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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02599025
• Other study ID #: ziv-0089015
• Status: Not yet recruiting
• Phase: N/A
• First received: November 4, 2015
• Last updated: November 5, 2015
• Start date: February 2016
• Est. completion date: August 2017

Study information

• Verified date: November 2015
• Source: Ziv Hospital
• Contact: Ranin Hleheil
• Phone: +97246828710
• Email: raninhle[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: August 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 10 Years

Eligibility

Inclusion Criteria:

• Motor ability of GMFCS IV-V

Exclusion Criteria:

• Children with hip subluxation

• On Baclofen inhaler treatment

• Heart disease

• surgical procedures

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Innowalk cycling system
Innowalk is a unique, motorized medical device
• APT cycling system
APT is used as a rehabilitative device that cycles the feet automatically or by the individual

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability		10 minutes each position	No
Primary	Blood pressure monitoring		10 minutes	No