Brain InjuriesNCT02627651
The Cardiac Autonomic System Response to Activity and Cognitive Tasksinjury
A study testing cognitive and motor assignments in people with Brain Injuries, run by Alyn Pediatric & Adolescent Rehabilitation Hospital at 1 site in Israel.
Trial summary
18 children post acquired brain injury and 18 typically developed controls matched for age and gender. All children aged 10-18 yrs who understand simple commands. Tools: 1. Heart rate monitor 2. Six minute walk test 3. The behavior rating inventory Method: 1. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries
- What is being tested?
- cognitive and motor assignments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Jul 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- aged 10-18 understand simple commands walk independently
Who cannot join
- Canot understand simple commands
Trial locations and contacts
1 site in 1 country.
Israel1 site
Alyn Pediatric and Adolesencent Rehabilitation Center
Jerusalem, 91090
About this study
Official title: The Cardiac Autonomic System Response to Activity and Cognitive Tasks in Children Post Acquired Brain
18 children post acquired brain injury and 18 typically developed controls matched for age and gender.
All children aged 10-18 yrs who understand simple commands.
Tools:
- Heart rate monitor
- Six minute walk test
- The behavior rating inventory
Method:
- At the introductory visit the child will be asked to walk for six minutes, to sit and perform a cognitive test and then to walk on a treadmill for 5 seconds.
- At the second visit the child will be asked to go on the treadmill for 5 minutes and at the same time to perform the cognitive assignment; After a rest the child will be asked to walk on the treadmill for 5 minutes and at the end to perform the cognitive assignment .
- Conditions
- Brain Injuries
- Being tested
- cognitive and motor assignments
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive and motor assignmentsOther
walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .
| Study group | Role | What they receive |
|---|---|---|
| brain injury | Experimental | children post brain injury Receives: Other: cognitive and motor assignments |
| controls | Active comparator | children typically developed age matched Receives: Other: cognitive and motor assignments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Measured: 5 min
Heart rate variability- time domain measures
Measured: 5 min
Heart rate variability- frequency domain measures
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627651
- Sponsor's protocol ID
- Alyn
- Status last verified
- Jul 2016
- First submitted
- 2 Dec 2015
- Last updated
- 19 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardiac Autonomic System Response to Activity and Cognitive Tasks in Children Post Acquired Brain
- ClinicalTrials.gov ID
- NCT02627651
- Acronym / sponsor ID
- Alyn
- Conditions
- Brain Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- First posted
- 11 Dec 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.
18 children post acquired brain injury and 18 typically developed controls matched for age and gender.
All children aged 10-18 yrs who understand simple commands.
Tools:
- Heart rate monitor
- Six minute walk test
- The behavior rating inventory
Method:
- At the introductory visit the child will be asked to walk for six minutes, to sit and perform a cognitive test and then to walk on a treadmill for 5 seconds.
- At the second visit the child will be asked to go on the treadmill for 5 minutes and at the same time to perform the cognitive assignment; After a rest the child will be asked to walk on the treadmill for 5 minutes and at the end to perform the cognitive assignment .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brain injury | Experimental | Other: cognitive and motor assignmentschildren post brain injury |
| controls | Active comparator | Other: cognitive and motor assignmentschildren typically developed age matched |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- aged 10-18 understand simple commands walk independently
Key exclusion criteria (1 listed)
- Canot understand 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 |
|---|---|---|
| cognitive and motor assignmentswalking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking . | Other | brain injury, controls |
Primary outcome
Heart rate
Time frame: 5 min
Heart rate variability- time domain measures
Time frame: 5 min
Heart rate variability- frequency domain measures
Time frame: 5 min
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 19 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive and motor assignments in people with Brain Injuries, 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: finished, as of the sponsor's last update on 19 Jul 2016. 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?
Heart rate (time frame: 5 min). The study lists 3 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 19 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.