Corrective Exercises With Neuromuscular Electrical Stimulation In Children With Flexible Flatfeet

NCT ID: NCT04410926

Last Updated: 2022-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-12-31

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.

Conditions

Sports Physical Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

control group

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.

Group Type: PLACEBO_COMPARATOR

Corrective exercises

Intervention Type: 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

intervention group

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.

Group Type: EXPERIMENTAL

Corrective exercises

Intervention Type: 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

Neuromuscular electrical stimulation

Intervention Type: 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.

Interventions

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

Intervention Type: OTHER

Neuromuscular 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amira Mahmoud Abd-elmonem

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emam H El-Negamy

Role: STUDY_CHAIR

Cairo University

Mahmoud A Mahran

Role: STUDY_DIRECTOR

Ain shams university, Egypt

Asmaa T Ramadan

Role: PRINCIPAL_INVESTIGATOR

Cairo university, Egypt

Locations

faculty of physical therapy, Cairo university

Giza, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 35080267 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35029841 (View on PubMed)

Other Identifiers

Children With Flatfeet

Identifier Type: -

Identifier Source: org_study_id