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Freezing of Gait Correction and Fall Prevention: Developing a Real-time Somatosensory Stimulation System

Freezing of Gait Correction and Fall Prevention in People With Parkinson's Disease: Developing and Application of a Real-time Somatosensory Stimulation System

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01772186
Enrollment
50
Registered
2013-01-21
Start date
2013-02-28
Completion date
Unknown
Last updated
2013-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Freezing of gait, Parkinson's disease, Somatosensory stimulation, Fall prevention

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.

Interventions

DEVICEReal-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.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Reliability of the somatosensory stimulation system2 weeksThe reliability of the somatosensory stimulation system in detecting freezing-of-gait episodes during gait.
Validity of the somatosensory stimulation system2 weeksIf the somatosensory stimulation system can facilitate weight shift and help gait reinitiation during freezing-of-gait.
Fall prevention10 weeksIf the somatosensory stimulation system can reduce the incidence of fall in people with Parkinson disease.

Countries

Taiwan

Contacts

Primary ContactRuey-Meei Wu, Professor
robinwu@ntu.edu.tw886-2-23123456
Backup ContactWen-Chieh Yang, Ph.D. student
d98428003@ntu.edu.tw886-2-33668149

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026