Freezing of Gait Correction and Fall Prevention: Developing a Real-time Somatosensory Stimulation System
1 other identifier
interventional
50
1 country
2
Brief Summary
Background and purpose: Freezing of gait (FOG) is one of the most disabling motor symptoms in people with Parkinson's disease (PD), and closely associates with postural instability and fall. Previous studies had shown that somatosensory stimulation could induce weight shift, and this is probably helpful for gait reinitiation. Therefore, the investogators propose a two-year project to develop a wearable device, the somatosensory stimulation system (SSS), which monitors gait real-time and provide somatosensory stimulation once FOG episodes detected. And the investigators test the effects of this SSS device on FOG, fall, and walking function. Methods: The first-year study is to build and validate this wearable SSS device. The customized device has sensor part and stimulator part; the former is an inertial sensor module to detect FOG episodes, and the latter is a microvibrator-embedded insole to facilitate weight shift and gait reinitiation. To validate the device, patients with FOG are recruited and conduct FOG-provoking tasks during their medication "OFF" or "late On" state in a laboratory setting. The investigators test if the SSS device could facilitate lateral weight shift and help gait reinitiation, as well as the reliability. The second-year study is to test if the SSS device stands a long-term, daily wearing basis, and to evaluate its effect on FOG, fall, and walking function. The investigators recruit PD patients with FOG, and randomly assign them into the experimental and control groups. Both groups wear the SSS device during the daytime for ten weeks, and the stimulator part is turned on during the first six weeks (intervention phase) only in the experimental group. The stimulator part is then kept off during the last four weeks (follow-up phase) in both groups. The effect of the SSS device is evaluated by the outcomes including FOG severity, fall and walking function, which are measured prior/after the intervention phase and after the follow-up phase. Clinical relevance: This project tempts to combine real-time gait analysis with somatosensory-induced postural readjustment, and using this novel approach to improve FOG and fall in people with PD. The results of this projects might also provide an objective, long-term assessment tool to measure the FOG phenomenon for clinical and research fields.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2013
CompletedFirst Posted
Study publicly available on registry
January 21, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedOctober 23, 2013
October 1, 2013
1.4 years
January 17, 2013
October 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Reliability of the somatosensory stimulation system
The reliability of the somatosensory stimulation system in detecting freezing-of-gait episodes during gait.
2 weeks
Validity of the somatosensory stimulation system
If the somatosensory stimulation system can facilitate weight shift and help gait reinitiation during freezing-of-gait.
2 weeks
Fall prevention
If the somatosensory stimulation system can reduce the incidence of fall in people with Parkinson disease.
10 weeks
Study Arms (2)
Without real-time somatosensory cue
NO INTERVENTIONParkinson patients wear the somatosensory stimulation system but not receive the real-time somatosensory cue during freezing-of-gait episodes.
With real-time somatosensory cue
EXPERIMENTALParkinson patients wear the somatosensory stimulation system and receive the real-time somatosensory cue during freezing-of-gait episodes.
Interventions
A novel sensory cue proposed in this study, which designed to facilitate weight shift during freezing-of-gait episodes. This sensory cue is controlled by the real-time analysis of gait pattern, and given only when freezing-of-gait detected.
Eligibility Criteria
You may qualify if:
- Idiopathic Parkinsonian with Hoehn-Yahr score between 2 to 4
- Suffering freezing-of-gait in the recent week
- Able to walk unassisted over 30 meters in medication OFF period
You may not qualify if:
- Non-idiopathic Parkinsonian
- Comorbid with uncontrolled neurological, cardiovascular and orthopedic diseases that might affect balance and mobility
- Impaired cognitive function
- Abnormal plantar sensory function
- Abnormal coagulation function
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
National Taiwan University Hospital
Taipei, Taiwan, 100, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruey-Meei Wu, Professor
Department of Neurology, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan
- PRINCIPAL INVESTIGATOR
Kwan-Hwa Lin, Professor
Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ruey-Meei Wu
Study Record Dates
First Submitted
January 17, 2013
First Posted
January 21, 2013
Study Start
February 1, 2013
Primary Completion
July 1, 2014
Last Updated
October 23, 2013
Record last verified: 2013-10