Validation of an Obstacle Course Used in Patients With Muscle Tightness

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00776048
• Other study ID #: E56806
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 16, 2008
• Last updated: June 23, 2010
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: October 2008
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Controls
• Multiple Sclerosis
• Spasticity
• Stroke
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	KesslerMRREC	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		4 months post acquired brain injury	No