Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322426
Status:
UNKNOWN
Last Update Posted:
2006-06-23
First Post:
2006-05-03
Brief Title:
Sensory Cues for Freezing in Parkinsons Disease
Sponsor:
Austin Health
Organization:
Austin Health
Study Overview
Official Title:
Effect of Randomized Patient-Triggered Sensory Cues for Freezing of Gait in Parkinsons Disease
Status:
UNKNOWN
Status Verified Date:
2006-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is 1 to determine if patient triggered sensoryauditory visual and tactile cues can help treat freezing of gait in Parkinsons 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 Parkinsons 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None