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

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ClinicalTrials.gov Identifier: NCT01772186
Recruitment Status : Unknown
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 21, 2013
Last Update Posted : October 23, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Parkinson Disease Device: Real-time somatosensory cue

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Freezing of Gait Correction and Fall Prevention in People With Parkinson's Disease: Developing and Application of a Real-time Somatosensory Stimulation System
Study Start Date : February 2013
Estimated Primary Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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.


Outcome Measures

Primary Outcome Measures :
  1. Reliability of the somatosensory stimulation system [ Time Frame: 2 weeks ]
    The reliability of the somatosensory stimulation system in detecting freezing-of-gait episodes during gait.

  2. Validity of the somatosensory stimulation system [ Time Frame: 2 weeks ]
    If the somatosensory stimulation system can facilitate weight shift and help gait reinitiation during freezing-of-gait.

  3. Fall prevention [ Time Frame: 10 weeks ]
    If the somatosensory stimulation system can reduce the incidence of fall in people with Parkinson disease.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772186


Contacts
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

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
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   
Principal Investigator: Ruey-Meei Wu, Professor         
Principal Investigator: Kwan-Hwa Lin, Professor         
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 100
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   
Principal Investigator: Ruey-Meei Wu, Professor         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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
More Information

Responsible Party: National Taiwan University Hospital, Ruey-Meei Wu
ClinicalTrials.gov Identifier: NCT01772186     History of Changes
Other Study ID Numbers: 201112158DIB
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013

Keywords provided by National Taiwan University Hospital:
Freezing of gait
Parkinson's disease
Somatosensory stimulation
Fall prevention

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases