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Sensory Cues for Freezing in Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Sensory Cueing Device
Sponsored by
Austin Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Freezing of Gait, Parkinson's Disease, Sensory Cues

Eligibility Criteria

40 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Currently living in Melbourne, Australia (note that we cannot respond to enquiries from outside of this area) Confirmed diagnosis of Parkinson's disease Stabilized drug therapy for at least 1 month prior to the study and during Hearing and vision - Able to identify lines on floor, hear metronome MMSE >24 Able to walk independently (with or without a mechanical aid) Able to give informed consent Exclusion Criteria: Severe comorbidity (joint problems, neuromuscular disorder affecting mobility) Severe dyskinesias

Sites / Locations

  • Austin Hospital

Outcomes

Primary Outcome Measures

Total walking time
Number of freezes
Freeze time - duration of walk in which patient experiences freezing
Walking time - duration of walk during which patient is not experiencing freezing
Average duration of freeze

Secondary Outcome Measures

Full Information

First Posted
May 3, 2006
Last Updated
June 22, 2006
Sponsor
Austin Health
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1. Study Identification

Unique Protocol Identification Number
NCT00322426
Brief Title
Sensory Cues for Freezing in Parkinson's Disease
Official Title
Effect of Randomized Patient-Triggered Sensory Cues for Freezing of Gait in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Austin Health

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is (1) to determine if patient triggered sensory(auditory, visual and tactile) cues can help treat freezing of gait in Parkinson's disease, and (2) to assess if unexpected (randomized) cues are more effective than anticipated ones.
Detailed Description
Freezing of gait (FOG) is defined as a transient halt in motor activity, wherein the patient appears "as if nailed to the floor." It is a common phenomenon in Parkinson's disease (PD), both when medications are at their peak ("on state") and at their lowest effectiveness ("off state"). While "off" FOG often responds to dopaminergic medications, "on" FOG is a difficult to treat, causing significant distress for the patient, and elevating risk of falls and morbidity. A few small studies have suggested that auditory and visual sensory cues, in the form of continuous stimuli such as a clicking metronome, music, or horizontal lines drawn the floor, may help patients with gait freezing. In this study, we aim to: (1) evaluate if stimuli (including visual, auditory as well as tactile cues) which are present only on patient triggering are effective for FOG in PD; (2) investigate if presentation of unexpected cues, in the form of randomized sensory stimuli, are more effective that anticipated cues. Participants will include patients diagnosed with PD, stabilized on drug therapy, with adequate vision, hearing, and mentation to respond to cuing, and experiencing "on" FOG. Patients will be evaluated during a single session. A small device which we have developed will be placed around the neck, and emit either repetitive beeping, a flashing line on the floor, or a slight vibration felt over the neck when the patient presses a button on the front panel in response to FOG. Participants will be videotaped walking a 15 m strip with: (1) no cues; (2) auditory cues only; (3) visual cues only; (4) tactile cues only; and (5) randomized cues. The order in which patients receive the cues will be randomized. A reviewer will watch the videotape with sound off so that they will be blinded to the cues. The Total Time, Freezing Time (duration of walk in which patient experiences freezing, Walking Time (duration of walk during which patient is not experiencing freezing), and Average Duration of Freeze will be recorded for each walk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Freezing of Gait, Parkinson's Disease, Sensory Cues

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Sensory Cueing Device
Primary Outcome Measure Information:
Title
Total walking time
Title
Number of freezes
Title
Freeze time - duration of walk in which patient experiences freezing
Title
Walking time - duration of walk during which patient is not experiencing freezing
Title
Average duration of freeze

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently living in Melbourne, Australia (note that we cannot respond to enquiries from outside of this area) Confirmed diagnosis of Parkinson's disease Stabilized drug therapy for at least 1 month prior to the study and during Hearing and vision - Able to identify lines on floor, hear metronome MMSE >24 Able to walk independently (with or without a mechanical aid) Able to give informed consent Exclusion Criteria: Severe comorbidity (joint problems, neuromuscular disorder affecting mobility) Severe dyskinesias
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kerrie Schoffer, MD
Phone
03-9496-2085
Email
Kerrie.SCHOFFER@austin.org.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerrie Schoffer, MD
Organizational Affiliation
Austin Hospital, Melbourne Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kerrie Schoffer, MD

12. IPD Sharing Statement

Learn more about this trial

Sensory Cues for Freezing in Parkinson's Disease

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