Cerebral PalsyNCT02599025
Effect of Posture and Passive Cycling on Cardiac Autonomic Control System in Children With Severe Cerebral Palsy
A study testing Innowalk cycling system and APT cycling system in people with Cerebral Palsy, run by Ziv Hospital.
Trial summary
The investigators will examine the immediate contribution of position and movement on the functioning of the autonomic cardiac control system. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Innowalk cycling system and APT cycling system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Motor ability of GMFCS IV-V
Who cannot join
- Children with hip subluxation
- On Baclofen inhaler treatment
- Heart disease
- surgical procedures
Trial locations and contacts
No sites are listed yet.
About this study
The investigators will examine the immediate contribution of position and movement on the functioning of the autonomic cardiac control system.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Innowalk cycling system, APT cycling system
- Keywords
- Cerebral palsy, passive cycling, autonomic control system
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innowalk cycling systemDevice
Innowalk is a unique, motorized medical device
APT cycling systemDevice
APT is used as a rehabilitative device that cycles the feet automatically or by the individual
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: APT cycling system |
| Cycling standing postion | Experimental | Children standing with Innowalk cycling system Receives: Device: Innowalk cycling system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Measured: 10 minutes each position
Blood pressure monitoring
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anthony Luder, MD, Principal investigator, Ziv Medical Center, Zefat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599025
- Sponsor's protocol ID
- ziv-0089015
- Status last verified
- Nov 2015
- First submitted
- 4 Nov 2015
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Posture and Passive Cycling on Cardiac Autonomic Control System in Children With Severe Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02599025
- Acronym / sponsor ID
- ziv-0089015
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, passive cycling, autonomic control system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 6 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Supine position | No intervention | –Children tested while lying down |
| Standing position | No intervention | –Children tested while standing |
| Cycling supine postion | Experimental | Device: APT cycling systemChildren lying down with APT cycling system |
| Cycling standing postion | Experimental | Device: Innowalk cycling systemChildren standing with Innowalk cycling system |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Motor ability of GMFCS IV-V
Key exclusion criteria (4 listed)
- Children with hip subluxation
- On Baclofen inhaler treatment
- Heart disease
- surgical procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Innowalk cycling systemInnowalk is a unique, motorized medical device | Device | Cycling standing postion |
| APT cycling systemAPT is used as a rehabilitative device that cycles the feet automatically or by the individual | Device | Cycling supine postion |
Primary outcome
Heart rate variability
Time frame: 10 minutes each position
Blood pressure monitoring
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Luder, MD principal investigator
Ziv Medical Center, Zefat
Questions about this trial
What is this clinical trial studying?
A study testing Innowalk cycling system and APT cycling system in people with Cerebral Palsy, run by Ziv Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ranin Hleheil (+97246828710, raninhle@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: 10 minutes each position). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015.