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Evaluating Walking Kinetic of Children Who Suffer Central Nervous System (CNS) Damage

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 2011 by Dr. Ofer Keren, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01158027
First Posted: July 8, 2010
Last Update Posted: October 18, 2011
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 (Responsible Party):
Dr. Ofer Keren, Sheba Medical Center
  Purpose
The goal of the present study is to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, and typically developed controls.

Condition Intervention
Walking Performance Other: gait evaluation

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Evaluating Walking Kinetic of Children Who Suffer Central Nervous System (CNS)

Further study details as provided by Dr. Ofer Keren, Sheba Medical Center:

Estimated Enrollment: 30
Study Start Date: October 2011
Groups/Cohorts Assigned Interventions
children Other: gait evaluation
The children will asked to walk under different conditions: (1) walking at a self-selected speed faster and slower on the GAITRite® system and on a treadmill and while listening and to a metronomeQuoting.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Fifteen children post-TBI and fifteen typically control.
Criteria

Inclusion Criteria:

  1. post-severe closed head injury (Glasgow Coma Scale [GCS] score at admission to emergency room of ≤8) [Kathryn 2008].
  2. at least one year post trauma.
  3. ages 7 to 13 years.
  4. independent ambulation (foot orthoses permitted).

Exclusion Criteria:

  1. had received botulinum toxin for spasticity management or had undergone orthopedic surgery in the past six months.
  2. unable to follow simple instructions.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dr. Ofer Keren, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01158027     History of Changes
Other Study ID Numbers: SHEBA-10-7999-OK-CTIL
First Submitted: July 4, 2010
First Posted: July 8, 2010
Last Update Posted: October 18, 2011
Last Verified: October 2011