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

NCT ID: NCT02599025

Last Updated: 2015-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Supine position

Children tested while lying down

Group Type NO_INTERVENTION

No interventions assigned to this group

Standing position

Children tested while standing

Group Type NO_INTERVENTION

No interventions assigned to this group

Cycling supine postion

Children lying down with APT cycling system

Group Type EXPERIMENTAL

APT cycling system

Intervention Type DEVICE

APT is used as a rehabilitative device that cycles the feet automatically or by the individual

Cycling standing postion

Children standing with Innowalk cycling system

Group Type EXPERIMENTAL

Innowalk cycling system

Intervention Type DEVICE

Innowalk is a unique, motorized medical device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Innowalk cycling system

Innowalk is a unique, motorized medical device

Intervention Type DEVICE

APT cycling system

APT is used as a rehabilitative device that cycles the feet automatically or by the individual

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Motor ability of GMFCS IV-V

Exclusion Criteria

* Children with hip subluxation
* On Baclofen inhaler treatment
* Heart disease
* surgical procedures
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ziv Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anthony Luder, MD

Role: PRINCIPAL_INVESTIGATOR

Ziv Medical Center, Zefat

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ranin Hleheil

Role: CONTACT

+97246828710

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ziv-0089015

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.