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

NCT01502995 | Completed Phase 3

• 1 other identifier: 00583
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Time to complete walking task

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

  Two hours

Secondary Outcomes (2)

• Number of steps

  Two hours

• Number of freezing episodes

  Two hours

Study Arms (2)

With laser light

ACTIVE COMPARATOR

Trial of walking tasks using laser light on walker.

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

Without laser light

ACTIVE COMPARATOR

Trial of walking task without laser light on walker.

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

Interventions

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.

Also known as: U-Step Walking Stabilizer with laser light

With laser light; Without laser light

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Parkinson's Disease Research, Education, and Clinical Center, Philadelphia: lead

Study Sites (1)

Philadelphia VA Medical Center PADRECC

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Interventions

Lasers

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Lisette Bunting-Perry, PhD, RN

  Philadelphia VAMC PADRECC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: January 2, 2012
• Study Start: June 1, 2003
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: January 2, 2012

Record last verified: 2011-12

Locations

US (1)