NCT02621138

Brief 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. 1.Polar monitor to record heart rate, attached to chest, in use throughout testing
  2. 2.Dynamometer- for assessing muscle strength.
  3. 3.Weights
  4. 4.5 min sitting at rest,
  5. 5.knee muscle strength assessment with the dynamometer,
  6. 6.15 minutes rest
  7. 7.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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

April 8, 2016

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

December 2, 2015

Last Update Submit

April 7, 2016

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

  • Heart rate

    40 minutes

  • Heart rate variability

    40 minutes

Study Arms (2)

cerebral palsy

Age 6-12 years Gross Motor Function Classification System I-II

control

Age 6-12 years

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children with cerebral palsy

You may qualify if:

  • GMFCS I-II
  • Unilateral CP

You may not qualify if:

  • Heart problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alyn Children's Rehabilitation Hospital

Jerusalem, 91090, Israel

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Michal Katz

CONTACT

mkatz@alyn.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 3, 2015

Study Start

April 1, 2016

Primary Completion

December 1, 2016

Last Updated

April 8, 2016

Record last verified: 2015-11

Locations

IL(1)