Validation of an Obstacle Course Used in Patients With Muscle Tightness

NCT ID: NCT00776048

Last Updated: 2010-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke Traumatic Brain Injury Multiple Sclerosis Spasticity Healthy Controls

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ABI

Acquired brain injury with lower limb spasticity

No interventions assigned to this group

Healthy Controls

Age matched healthy controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Kessler Medical Rehabilitation Research and Education Center

Principal Investigators

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Elie P Elovic, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

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KesslerMRREC

West Orange, New Jersey, United States

Site Status

Countries

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United States

Related Links

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https://kesslerfoundation.org/research/nnjtbis/

KesslerMRREC Traumatic Brain Injury Website

Other Identifiers

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E56806

Identifier Type: -

Identifier Source: org_study_id

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