Clinical trial NCT04410926: Corrective Exercises With Neuromuscular Electrical Stimulation In Children With Flexible Flatfeet
Official title: Clinical And Radiological Outcomes Of Corrective Exercises With Neuromuscular Electrical Stimulation In Children And Flexible Flatfeet: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Keywords: Foot arch
Foot print
Idiopathic flexible flatfoot
Navicular height
Short foot exercises.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 66
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention:

Corrective exercises The experimental and control groups performed a designed strengthening exercises included short-foot exercise, toes-spread-out exercise, toes-extension exercise and toe-curls for 60 minutes. Each exercise was performed for 30 repetitions holding each repetition for 5 seconds (about three minutes).

Neuromuscular electrical stimulation The experimental group received NMES aiming to reinforce the planter intrinsic foot muscles. The surface electrodes were placed over the abductor halluces based on the evidence that it has the largest cross-sectional area of the intrinsic foot muscles
Primary purpose: TREATMENT

Brief summary: flexible flatfoot is a common foot misalignment in children. various treatment procedures are used to correct or to avoid future complain among adults and pediatric population.

Detailed description: Ethics Statement This study was approved by the Institutional Review Board of the Faculty of Physical Therapy, Cairo University, Egypt (no. P.T.REC/012/0016370) and strictly adhered to the criteria proclaimed in the latest version of the Declaration of Helsinki code of ethics. Children's participation was commissioned by asking their legal guardian to sign a consent form prior to data collection.

Study design A prospective double-masked randomized controlled trial was carried out from September 1, 2018 to December 31, 2019 at the Out-patient Physical Therapy Clinic of Faculty of Physical Therapy, Cairo University.

Sample size estimation Sample size calculation was performed prior to the study using G\*POWER statistical software (version 3.1.9.2; Franz Faul, Universitat Kiel, Germany) \[F tests- MANOVA. Estimates of means of SAI were calculated from a preliminary study included 10 children who were assigned to the two treatment groups (5 children for each). Repeated measures, within-between interaction, α=0.05, β=0.2, Pillai V = 0.1, and large effect size\] and revealed that the appropriate sample size for this study was not less than 65 children. ¬then, 70 children were recruited to account for the possible dropout rates.

Randomization Seventy-two volunteer children who were recruited from governmental schools at Cairo and Giza Provinces. The online Graph Pad software was used to allocate study participants to either intervention group (corrective exercise and NMES) control group (corrective exercise and placebo NMES). All children/legal and examiners were unaware of group allocation.

Eligibility criteria: Inclusion Criteria:

The criteria for inclusion were

* Di¬agnosed (by an orthopedist) with asymptomatic FFF,
* Navicular height more than 9-millimeter (mm),
* Grade III flatfoot grade (midfoot width exceeding forefoot width)
* Normal body weight (BMI from 5th to 85th percentile),
* Presented with no neuromuscular or osseous anomalies.

Exclusion Criteria:

The authors excluded all children who had a history of

* Symptomatic flatfeet
* Congenital deformities of the lower extremities (e.g. genu valgum, femoral anteversion, leg length discrepancy, hypermobile joint)
* Scar/irri¬tated skin at the electrode placement
* Neurological/ neuromuscular disorders.

Primary outcomes:
measure: Staheli's arch index
timeFrame: period of the treatment was 4 successive months
measure: Navicular height
timeFrame: period of the treatment was4 successive months
measure: Radiographic indexes
timeFrame: period of the treatment was 4 successive months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: faculty of physical therapy, Cairo university
Study officials:
affiliation: Cairo University
name: Emam H El-Negamy
role: STUDY_CHAIR
affiliation: Ain shams university, Egypt
name: Mahmoud A Mahran
role: STUDY_DIRECTOR
affiliation: Cairo university, Egypt
name: Asmaa T Ramadan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4.
citation: Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3.