Cerebral PalsyNCT01872507
BioFeedBack Breathing Training Influence Cardiac Autonomic Nervous System in Children With Cerebral-Palsy.
A study testing Biofeedback training in people with Cerebral Palsy and Autonomic Nerveus System, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The effect of breathing biofeedback training to influence the function of the cardiac autonomic nervous system at rest and in activity in children with cerebral palsy. Cerebral palsy children suffer from a non-progressive damage of the brain. It is the most common injury that causes physical handicapped in childhood. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Cerebral Palsy, Autonomic Nerveus System
- What is being tested?
- Biofeedback training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Jan 2016
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with cerebral palsy
- age 6-11 years
- able to walk
- both gender
Who cannot join
- heart or lung known disease
- can not follow simple commends
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breathing Biofeedback Training to Influence the Function of the Cardiac Autonomic Nervous System at Rest and in Activity in Children With Cerebral Palsy.
The effect of breathing biofeedback training to influence the function of the cardiac autonomic nervous system at rest and in activity in children with cerebral palsy.
Cerebral palsy children suffer from a non-progressive damage of the brain. It is the most common injury that causes physical handicapped in childhood. There are a few researches that investigated the autonomic function in cerebral palsy children. Those researches found hyperactivity of the sympathetic autonomic system, including high resting heart rate compare to their typically developed pears. The recommended treatment for cerebral palsy is activity, muscle strengthening and mobility. The impairment in the autonomic system influences the everyday function and has correlation with secondary morbidity.
Read more
As far as we know there are no researches who investigated the following issues.
In this study we would like to:
- Describe the autonomic cardiac function, Breathing function, motor function and the correlation between them in children with cerebral palsy.
- Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic breathing.
- Test the influence of breathing training on Heart rate variability parameters at rest, in aerobic test right after the breathing training program and one month after, in children with cerebral palsy
Read the detailed description
Participants:
60 children with cerebral palsy age 6-11 who can walk and understand simple instructions.
Main outcome measures:
Heart rate variability using Polar watch and transmitter RS810CX.
Secondary outcome measures:
- Lung functioning using Sensormedics Vmax 29 spirometry:Forced Vital Capacity, Forced Expiratory Volume in one,Tidal Volume.
- Biofeedback
- Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter.
- Gross Motor Function Classification System
- Gross Motor Function Measure
- Functional Mobility Scale
- Children Assessment of Participation and Enjoyment
- Autonomic function questionnaire
- Conditions
- Cerebral Palsy, Autonomic Nerveus System
- Being tested
- Biofeedback training
- Keywords
- cerebral palsy, autonomic nerveus system, heart rate variability
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback trainingOther
usual treatment +12 biofeedback training
| Study group | Role | What they receive |
|---|---|---|
| biofeedback training | Active comparator | usual treatment+12 treatment of biofeedback training Receives: Other: Biofeedback training |
| control | No intervention | usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of Heart rate variability meaures at one and two months
Measured: Change from Baseline at one and two months
Secondary outcomes (3)
Change from Baseline of Forced Vital Capacity, Forced Expiratory Volume in one, Tidal Volume,
Measured: Change from Baseline at one and two month
Change from Baseline Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter.
Measured: Change from baseline at one and two month later
Change from baseline breathing rate, by biofeedback
Measured: Change from baseline at one and two month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BERGER ITAI, Hadassah Medical Organization
- Investigators
- Itai Berger, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872507
- Sponsor's protocol ID
- HMO-0374-12
- Status last verified
- Feb 2018
- First submitted
- 1 May 2013
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zamuner AR, Cunha AB, da Silva E, Negri AP, Tudella E, Moreno MA. The influence of motor impairment on autonomic heart rate modulation among children with cerebral palsy. Res Dev Disabil. 2011 Jan-Feb;32(1):217-21. doi: 10.1016/j.ridd.2010.09.020. Epub 2010 Oct 16.
PubMed 20956067Sutarto AP, Wahab M, Zin NM. Heart Rate Variability (HRV),biofeedback; A new training approch for aperator's performance enhancement. JIEM, 2010, 3;176-198.
Ferreira MC, Pastore C, Imada R, Guare R, Leite M, Poyares D, Santos MT. Autonomic nervous system in individuals with cerebral palsy: a controlled study. J Oral Pathol Med. 2011 Aug;40(7):576-81. doi: 10.1111/j.1600-0714.2011.01008.x. Epub 2011 Feb 16.
