Corrective Exercises With Neuromuscular Electrical Stimulation In Children With Flexible Flatfeet
- Conditions
- Sports Physical Therapy
- Registration Number
- NCT04410926
- Lead Sponsor
- Cairo University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Radiographic indexes period of the treatment was 4 successive months Radiographic 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.
Staheli's arch index period of the treatment was 4 successive months The 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 height period of the treatment was4 successive months The 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
faculty of physical therapy, Cairo university
🇪🇬Giza, Egypt
faculty of physical therapy, Cairo university🇪🇬Giza, Egypt