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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
ClinicalTrials.gov Identifier:
NCT01502995
First received: December 21, 2011
Last updated: December 30, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Device: Laser light (U-Step Walking Stabilizer with laser light)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Parkinson's Disease Research, Education, and Clinical Center, Philadelphia:

Primary Outcome Measures:
  • Time to complete walking task [ Time Frame: Two hours ] [ Designated as safety issue: No ]
    Time in seconds for subject to complete the designated walking task.


Secondary Outcome Measures:
  • Number of steps [ Time Frame: Two hours ] [ Designated as safety issue: No ]
    Number of steps taken to complete the designated walking task.

  • Number of freezing episodes [ Time Frame: Two hours ] [ Designated as safety issue: No ]
    Number of freezing episodes that occur during walking task.


Enrollment: 22
Study Start Date: June 2003
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: U-Step Walking Stabilizer with laser light

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01502995

Locations
United States, Pennsylvania
Philadelphia VA Medical Center PADRECC
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
Investigators
Principal Investigator: Lisette Bunting-Perry, PhD, RN Philadelphia VAMC PADRECC
  More Information

No publications provided

Responsible Party: Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
ClinicalTrials.gov Identifier: NCT01502995     History of Changes
Other Study ID Numbers: 00583
Study First Received: December 21, 2011
Last Updated: December 30, 2011
Health Authority: United States: Federal Government

Keywords provided by Parkinson's Disease Research, Education, and Clinical Center, Philadelphia:
Assistive devices
Freezing of gait
Gait disorders
Gait hesitation
Gait ignition failure
Laser light
Parkinson's disease
Rolling walker
Visual Cue
Walker

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 20, 2014