The Influence of Muscle Contraction on the Cardiac Autonomic System

Cerebral Palsy Clinical Trial

Official title:

The Influence of Muscle Contraction on the Cardiac Autonomic System at Rest and Activity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02621138
• Other study ID #: 283-15
• Status: Not yet recruiting
• Phase: N/A
• First received: December 2, 2015
• Last updated: April 7, 2016
• Start date: April 2016

Study information

• Verified date: November 2015
• Source: Alyn Pediatric & Adolecent Rehabilitation Center
• Contact: Michal Katz
• Email: mkatz[@]alyn.org
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical 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. Weights

Method:

Each child will be tested once. Both tools will be demonstrated and tried out before actual testing.

With Polar watch attached:

1. 5 min sitting at rest,

2. knee muscle strength assessment with the dynamometer,

3. 15 minutes rest

4. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• GMFCS I-II

• Unilateral CP

Exclusion Criteria:

• Heart problems

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
Israel	Alyn Children's Rehabilitation Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Alyn Pediatric & Adolecent Rehabilitation Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate		40 minutes	No
Primary	Heart rate variability		40 minutes	No