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

November 5, 2015 updated by: Ziv Hospital
The investigators will examine the immediate contribution of position and movement on the functioning of the autonomic cardiac control system.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Motor ability of GMFCS IV-V

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Supine position
Children tested while lying down
No Intervention: Standing position
Children tested while standing
Experimental: Cycling supine postion
Children lying down with APT cycling system
Device: APT cycling system
APT is used as a rehabilitative device that cycles the feet automatically or by the individual
Experimental: Cycling standing postion
Children standing with Innowalk cycling system
Device: Innowalk cycling system
Innowalk is a unique, motorized medical device

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Investigators

  • Principal Investigator: Anthony Luder, MD, Ziv Medical Center, Zefat

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Estimate)

November 6, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ziv-0089015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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