PubMed 21323740Lehrer PM, Vaschillo E, Vaschillo B. Resonant frequency biofeedback training to increase cardiac variability: rationale and manual for training. Appl Psychophysiol Biofeedback. 2000 Sep;25(3):177-91. doi: 10.1023/a:1009554825745.
PubMed 10999236
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Biofeedback Training to Influence the Function of the Cardiac Autonomic Nervous System at Rest and in Activity in Children With Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT01872507
- Acronym / sponsor ID
- HMO-0374-12
- Conditions
- Cerebral Palsy, Autonomic Nerveus System
- Keywords
- cerebral palsy, autonomic nerveus system, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 7 Jun 2013 (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 effect of breathing biofeedback training to influence the function of the cardiac autonomic nervous system at rest and in activity in children with cerebral palsy.
Cerebral palsy children suffer from a non-progressive damage of the brain. It is the most common injury that causes physical handicapped in childhood. There are a few researches that investigated the autonomic function in cerebral palsy children. Those researches found hyperactivity of the sympathetic autonomic system, including high resting heart rate compare to their typically developed pears. The recommended treatment for cerebral palsy is activity, muscle strengthening and mobility. The impairment in the autonomic system influences the everyday function and has correlation with secondary morbidity.
As far as we know there are no researches who investigated the following issues.
In this study we would like to:
- Describe the autonomic cardiac function, Breathing function, motor function and the correlation between them in children with cerebral palsy.
- Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic breathing.
- Test the influence of breathing training on Heart rate variability parameters at rest, in aerobic test right after the breathing training program and one month after, in children with cerebral palsy
Detailed description
Participants:
60 children with cerebral palsy age 6-11 who can walk and understand simple instructions.
Main outcome measures:
Heart rate variability using Polar watch and transmitter RS810CX.
Secondary outcome measures:
- Lung functioning using Sensormedics Vmax 29 spirometry:Forced Vital Capacity, Forced Expiratory Volume in one,Tidal Volume.
- Biofeedback
- Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter.
- Gross Motor Function Classification System
- Gross Motor Function Measure
- Functional Mobility Scale
- Children Assessment of Participation and Enjoyment
- Autonomic function questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biofeedback training | Active comparator | Other: Biofeedback trainingusual treatment+12 treatment of biofeedback training |
| control | No intervention | –usual treatment |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children with cerebral palsy
- age 6-11 years
- able to walk
- both gender
Key exclusion criteria (2 listed)
- heart or lung known disease
- can not follow simple commends
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 |
|---|---|---|
| Biofeedback trainingusual treatment +12 biofeedback training | Other | biofeedback training |
Primary outcome
Change from Baseline of Heart rate variability meaures at one and two months
Time frame: Change from Baseline at one and two months
3 secondary outcomes
Change from Baseline of Forced Vital Capacity, Forced Expiratory Volume in one, Tidal Volume,
Time frame: Change from Baseline at one and two month
Change from Baseline Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter.
Time frame: Change from baseline at one and two month later
Change from baseline breathing rate, by biofeedback
Time frame: Change from baseline at one and two month later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Background: PubMed 20956067Zamuner AR, Cunha AB, da Silva E, Negri AP, Tudella E, Moreno MA. The influence of motor impairment on autonomic heart rate modulation among children with cerebral palsy. Res Dev Disabil. 2011 Jan-Feb;32(1):217-21. doi: 10.1016/j.ridd.2010.09.020. Epub 2010 Oct 16.
- BackgroundSutarto AP, Wahab M, Zin NM. Heart Rate Variability (HRV),biofeedback; A new training approch for aperator's performance enhancement. JIEM, 2010, 3;176-198.
- Background: PubMed 21323740Ferreira MC, Pastore C, Imada R, Guare R, Leite M, Poyares D, Santos MT. Autonomic nervous system in individuals with cerebral palsy: a controlled study. J Oral Pathol Med. 2011 Aug;40(7):576-81. doi: 10.1111/j.1600-0714.2011.01008.x. Epub 2011 Feb 16.
- Background: PubMed 10999236Lehrer PM, Vaschillo E, Vaschillo B. Resonant frequency biofeedback training to increase cardiac variability: rationale and manual for training. Appl Psychophysiol Biofeedback. 2000 Sep;25(3):177-91. doi: 10.1023/a:1009554825745.
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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.
Itai Berger, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback training in people with Cerebral Palsy and Autonomic Nerveus System, run by Hadassah Medical Organization at 1 site in Israel.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of Heart rate variability meaures at one and two months (time frame: Change from Baseline at one and two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01872507, which also lists 4 linked publications.
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 28 Feb 2018.