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

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Innowalk cycling system
APT cycling system
Sponsored by
Ziv Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cerebral Palsy focused on measuring Cerebral palsy, passive cycling, autonomic control system

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Motor ability of GMFCS IV-V

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    No Intervention

    Experimental

    Experimental

    Arm Label

    Supine position

    Standing position

    Cycling supine postion

    Cycling standing postion

    Arm Description

    Children tested while lying down

    Children tested while standing

    Children lying down with APT cycling system

    Children standing with Innowalk cycling system

    Outcomes

    Primary Outcome Measures

    Heart rate variability
    Blood pressure monitoring

    Secondary Outcome Measures

    Full Information

    First Posted
    November 4, 2015
    Last Updated
    November 5, 2015
    Sponsor
    Ziv Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02599025
    Brief Title
    Effect of Posture and Passive Cycling on Cardiac Autonomic Control System in Children With Severe Cerebral Palsy
    Official Title
    Effect of Posture and Passive Cycling on Cardiac Autonomic Control System in Children With Severe Cerebral Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    February 2017 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ziv Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy
    Keywords
    Cerebral palsy, passive cycling, autonomic control system

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Supine position
    Arm Type
    No Intervention
    Arm Description
    Children tested while lying down
    Arm Title
    Standing position
    Arm Type
    No Intervention
    Arm Description
    Children tested while standing
    Arm Title
    Cycling supine postion
    Arm Type
    Experimental
    Arm Description
    Children lying down with APT cycling system
    Arm Title
    Cycling standing postion
    Arm Type
    Experimental
    Arm Description
    Children standing with Innowalk cycling system
    Intervention Type
    Device
    Intervention Name(s)
    Innowalk cycling system
    Intervention Description
    Innowalk is a unique, motorized medical device
    Intervention Type
    Device
    Intervention Name(s)
    APT cycling system
    Intervention Description
    APT is used as a rehabilitative device that cycles the feet automatically or by the individual
    Primary Outcome Measure Information:
    Title
    Heart rate variability
    Time Frame
    10 minutes each position
    Title
    Blood pressure monitoring
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Motor ability of GMFCS IV-V Exclusion Criteria: Children with hip subluxation On Baclofen inhaler treatment Heart disease surgical procedures
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ranin Hleheil
    Phone
    +97246828710
    Email
    raninhle@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anthony Luder, MD
    Organizational Affiliation
    Ziv Medical Center, Zefat
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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