Evaluating Walking Kinetic of Children Who Suffer Central... | NCT01158027

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

NCT01158027

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Oct 18, 2011Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Walking Performance

Interventions

gait evaluation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 4, 2010

First Submission Date that Met QC Criteria

Jul 7, 2010

First Posted Date

Jul 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2011

Last Update Posted Date

Oct 18, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
children			Other: gait evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gait evaluation	Other	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 Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Fifteen children post-TBI and fifteen typically control.

Sampling Method

Non-Probability Sample