Sensory Cues for Freezing in Parkinson's Disease
Recruitment status was Not yet recruiting
|First Received Date ICMJE||May 3, 2006|
|Last Updated Date||June 22, 2006|
|Start Date ICMJE||July 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00322426 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Sensory Cues for Freezing in Parkinson's Disease|
|Official Title ICMJE||Effect of Randomized Patient-Triggered Sensory Cues for Freezing of Gait in Parkinson's Disease|
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.
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 ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Condition ICMJE||Parkinson's Disease|
|Intervention ICMJE||Device: Sensory Cueing Device|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Completion Date||January 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||40 Years to 95 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Australia|
|NCT Number ICMJE||NCT00322426|
|Other Study ID Numbers ICMJE||1-Schoffer|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Austin Health|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Austin Health|
|Verification Date||May 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP