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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Real-time somatosensory cue
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Freezing of gait, Parkinson's disease, Somatosensory stimulation, Fall prevention

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Without real-time somatosensory cue

With real-time somatosensory cue

Arm Description

Parkinson patients wear the somatosensory stimulation system but not receive the real-time somatosensory cue during freezing-of-gait episodes.

Parkinson patients wear the somatosensory stimulation system and receive the real-time somatosensory cue during freezing-of-gait episodes.

Outcomes

Primary Outcome Measures

Reliability of the somatosensory stimulation system
The reliability of the somatosensory stimulation system in detecting freezing-of-gait episodes during gait.
Validity of the somatosensory stimulation system
If the somatosensory stimulation system can facilitate weight shift and help gait reinitiation during freezing-of-gait.
Fall prevention
If the somatosensory stimulation system can reduce the incidence of fall in people with Parkinson disease.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2013
Last Updated
October 22, 2013
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01772186
Brief Title
Freezing of Gait Correction and Fall Prevention: Developing a Real-time Somatosensory Stimulation System
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 Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Freezing of gait, Parkinson's disease, Somatosensory stimulation, Fall prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Without real-time somatosensory cue
Arm Type
No Intervention
Arm Description
Parkinson patients wear the somatosensory stimulation system but not receive the real-time somatosensory cue during freezing-of-gait episodes.
Arm Title
With real-time somatosensory cue
Arm Type
Experimental
Arm Description
Parkinson patients wear the somatosensory stimulation system and receive the real-time somatosensory cue during freezing-of-gait episodes.
Intervention Type
Device
Intervention Name(s)
Real-time somatosensory cue
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reliability of the somatosensory stimulation system
Description
The reliability of the somatosensory stimulation system in detecting freezing-of-gait episodes during gait.
Time Frame
2 weeks
Title
Validity of the somatosensory stimulation system
Description
If the somatosensory stimulation system can facilitate weight shift and help gait reinitiation during freezing-of-gait.
Time Frame
2 weeks
Title
Fall prevention
Description
If the somatosensory stimulation system can reduce the incidence of fall in people with Parkinson disease.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruey-Meei Wu, Professor
Phone
886-2-23123456
Ext
2144
Email
robinwu@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Chieh Yang, Ph.D. student
Phone
886-2-33668149
Email
d98428003@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruey-Meei Wu, Professor
Organizational Affiliation
Department of Neurology, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kwan-Hwa Lin, Professor
Organizational Affiliation
Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruey-Meei Wu, Professor
Phone
886-2-23123456
Ext
2144
Email
robinwu@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Wen-Chieh Yang, Ph.D. student
Phone
886-2-33668149
Email
d98428003@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Ruey-Meei Wu, Professor
First Name & Middle Initial & Last Name & Degree
Kwan-Hwa Lin, Professor
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruey-Meei Wu, Professor
Phone
886-2-23123456
Ext
2144
Email
robinwu@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Wen-Chieh Yang, Ph.D. student
Phone
886-2-33668149
Email
d98428003@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Ruey-Meei Wu, Professor

12. IPD Sharing Statement

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

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