Cerebral PalsyNCT02621138
The Influence of Muscle Contraction on the Cardiac Autonomic System
An observational study of Cerebral Palsy, run by Alyn Pediatric & Adolescent Rehabilitation Hospital at 1 site in Israel.
Trial summary
Population: 16 children with cerebral palsy, GMFCS 1-3.16 children typically developed, matched for age. All children aged 6-12 yrs who understand simple commands. Tools: 1. Polar monitor to record heart rate, attached to chest, in use throughout testing 2. Dynamometer- for assessing muscle strength. 3. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Dec 2016
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Child
Study population: children with cerebral palsy
Who may be able to join
- GMFCS I-II
- Unilateral CP
Who cannot join
- Heart problems
Trial locations and contacts
1 site in 1 country.
Michal Katz contact
About this study
Official title: The Influence of Muscle Contraction on the Cardiac Autonomic System at Rest and Activity
Population:
16 children with cerebral palsy, GMFCS 1-3.16 children typically developed, matched for age.
Read more
All children aged 6-12 yrs who understand simple commands.
Tools:
- Polar monitor to record heart rate, attached to chest, in use throughout testing
- Dynamometer- for assessing muscle strength.
- Weights
Method:
Each child will be tested once. Both tools will be demonstrated and tried out before actual testing.
With Polar watch attached:
- 5 min sitting at rest,
- knee muscle strength assessment with the dynamometer,
- 15 minutes rest
- Isometric and isotonic knee muscle contraction at 30% of childs' maximal strength as has assessed by the dynamometer. The child will asked to perform each for 3 minutes, with 5 minutes rest in-between All will be perform in both legs.
- Conditions
- Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cerebral palsy | Age 6-12 years Gross Motor Function Classification System I-II | |
| control | Age 6-12 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Measured: 40 minutes
Heart rate variability
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startApr 2016
- Primary completionDec 2016 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (estimated)
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
- NCT02621138
- Sponsor's protocol ID
- 283-15
- Status last verified
- Nov 2015
- First submitted
- 2 Dec 2015
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Muscle Contraction on the Cardiac Autonomic System at Rest and Activity
- ClinicalTrials.gov ID
- NCT02621138
- Acronym / sponsor ID
- 283-15
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Alyn Pediatric & Adolescent Rehabilitation HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (estimated)
- First posted
- 3 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.
Population:
16 children with cerebral palsy, GMFCS 1-3.16 children typically developed, matched for age.
All children aged 6-12 yrs who understand simple commands.
Tools:
- Polar monitor to record heart rate, attached to chest, in use throughout testing
- Dynamometer- for assessing muscle strength.
- Weights
Method:
Each child will be tested once. Both tools will be demonstrated and tried out before actual testing.
With Polar watch attached:
- 5 min sitting at rest,
- knee muscle strength assessment with the dynamometer,
- 15 minutes rest
- Isometric and isotonic knee muscle contraction at 30% of childs' maximal strength as has assessed by the dynamometer. The child will asked to perform each for 3 minutes, with 5 minutes rest in-between All will be perform in both legs.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cerebral palsy | – | –Age 6-12 years Gross Motor Function Classification System I-II |
| control | – | –Age 6-12 years |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children with cerebral palsy
Key inclusion criteria (2 listed)
- GMFCS I-II
- Unilateral CP
Key exclusion criteria (1 listed)
- Heart problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart rate
Time frame: 40 minutes
Heart rate variability
Time frame: 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
- Individual participant dataSharing planned: Undecided
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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.
Michal Katz contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 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: status not confirmed, as of the sponsor's last update on 8 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Katz (mkatz@alyn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 40 minutes). 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 8 Apr 2016.