Validity and Reliability of Perceived Exertion Rating Sca... | NCT01840644

Studies
Validity and Reliability of Perceived Exertion Rating Scale in Children With Brain Damage

NCT01840644

Sponsor

Alyn Pediatric & Adolescent Rehabilitation Hospital

Status

Completed

Last Update Posted

Jun 23, 2015Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Traumatic Brain Injury
Cerebral Palsy

Interventions

Walking on treadmill, different velocities and incline

Countries

Israel

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Feb 15, 2010

First Submission Date that Met QC Criteria

Apr 23, 2013

First Posted Date

Apr 26, 2013Estimated

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

Jun 22, 2015

Last Update Posted Date

Jun 23, 2015Estimated

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 purpose of this study is to examine the reliability and validity of the rating of perceived exertion scale in children post severe traumatic brain injury during treadmill exercise.

Detailed Description

walking on a treadmill twice- one weeks interval five intensity level in each session

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
all participants		Walking on treadmill, different velocities and incline	Other: Walking on treadmill, different velocities and incline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Walking on treadmill, different velocities and incline	Other	Walking on treadmill twice, with one week interval in each session the child will walk in different velocities and incline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OMNI scale, a pictorial perceived extortion scale for children		three meetings once a week.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children 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 12 years
(3) independent ambulation (foot orthoses permitted).
Children with Cerebral palsy, GMFCS 1 or 2, ages 7 to 12 years. Typically developed controls.

Exclusion criteria:

Cannot understand simple instructions

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Children post severe TBI Children with CP TD control

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michal Katz, Phd	Alyn rehabilitation center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alyn Children's Rehabilitation Hospital		Jerusalem		91090	Israel

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided