Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease

December 30, 2011 updated by: Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
The purpose of this study is to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes in patients with Parkinson's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Freezing of gait is a debilitating feature of Parkinson's disease. This study aims to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes. Patients will perform two trials of 3 timed walking tasks: once with the laser beam and once without. For each trial, the time to complete, number of steps, and number of freezing episodes will be recorded. Patients will be randomized to perform the first trial either with the light or without the light, to control for fatigue.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Philadelphia VA Medical Center PADRECC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • idiopathic PD confirmed by a movement disorders neurologist
  • a Mini-Mental Status Examination (MMSE)[13] score ≥ 24 to ensure competence to participate in informed consent and an ability to learn procedurally the use of the rolling walker with laser beam
  • functional visual acuity for recognizing the laser beam on the rolling walker
  • FOG in both on and off medication states, as indicated by a score of ≥ 2 on Item 14 of the Unified Parkinson's Disease Rating Scale (UPDRS) and/or ≥1 on Item 3 of the Freezing of Gait Questionnaire (FOGQ)
  • ability to ambulate for at least household distances with or without an assistive device as indicated by scoring 0, 1, or 2 on Items 15 and 29 of the UPDRS.

Exclusion Criteria:

  • diagnosis of a gait disorder other than Parkinson's disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: With laser light
Trial of walking tasks using laser light on walker.
Device: Laser light (U-Step Walking Stabilizer with laser light)
Use of a laser light on a rolling walker during episodes of freezing of gait.
Other Names:
  • U-Step Walking Stabilizer with laser light
Active Comparator: Without laser light
Trial of walking task without laser light on walker.
Device: Laser light (U-Step Walking Stabilizer with laser light)
Use of a laser light on a rolling walker during episodes of freezing of gait.
Other Names:
  • U-Step Walking Stabilizer with laser light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete walking task
Time Frame: Two hours
Time in seconds for subject to complete the designated walking task.
Two hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of steps
Time Frame: Two hours
Number of steps taken to complete the designated walking task.
Two hours
Number of freezing episodes
Time Frame: Two hours
Number of freezing episodes that occur during walking task.
Two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parkinson's Disease Research, Education, and Clinical Center, Philadelphia

Investigators

  • Principal Investigator: Lisette Bunting-Perry, PhD, RN, Philadelphia VAMC PADRECC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

December 21, 2011

First Submitted That Met QC Criteria

December 30, 2011

First Posted (Estimate)

January 2, 2012

Study Record Updates

Last Update Posted (Estimate)

January 2, 2012

Last Update Submitted That Met QC Criteria

December 30, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00583

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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