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

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

Status and phase: Completed; Phase 3

Conditions: Parkinson Disease

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01502995

00583

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

With laser light

Active Comparator group

Description:

Trial of walking tasks using laser light on walker.

Treatment:

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

Without laser light

Active Comparator group

Description:

Trial of walking task without laser light on walker.

Treatment:

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