Forefoot Adduction Clinical Trial
Official title:
Difference of Neuromuscular Activity in Infants and Toddlers With Foot Dorsiflexion Compare to Infants and Toddlers With Foot Plantarflexion
| NCT number | NCT00470756 |
| Other study ID # | SIM03-HMO-CTILL |
| Secondary ID | |
| Status | Suspended |
| Phase | Phase 2 |
| First received | May 6, 2007 |
| Last updated | May 11, 2011 |
| Start date | March 2008 |
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.
| Status | Suspended |
| Enrollment | 20 |
| Est. completion date | |
| Est. primary completion date | March 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Months to 1 Year |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Israel | Hadassah Medical Organization. | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Hadassah Medical Organization |
Israel,