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Completed

NCT Number: NCT01502995

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mobility Limitation Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Philadelphia VA Medical Center PADRECC

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser light (U-Step Walking Stabilizer with laser light)

Device

Use of a laser light on a rolling walker during episodes of freezing of gait.

Other names: U-Step Walking Stabilizer with laser light

Primary outcomes

  1. Time to complete walking task

    Time frame: Two hours

    Time in seconds for subject to complete the designated walking task.

Secondary outcomes

  1. Number of steps

    Time frame: Two hours

    Number of steps taken to complete the designated walking task.

  2. Number of freezing episodes

    Time frame: Two hours

    Number of freezing episodes that occur during walking task.

Sponsors and collaborators

Lead sponsor

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

Fed

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jan 2, 2012
Registry last updated
Jan 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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