NCT02839369

Brief Summary

The goal of the present study was to look at the effect of changing walking parameters on the dynamic walking characteristics among children post severe traumatic brain injury, children with cerebral palsy and typically developed controls.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2010

Completed
6.4 years until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

7.7 years

First QC Date

February 28, 2010

Last Update Submit

July 20, 2016

Conditions

Traumatic Brain InjuryCerebral Palsy

Keywords

walking performanceCerebral Palsy, Typically Developed

Outcome Measures

Primary Outcomes (1)

  • step characteristics

    The Gaitrite system - step length and time variability (%).

    30 minutes

Secondary Outcomes (3)

  • step time

    part of the first assessment

  • step length

    part of the first assessment

  • gait velocity

    part of the first assessment

Study Arms (1)

children

post Traumatic Brain Injury With Cerebral Palsy Typically developed

Other: walking under varies conditions

Interventions

walking under varies conditionsOTHER

The children were asked to walk an electronic mat, three cycles for each one of the different trials as comfortable regular speed, walking as fast and as slow as possible, walking on straight line etc

children

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children post Traumatic Brain Injury with Cerebral palsy Typically Developed

You may qualify if:

  • Post Traumatic Brain Injury
  • Post severe closed head injury (Glasgow Coma Scale (GCS) score at admission to emergency room of ≤8
  • At least one year post trauma
  • Ages 7 to 13 years
  • Independent ambulation (foot orthoses permitted)
  • Children with Cerebral palsy
  • GMFCS 1 or 2
  • Ages 7 to 13 years
  • Able to stand up from a chair independently and maintain standing for more than 5 seconds without falling, without obvious limitation in the passive range of motion of lower extremities.

You may not qualify if:

  • Children who could not fulfill simple instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alyn Children's Rehabilitation Hospital

Jerusalem, 91090, Israel

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticCerebral Palsy

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBrain Damage, Chronic

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2010

First Posted

July 21, 2016

Study Start

April 1, 2009

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 21, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)