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

Phase 3

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Laser light (U-Step Walking Stabilizer with laser light)

• Registration Number: NCT01502995
• Lead Sponsor: Parkinson's Disease Research, Education, and Clinical Center, Philadelphia

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.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Status Verified: 2011-12
• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-30
• Last Update Submitted: 2011-12-30
• Study First Posted: 2012-01-02
• Last Update Posted: 2012-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
With laser light	Laser light (U-Step Walking Stabilizer with laser light)	Trial of walking tasks using laser light on walker.
Without laser light	Laser light (U-Step Walking Stabilizer with laser light)	Trial of walking task without laser light on walker.

Primary Outcome Measures

Name	Time	Method
Time to complete walking task	Two hours	Time in seconds for subject to complete the designated walking task.

Secondary Outcome Measures

Name	Time	Method
Number of steps	Two hours	Number of steps taken to complete the designated walking task.
Number of freezing episodes	Two hours	Number of freezing episodes that occur during walking task.

Trial Locations

Locations (1)

Philadelphia VA Medical Center PADRECC; 🇺🇸 Philadelphia, Pennsylvania, United States