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

Group/Cohort |
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ABI
Acquired brain injury with lower limb spasticity
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Healthy Controls
Age matched healthy controls
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- 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 ]

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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 |
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

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