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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00308035
Other study ID # 10144
Secondary ID
Status Completed
Phase Phase 1
First received March 24, 2006
Last updated June 12, 2008
Start date November 2005
Est. completion date June 2006

Study information

Verified date June 2008
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

People who have had a stroke often have difficulty walking and problems with their balance. The purpose of this project is to examine problems with foot postures in people who have weakness on one side of their body


Description:

The specific aims of this study are to:

1. Describe foot posture in individuals with hemiplegia following stroke using a quantitative navicular drop test.

2. Determine differences in people with normal, hypotonic, and hypertonic foot posture with regard to ankle range of motion, ankle strength, gait, and balance.

This is an observational design study to describe relationships between the variables. Measurements will include both descriptive and quantitative measures.

Thirty subjects with stroke will participate in one session of testing which will include: clinical assessment of foot posture using a descriptive classification system, quantitative measurement of navicular drop during standing, measurements of ankle range of motion, ankle strength, gait (lower extremity biomechanics and forceplate analysis), and static and dynamic balance. A chi-square test will be used to determine goodness of fit between classification with the descriptive system and the quantitative measurement. Independent one-way ANOVAs will be used to determine the mean differences in the foot posture groups for each of the dependent variables.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- subjects must have a diagnosis of a single stroke with resultant hemiplegia and be able to stand up from a seated position and walk 30 feet without assistance.

Exclusion Criteria:

- Subjects will be excluded if they present with significant foot or ankle pathology, other medical problem that would affect gait or balance, or language / cognitive deficits that would impair ability to give informed consent.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (1)

Lead Sponsor Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

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