Effect of Posture and Passive Cycling on Cardiac Autonomi... | NCT02599025

Studies
Effect of Posture and Passive Cycling on Cardiac Autonomic Control System in Children With Severe Cerebral Palsy

NCT02599025

Sponsor

Ziv Hospital

Status

Unknown status

Last Update Posted

Nov 6, 2015Estimated

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Cerebral Palsy

Interventions

Innowalk cycling system
APT cycling system

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

Nov 2015

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

Feb 2016

Primary Completion Date

Feb 2017Estimated

Completion Date

Aug 2017Estimated

First Submitted Date

Nov 4, 2015

First Submission Date that Met QC Criteria

Nov 5, 2015

First Posted Date

Nov 6, 2015Estimated

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

Nov 5, 2015

Last Update Posted Date

Nov 6, 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 investigators will examine the immediate contribution of position and movement on the functioning of the autonomic cardiac control system.

Detailed Description

Standing position is a routine therapeutic tool for improving bone density in children with cerebral palsy. The autonomous immediate response for these children is defective. In recent years it has been shown that there is an association between bone density and autonomic function .

In this paper the investigators will examine how the addition of movement to standing subjects contribute to changes in heart rate and blood pressure.

The hypothesis is that the integration of movement while standing presents a change in the autonomic response and thus may improve bone density.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supine position	No Intervention	Children tested while lying down
Standing position	No Intervention	Children tested while standing
Cycling supine postion	Experimental	Children lying down with APT cycling system	Device: APT cycling system
Cycling standing postion	Experimental	Children standing with Innowalk cycling system	Device: Innowalk cycling system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Innowalk cycling system	Device	Innowalk is a unique, motorized medical device	Cycling standing postion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart rate variability		10 minutes each position
Blood pressure monitoring		10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Motor ability of GMFCS IV-V

Exclusion Criteria:

Children with hip subluxation
On Baclofen inhaler treatment
Heart disease
surgical procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ranin Hleheil	Contact	+97246828710		raninhle@gmail.com

Overall Officials

Name	Affiliation	Role
Anthony Luder, MD	Ziv Medical Center, Zefat	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided