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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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by National Taiwan University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00167076
First Posted: September 14, 2005
Last Update Posted: December 9, 2005
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.
Collaborator:
National Science Council, Taiwan
Information provided by:
National Taiwan University Hospital
  Purpose
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
Stroke

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 30
Study Start Date: August 1999
Estimated Study Completion Date: July 2002
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.
  Eligibility

Information from the National Library of Medicine

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

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
  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): NCT00167076


Locations
Taiwan
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
Investigators
Principal Investigator: Pei-Fang Tang, PhD National Taiwan University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00167076     History of Changes
Other Study ID Numbers: 56m2
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Keywords provided by National Taiwan University Hospital:
Stroke
Foot pressure
Walking speed
Gait

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases