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Validation of an Obstacle Course Used in Patients With Muscle Tightness

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ClinicalTrials.gov Identifier: NCT00776048
Recruitment Status : Unknown
Verified October 2008 by Kessler Foundation.
Recruitment status was:  Enrolling by invitation
First Posted : October 20, 2008
Last Update Posted : June 24, 2010
Sponsor:
Information provided by:
Kessler Foundation

Study Description
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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.

Condition or disease
Stroke Traumatic Brain Injury Multiple Sclerosis Spasticity Healthy Controls

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Validation of a New Method to Evaluate the Effects of Chemoneurolytic Intervention on Balance and Community Ambulation in Spastic Hemiplegic Patients
Study Start Date : January 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

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Groups and Cohorts
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Group/Cohort
ABI
Acquired brain injury with lower limb spasticity
Healthy Controls
Age matched healthy controls


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects ages > 18 years of age for this study. A total of up to 10 age matched controls and 30 clinical patients with lower extremity spasticity will be enrolled. Of the 30 clinical patients, 20 clinical patients will have received BOTOX ® injections from their clinical physician after their first visit.
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
Contacts and Locations
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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): NCT00776048


Locations
United States, New Jersey
KesslerMRREC
West Orange, New Jersey, United States, 07052
Sponsors and Collaborators
Kessler Foundation
Investigators
Principal Investigator: Elie P Elovic, M.D. Kessler Foundation
More Information
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Responsible Party: Elie Elovic, M.D., Kessler Medical Rehabilitation Research and Education Center
ClinicalTrials.gov Identifier: NCT00776048     History of Changes
Other Study ID Numbers: E56806
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: June 24, 2010
Last Verified: October 2008

Additional relevant MeSH terms:
Multiple Sclerosis
Brain Injuries
Brain Injuries, Traumatic
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries