Corrective Exercises With Neuromuscular Electrical Stimulation In Children With Flexible Flatfeet

NCT04410926 | Completed DMC

• 1 other identifier: Children With Flatfeet
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Sports Physical Therapy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Staheli's arch index

  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.

  period of the treatment was 4 successive months

• Navicular height

  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.

  period of the treatment was4 successive months

• Radiographic indexes

  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.

  period of the treatment was 4 successive months

Study Arms (2)

control group

PLACEBO COMPARATOR

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 control group received placebo NMES with no current stimulation. In another words, the current intensity was set at 0mA while standing on both feet for 30 minutes.

Other: Corrective exercises

intervention group

EXPERIMENTAL

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. High-voltage pulsed current was set at frequency of 85 Hz with 5 seconds contraction time and 12 seconds rest time while the ramp-up and ramp-down time were 0.3 and 0.7 respectively. The current intensity was adjusted based on the individual tolerance without reporting pain or discomfort while standing on both feet. The stimulation time lasted each session for 30 minutes.

Other: Corrective exercises; Other: Neuromuscular electrical stimulation

Interventions

Corrective exercises OTHER

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

control group; intervention group

Neuromuscular electrical stimulation OTHER

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.

intervention group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, 12662, Egypt

Location

Related Publications (2)

• 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.

  PMID: 35080267 DERIVED

• 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.

  PMID: 35029841 DERIVED

Study Officials

• Emam H El-Negamy

  Cairo University

  STUDY CHAIR

• Mahmoud A Mahran

  Ain Shams University, Egypt

  STUDY DIRECTOR

• Asmaa T Ramadan

  Cairo university, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: 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

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)