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Clinical Applications and Evaluations of A Portable In-Shoe Plantar Pressure Monitoring and Biofeedback Gait System for Ambulation Training in Stroke Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00167076
Recruitment Status : Unknown
Verified September 2005 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital

Brief Summary:
The purposes of this paper were to determine whether walking speed affected gait parameters and force impulse in patients with stroke or not, and if the changes varied in various foot regions.

Condition or disease

Detailed Description:
Stroke patients often suffer from persistent physical, psychological, and motor dysfunction, which severely affect their independence in daily life. Therefore, restoration of independent ambulatory ability is one of the most important goals in stroke rehabilitation. To achieve such a goal, ambulation aids are important and necessary devices to assist their ambulatory ability or ambulation training. Whereas the use of ambulation assistive devices promotes early mobility and facilitates early restoration of function for these patients, improper or prolonged use of these devices may inevitably cause negative training effects, such as patients may become over-dependent upon the assistance offered by these devices. The formation of such dependence would hinder the progress of stroke patients to achieve the ultimate goal of independent walking without any assistive devices. To assess the influences of using ambulation assistive devices, it is therefore imperative that clinicians closely and subjectively evaluate the gait pattern and force production pattern of patients when they walk with ambulation aids. In addition, ambulation assistive devices equipped with device pressure feedback function can be used not only to assist in ambulating but also to monitor patient's level of dependence on devices. The device pressure feedback information can be used to train patients to gradually reduce their dependence on devices. To date, due to the limitations of conventional laboratory methods of gait analysis, the "multi-footed" gait patterns presented by stroke patients, when they are walking with ambulation aids, have not yet been studied with biomechanical analysis. Moreover, whether the use of ambulation assistive devices equipped with feedback function can effectively improve stroke patients' gait patterns or their ability to achieve independent walking remains unknown. Answers to both questions would provide important knowledge for clinicians to base upon in evaluating weight bearing symmetry between the two lower extremities in stroke patients and the training effects of using ambulation aids for these patients.

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Study Type : Observational
Enrollment : 30 participants
Observational Model: Defined Population
Time Perspective: Prospective
Official Title: Clinical Applications and Evaluations of A Portable In-Shoe Plantar Pressure Monitoring and Biofeedback Gait System for Ambulation Training in Stroke Rehabilitation
Study Start Date : August 1999
Study Completion Date : July 2002

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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • between 40 and 75 years old
  • stroke confirmed by ICD-10-CM (including I60, I61, I62, I63, I67, and I63.9)
  • first stroke with single side hemiplegia and received acute treatment at NTUH
  • being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
  • able to ambulate independently and continuously for 10 meters with regular cane

Excursion criteria:

  • having unstable vital sign, unconsciousness, or obvious cognitive, perception, and language impairment, and couldn't communicate with the experimenters
  • having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal or cardiovascular disorders, or disorders from systematic diseases other than stroke

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 identifier (NCT number): NCT00167076

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School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
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Principal Investigator: Pei-Fang Tang, PhD National Taiwan University Hospital
Layout table for additonal information Identifier: NCT00167076    
Other Study ID Numbers: 56m2
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 14, 2005
Last Verified: September 2005
Keywords provided by National Taiwan University Hospital:
Foot pressure
Walking speed
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases