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Validation of an Obstacle Course Used in Patients With Muscle Tightness

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Kessler Foundation.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00776048
First Posted: October 20, 2008
Last Update Posted: June 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kessler Foundation
  Purpose
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
Stroke Traumatic Brain Injury Multiple Sclerosis Spasticity Healthy Controls

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Kessler Foundation:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: January 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
ABI
Acquired brain injury with lower limb spasticity
Healthy Controls
Age matched 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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

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 Submitted: October 16, 2008
First Posted: October 20, 2008
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