NCT01158027

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
Last Updated

October 18, 2011

Status Verified

October 1, 2011

First QC Date

July 4, 2010

Last Update Submit

October 17, 2011

Conditions

Study Arms (1)

children

Other: gait evaluation

Interventions

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.

children

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Fifteen children post-TBI and fifteen typically control.

You may qualify if:

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

You may not qualify if:

  • had received botulinum toxin for spasticity management or had undergone orthopedic surgery in the past six months.
  • unable to follow simple instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 4, 2010

First Posted

July 8, 2010

Study Start

October 1, 2011

Last Updated

October 18, 2011

Record last verified: 2011-10