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StrokeNCT00167076

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

An observational study of Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Stroke
How many people
30 participants
Where
1 siteTaiwan
Study dates
Aug 1999to Jul 2002
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University

    Taipei, 100

Other trials in Taiwan

About this study

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.

Read the 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.

Conditions
Stroke
Keywords
Stroke, Foot pressure, Walking speed, Gait
Medical subject headings
Stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2005 (estimated)
  2. Study startAug 1999
  3. Study completionJul 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Defined population
Time perspective
Prospective
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00167076
Sponsor's protocol ID
56m2
Status last verified
Sep 2005
First submitted
12 Sep 2005
Last updated
14 Sep 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2005.

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