NCT02627651

Brief Summary

18 children post acquired brain injury and 18 typically developed controls matched for age and gender. All children aged 10-18 yrs who understand simple commands. Tools:

  1. 1.Heart rate monitor
  2. 2.Six minute walk test
  3. 3.The behavior rating inventory
  4. 4.At the introductory visit the child will be asked to walk for six minutes, to sit and perform a cognitive test and then to walk on a treadmill for 5 seconds.
  5. 5.At the second visit the child will be asked to go on the treadmill for 5 minutes and at the same time to perform the cognitive assignment; After a rest the child will be asked to walk on the treadmill for 5 minutes and at the end to perform the cognitive assignment .

Trial Health

80
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

December 2, 2015

Last Update Submit

July 18, 2016

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (3)

  • Heart rate

    5 min

  • Heart rate variability- time domain measures

    5 min

  • Heart rate variability- frequency domain measures

    5 min

Study Arms (2)

brain injury

EXPERIMENTAL

children post brain injury

Other: cognitive and motor assignments

controls

ACTIVE COMPARATOR

children typically developed age matched

Other: cognitive and motor assignments

Interventions

cognitive and motor assignmentsOTHER

walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .

brain injurycontrols

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • aged 10-18 understand simple commands walk independently

You may not qualify if:

  • Canot understand simple commands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alyn Pediatric and Adolesencent Rehabilitation Center

Jerusalem, 91090, Israel

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 11, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2016

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

IL(1)