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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01772186
First received: January 17, 2013
Last updated: October 22, 2013
Last verified: October 2013

January 17, 2013
October 22, 2013
February 2013
July 2014   (final data collection date for primary outcome measure)
  • Reliability of the somatosensory stimulation system [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The reliability of the somatosensory stimulation system in detecting freezing-of-gait episodes during gait.
  • Validity of the somatosensory stimulation system [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    If the somatosensory stimulation system can facilitate weight shift and help gait reinitiation during freezing-of-gait.
  • Fall prevention [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    If the somatosensory stimulation system can reduce the incidence of fall in people with Parkinson disease.
Same as current
Complete list of historical versions of study NCT01772186 on ClinicalTrials.gov Archive Site
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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

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Parkinson Disease
Device: 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.
  • No Intervention: 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.
  • Experimental: With real-time somatosensory cue
    Parkinson patients wear the somatosensory stimulation system and receive the real-time somatosensory cue during freezing-of-gait episodes.
    Intervention: Device: Real-time somatosensory cue
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
July 2014   (final data collection date for primary outcome measure)

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
Both
55 Years to 85 Years
No
Contact: Ruey-Meei Wu, Professor 886-2-23123456 ext 2144 robinwu@ntu.edu.tw
Contact: Wen-Chieh Yang, Ph.D. student 886-2-33668149 d98428003@ntu.edu.tw
Taiwan
 
NCT01772186
201112158DIB
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
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
National Taiwan University Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP