjustable, Attachable Laser (Mobilaser)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581645
• Other study ID #: 10-002978
• Status: Completed
• Phase: Phase 0
• First received: November 10, 2011
• Last updated: December 30, 2015
• Start date: May 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 99 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Parkinsonian Disorders
• Parkinsonism

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Gait		6 weeks	No