Brain InjuryNCT00746291
Heart Rate Variability (HRV) Among Children With Brain Damage
A study testing 6 min walk test, Step climbing in people with Brain Injury and Cerebral Palsy, run by Alyn Pediatric & Adolescent Rehabilitation Hospital at 1 site in Israel.
Trial summary
to investigate the function of the autonomic nervous system in children with with post traumatic brain injury and children with cerebral palsy through an analysis of heart rate variability (HRV) occurring with walking performance. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injury, Cerebral Palsy
- What is being tested?
- 6 min walk test, Step climbing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2008to Jun 2009
- 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 12 years
- Healthy volunteers accepted
- Child
Who may be able to join
- able to walk independently
Who cannot join
- can not follow simple commands
Trial locations and contacts
1 site in 1 country.
Israel1 site
Alyn Pediatric and Adolescent Rehabilitation Center
Jerusalem, 91090
About this study
Official title: Assessment of Autonomic Nervous System With Analysis of Heart Rate Variability in Children With Brain Damage.
to investigate the function of the autonomic nervous system in children with with post traumatic brain injury and children with cerebral palsy through an analysis of heart rate variability (HRV) occurring with walking performance.
Read the detailed description
40 children with brain damage (20 with post TBI and 20 with CP)and 40 typically developed children will be participate in this study. ECG signals during rest and walking (for 6 minute and during step climbing) will be recorded.
- Conditions
- Brain Injury, Cerebral Palsy
- Being tested
- 6 min walk test, Step climbing
- Medical subject headings
- Brain Injuries, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 min walk test, Step climbingOther
walking for 6 minute and climbing steps
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Traumatic brain injury Receives: Other: 6 min walk test, Step climbing |
| B | Experimental | Cerebral palsy Receives: Other: 6 min walk test, Step climbing |
| C | Experimental | Controls Receives: Other: 6 min walk test, Step climbing |
What is being measured
The primary outcome is the main question the study is designed to answer.
HRV parameters
Measured: during the assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hemda Rotem, Principal investigator, Alyn Hopspital Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746291
- Sponsor's protocol ID
- alyn3CTIL
- Status last verified
- Jul 2012
- First submitted
- 1 Sep 2008
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Autonomic Nervous System With Analysis of Heart Rate Variability in Children With Brain Damage.
- ClinicalTrials.gov ID
- NCT00746291
- Acronym / sponsor ID
- alyn3CTIL
- Conditions
- Brain Injury, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Sep 2008 (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.
to investigate the function of the autonomic nervous system in children with with post traumatic brain injury and children with cerebral palsy through an analysis of heart rate variability (HRV) occurring with walking performance.
Detailed description
40 children with brain damage (20 with post TBI and 20 with CP)and 40 typically developed children will be participate in this study. ECG signals during rest and walking (for 6 minute and during step climbing) will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: 6 min walk test, Step climbingTraumatic brain injury |
| B | Experimental | Other: 6 min walk test, Step climbingCerebral palsy |
| C | Experimental | Other: 6 min walk test, Step climbingControls |
Who may qualify
- Ages
- 6 to 12 years
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- able to walk independently
Key exclusion criteria (1 listed)
- can not follow simple commands
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 |
|---|---|---|
| 6 min walk test, Step climbingwalking for 6 minute and climbing steps | Other | A, B, C |
Primary outcome
HRV parameters
Time frame: during the assessment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
Related trials for Brain Injury
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
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.
Hemda Rotem principal investigator
Alyn Hopspital Jerusalem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 min walk test, Step climbing in people with Brain Injury and Cerebral Palsy, run by Alyn Pediatric & Adolescent Rehabilitation Hospital 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 10 Jul 2012. 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 was stopped early. Results are not available in the source record.
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?
HRV parameters (time frame: during the assessment). 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 10 Jul 2012.