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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Laser light (U-Step Walking Stabilizer with laser light)
Sponsored by
Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Assistive devices, Freezing of gait, Gait disorders, Gait hesitation, Gait ignition failure, Laser light, Parkinson's disease, Rolling walker, Visual Cue, Walker

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Philadelphia VA Medical Center PADRECC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

With laser light

Without laser light

Arm Description

Trial of walking tasks using laser light on walker.

Trial of walking task without laser light on walker.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of steps
Number of steps taken to complete the designated walking task.
Number of freezing episodes
Number of freezing episodes that occur during walking task.

Full Information

First Posted
December 21, 2011
Last Updated
December 30, 2011
Sponsor
Parkinson's Disease Research, Education, and Clinical Center, Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT01502995
Brief Title
Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease
Official Title
Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parkinson's Disease Research, Education, and Clinical Center, Philadelphia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Assistive devices, Freezing of gait, Gait disorders, Gait hesitation, Gait ignition failure, Laser light, Parkinson's disease, Rolling walker, Visual Cue, Walker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With laser light
Arm Type
Active Comparator
Arm Description
Trial of walking tasks using laser light on walker.
Arm Title
Without laser light
Arm Type
Active Comparator
Arm Description
Trial of walking task without laser light on walker.
Intervention Type
Device
Intervention Name(s)
Laser light (U-Step Walking Stabilizer with laser light)
Other Intervention Name(s)
U-Step Walking Stabilizer with laser light
Intervention Description
Use of a laser light on a rolling walker during episodes of freezing of gait.
Primary Outcome Measure Information:
Title
Time to complete walking task
Description
Time in seconds for subject to complete the designated walking task.
Time Frame
Two hours
Secondary Outcome Measure Information:
Title
Number of steps
Description
Number of steps taken to complete the designated walking task.
Time Frame
Two hours
Title
Number of freezing episodes
Description
Number of freezing episodes that occur during walking task.
Time Frame
Two hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisette Bunting-Perry, PhD, RN
Organizational Affiliation
Philadelphia VAMC PADRECC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia VA Medical Center PADRECC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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

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