Walking Dynamic Among Children With Brain Damge

Cerebral Palsy Clinical Trial

Official title:

The Effect of Changing Walking Conditions on Walking Dynamic Characteristics Among Children Post a Severe Traumatic Brain Injury, Cerebral Palsy and Typically Developed (TD) Control.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02839369
• Other study ID #: 158-08
• Status: Active, not recruiting
• Phase: N/A
• First received: February 28, 2010
• Last updated: July 20, 2016
• Start date: April 2009
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Alyn Pediatric & Adolecent Rehabilitation Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

leisure time physical activity by the Godin and Shephard (G&S) questionnaire. Balance tests - the Timed Up and Go test (TUG) and functional reach test (FRT). Maximal isometric strength was assessed by using a hand held dynamometer; walking dynamics were recorded by an electronic mat, and the 6 minute walk test, energy expenditure index (EEI) and perceived exertion by the OMNI scale.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 13 Years

Eligibility

Inclusion Criteria:

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.

Typically Developed age and sex controls exclusion criteria:

• Children who could not fulfill simple instructions

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Palsy
• Traumatic Brain Injury

Intervention

Other:
• walking under varies conditions
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
• walking under varies conditions
walking on electronic walkway under different conditions

Locations

Country	Name	City	State
Israel	Alyn Children's Rehabilitation Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Alyn Pediatric & Adolecent Rehabilitation Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	step characteristics	The Gaitrite system - step length and time variability (%).	30 minutes	No
Secondary	step time	step time in sec	part of the first assessment	No
Secondary	step length	step length in cm	part of the first assessment	No
Secondary	gait velocity	walking velocity (cm/sec),	part of the first assessment	No