NCT01581645

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 31, 2015

Status Verified

April 1, 2015

Enrollment Period

1.6 years

First QC Date

November 10, 2011

Last Update Submit

December 30, 2015

Conditions

Parkinson's DiseaseParkinsonism

Keywords

Parkinson's diseaseParkinsonismGait problemsFreezing gait

Outcome Measures

Primary Outcomes (1)

  • Improvement in Gait

    6 weeks

Study Arms (1)

Mobilaser

EXPERIMENTAL

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

Interventions

MobilaserDEVICE

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.

Also known as: Laser, Walker with laser
Mobilaser

Eligibility Criteria

Age30 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No cardiopulmonary contraindications to ambulation, e.g., unstable angina pectoris;
  • Severe arthritis;
  • Cerebellar or sensory ataxia;
  • Recent knee or hip surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian DisordersMobility Limitation

Interventions

LasersWalkers

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and SuppliesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Jay Van Gerpen, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

November 10, 2011

First Posted

April 20, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 31, 2015

Record last verified: 2015-04

Locations

US(1)