NCT02599025

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 6, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

November 4, 2015

Last Update Submit

November 5, 2015

Conditions

Cerebral Palsy

Keywords

Cerebral palsypassive cyclingautonomic control system

Outcome Measures

Primary Outcomes (2)

  • Heart rate variability

    10 minutes each position

  • Blood pressure monitoring

    10 minutes

Study Arms (4)

Supine position

NO INTERVENTION

Children tested while lying down

Standing position

NO INTERVENTION

Children tested while standing

Cycling supine postion

EXPERIMENTAL

Children lying down with APT cycling system

Device: APT cycling system

Cycling standing postion

EXPERIMENTAL

Children standing with Innowalk cycling system

Device: Innowalk cycling system

Interventions

Innowalk cycling systemDEVICE

Innowalk is a unique, motorized medical device

Cycling standing postion
APT cycling systemDEVICE

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

Cycling supine postion

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Motor ability of GMFCS IV-V

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Anthony Luder, MD

    Ziv Medical Center, Zefat

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ranin Hleheil

CONTACT

+97246828710raninhle@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 6, 2015

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Study Completion

August 1, 2017

Last Updated

November 6, 2015

Record last verified: 2015-11