Validation of an Obstacle Course Used in Patients With Muscle Tightness

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Multiple Sclerosis; Traumatic Brain Injury; 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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • KesslerMRREC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Investigators: Principal Investigator: Elie P Elovic, M.D., Kessler Foundation

Publications and helpful links

Helpful Links

• KesslerMRREC Traumatic Brain Injury Website

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Anticipated): December 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: October 16, 2008
• First Submitted That Met QC Criteria: October 17, 2008
• First Posted (Estimate): October 20, 2008

Study Record Updates

• Last Update Posted (Estimate): June 24, 2010
• Last Update Submitted That Met QC Criteria: June 23, 2010
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Multiple Sclerosis; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: E56806