- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02599025
Effect of Posture and Passive Cycling on Cardiac Autonomic Control System in Children With Severe Cerebral Palsy
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ranin Hleheil
- Phone Number: +97246828710
- Email: raninhle@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
|
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
Sponsor
Investigators
- Principal Investigator: Anthony Luder, MD, Ziv Medical Center, Zefat
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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