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Clinical Trials/NCT00776048
NCT00776048
Unknown
Not Applicable

The Validation of a New Method to Evaluate the Effects of Chemoneurolytic Intervention on Balance and Community Ambulation in Spastic Hemiplegic Patients

Kessler Foundation1 site in 1 country40 target enrollmentJanuary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Kessler Foundation
Enrollment
40
Locations
1
Primary Endpoint
To demonstrate the objective utility of the use of pedobarography to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ADA based obstacle course.
Last Updated
15 years ago

Overview

Brief Summary

This study is being conducted to compare healthy patients versus patients with muscle tightness in their leg(s) after an acquired brain injury using walking trials time, a balance test, and foot pressure data. This data is obtained using foot pressure sensors, timers, and distance walked.

Detailed Description

This study is being conducted to demonstrate the objective utility of the use of pedobarography as a tool to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ADA based obstacle course.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
December 2009
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Kessler Foundation

Eligibility Criteria

Inclusion Criteria

  • Patients \> 18 years of age
  • Must wear shoe size 5½ - 11 US womens or size 6 - 13 US mens
  • For treatment group be a clinical patient being treated for lower extremity spasticity

Exclusion Criteria

  • Age matched controls must have no significant neurological or orthopedic disease that would effect their gait
  • Clinical patients who are unable to walk for 1 minute

Outcomes

Primary Outcomes

To demonstrate the objective utility of the use of pedobarography to differentiate normal controls from people with spastic gait as well as having utility in objectification of treatment effect on level surfaces and on a ADA based obstacle course.

Time Frame: 4 months post acquired brain injury

Study Sites (1)

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