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Corrective Exercises With Neuromuscular Electrical Stimulation In Children With Flexible Flatfeet

Clinical And Radiological Outcomes Of Corrective Exercises With Neuromuscular Electrical Stimulation In Children And Flexible Flatfeet: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04410926
Enrollment
66
Registered
2020-06-01
Start date
2018-09-01
Completion date
2019-12-31
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sports Physical Therapy

Keywords

Foot arch, Foot print, Idiopathic flexible flatfoot, Navicular height, Short foot exercises.

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.

Interventions

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

OTHERNeuromuscular electrical stimulation

The experimental group received NMES aiming to reinforce the planter intrinsic foot muscles for 30 minutes. The surface electrodes were placed over the abductor halluces. The control group received placebo NMES with no current stimulation.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

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

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Staheli's arch indexperiod of the treatment was 4 successive monthsThe footprint is one of the easy, cost effective, noninvasive and objective measures for assessing the SAI. A value of SAI \>1.15 indicates flatfeet.
Navicular heightperiod of the treatment was4 successive monthsThe navicular height was measured by the navicular drop test first described by Brody21 to evaluate the amount of foot pronation. Measurements of 6-9 mm are considered to be within the normal range. It represents the vertical extension between the most prominent point of the navicular and the supporting surface.
Radiographic indexesperiod of the treatment was 4 successive monthsRadiographic indexes were carried out through bilateral radiographs encompassing horizontal (antero-posterior) and sagittal (lateral) views obtained with the child in a relaxed bipedal weight-bearing erect standing.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026