Freezing of Gait Correction and Fall Prevention: Developing a Real-time Somatosensory Stimulation System
NCT ID: NCT01772186
Last Updated: 2013-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2013-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Without real-time somatosensory cue
Parkinson patients wear the somatosensory stimulation system but not receive the real-time somatosensory cue during freezing-of-gait episodes.
No interventions assigned to this group
With real-time somatosensory cue
Parkinson patients wear the somatosensory stimulation system and receive the real-time somatosensory cue during freezing-of-gait episodes.
Real-time somatosensory cue
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Real-time somatosensory cue
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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Suffering freezing-of-gait in the recent week
* Able to walk unassisted over 30 meters in medication OFF period
Exclusion Criteria
* Comorbid with uncontrolled neurological, cardiovascular and orthopedic diseases that might affect balance and mobility
* Impaired cognitive function
* Abnormal plantar sensory function
* Abnormal coagulation function
55 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Taiwan University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
National Taiwan University Hospital
Ruey-Meei Wu
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ruey-Meei Wu, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan
Kwan-Hwa Lin, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ruey-Meei Wu, Professor
Role: primary
Wen-Chieh Yang, Ph.D. student
Role: backup
Ruey-Meei Wu, Professor
Role: primary
Wen-Chieh Yang, Ph.D. student
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201112158DIB
Identifier Type: -
Identifier Source: org_study_id