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Forefoot Adduction (FFA) in Infants and Toddlers. Differences of Neuromuscular Activity.

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00470756
First Posted: May 8, 2007
Last Update Posted: May 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose

Every week we encounter with 5-8 pairs of worried parents of infants with forefoot adduction. Most of them usually need only reassurance and education how to manipulate the deformed foot. During the examination we usually use provocative maneuver to trigger peroneal activity. This manual stimulation usually reveals active eversion and dorsiflexion of the foot in most of the children, but not in all of them. Small part of the children reacts in opposite direction - instead of the typical eversion they demonstrate inversion and some plantar flexion of the foot. We have the impression that this subgroup of children improves the deformity slower and sometime less complete than most of the children. We did not find in the literature any description of this phenomenon. We postulate, that atypically reacting patients probably have different response due to abnormalities of neuromuscular balance between invertors-flexors and evertors-extensors muscle groups. This small subgroup of children may need more close follow-up and probably casting to speed up and secure the improvement of their deformity.

Study goals:

  1. Evaluate ability of children with FFA to respond on mechanical triggering of peroneal activity

    1. The majority of the patients with standard reaction - foot dorsiflexion and eversion (evertors)
    2. The minority of the patients with nonstandard reaction - foot plantarflexion and inversion (invertors)
  2. Evaluate randomly selected children from each group for character of muscular response on electrical stimulation (EMG) of calf muscles.

Condition Intervention Phase
Forefoot Adduction Other: mechanical triggering of peroneal activity Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Difference of Neuromuscular Activity in Infants and Toddlers With Foot Dorsiflexion Compare to Infants and Toddlers With Foot Plantarflexion

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 20
Study Start Date: March 2008
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
evertors, invertors Other: mechanical triggering of peroneal activity
mechanical triggering of peroneal activity

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
infants and toddlers with Forefoot adduction
Criteria

Inclusion Criteria:

  1. Boys and girls between two months and one year old.
  2. Non associated pathology.
  3. Signing Informed consent.

Exclusion Criteria:

  1. Unwillingness to sign informed consent.
  2. Associated pathology
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470756


Locations
Israel
Hadassah Medical Organization.
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Naum Simanovski, MD Hadassah Medical Organization
  More Information

Responsible Party: Naum Simanovski, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00470756     History of Changes
Other Study ID Numbers: SIM03-HMO-CTILL
First Submitted: May 6, 2007
First Posted: May 8, 2007
Last Update Posted: May 12, 2011
Last Verified: April 2011