An interventional study of behavioral intervention based on sensory cues in Parkinson Disease, sponsored by Seoul National University Hospital. Status unknown. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
The investigators aims to assess the effectiveness of behavioral interventions based on sensory cues on freezing of gait in patients with Parkinson's disease after bilateral subthalamic nucleus deep brain stimulation.
Freezing of gait (FOG) leads to falling and is one of the major determinants of quality of life and prognosis in Parkinson's disease (PD). Previous evidence suggests that subthalamic nucleus deep brain stimulation (STN-DBS) improve off-medication FOG but not on-medication FOG in patients with PD. Furthermore, off-mediation FOG persist or even worsen after STN-DBS in some PD patients.
Although visual and auditory cues are known to improve FOG in research setting, it is unclear whether these cues are effective for FOG in real clinical setting. Most previous studies have used wearable devices to use sensory cues, but such devices are difficult to apply in clinical practice.
Therefore, this study aims to investigate the effectiveness of behavioral interventions based on visual and auditory cues in patients with PD after bilateral STN-DBS. Participants undergo clinical evaluations including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Unified Parkinson 's Disease Rating Scale (UPDRS), Freezing of Gait-Questionnaire (FOG-Q), and the average number of falling over the last week. Then, participants receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice. To investigate the education effect, FOG-Q and the average number of falling over the last week are repetitively assessed at 2-week and 4-week follow-ups using a phone call.
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
Patients with Parkinson's disease who complain of freezing of gait
Behavioral: behavioral intervention based on sensory cues
Patients will receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice.
Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
Time frame: baseline, after 4 weeks
Change from baseline to 4-week f/u in the number of falling
We will ask about the average number of falling over the last week at baseline and at 4-week f/u.
Time frame: baseline, after 4 weeks
Change from baseline to 4-week f/u in FOG-Q total score
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
Time frame: baseline, after 4 weeks
Change from baseline to 2-week f/u in FOG-Q
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
Time frame: baseline, after 2 weeks
Change from baseline to 2-week f/u in the number of falling
We will ask about the average number of falling over the last week at baseline and at 2-week f/u.
Time frame: baseline, after 2 weeks
Change from baseline to 2-week f/u in FOG-Q subscore (Q4+Q5+Q6)
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
Time frame: baseline, after 2 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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