- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02621138
The Influence of Muscle Contraction on the Cardiac Autonomic System
April 7, 2016 updated by: Alyn Pediatric & Adolescent Rehabilitation Hospital
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.
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 Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michal Katz
- Email: mkatz@alyn.org
Study Locations
-
-
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Jerusalem, Israel, 91090
- Alyn Children's Rehabilitation Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
children with cerebral palsy
Description
Inclusion Criteria:
- GMFCS I-II
- Unilateral CP
Exclusion Criteria:
- Heart problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
cerebral palsy
Age 6-12 years Gross Motor Function Classification System I-II
|
control
Age 6-12 years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate
Time Frame: 40 minutes
|
40 minutes
|
Heart rate variability
Time Frame: 40 minutes
|
40 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
December 2, 2015
First Submitted That Met QC Criteria
December 2, 2015
First Posted (Estimate)
December 3, 2015
Study Record Updates
Last Update Posted (Estimate)
April 8, 2016
Last Update Submitted That Met QC Criteria
April 7, 2016
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 283-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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