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
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
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
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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