Sensory Cues for Freezing in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT00322426|
Recruitment Status : Unknown
Verified May 2006 by Austin Health.
Recruitment status was: Not yet recruiting
First Posted : May 5, 2006
Last Update Posted : June 23, 2006
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: Sensory Cueing Device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Effect of Randomized Patient-Triggered Sensory Cues for Freezing of Gait in Parkinson's Disease|
|Study Start Date :||July 2006|
|Study Completion Date :||January 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322426
|Contact: Kerrie Schoffer, MD||03-9496-2085||Kerrie.SCHOFFER@austin.org.au|
|Austin Hospital||Not yet recruiting|
|Melbourne, Victoria, Australia, 3084|
|Principal Investigator: Kerrie Schoffer, MD|
|Principal Investigator:||Kerrie Schoffer, MD||Austin Hospital, Melbourne Australia|