Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Corrective Exercises With Neuromuscular Electrical Stimulation In Children With Flexible Flatfeet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410926
Recruitment Status : Completed
First Posted : June 1, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Amira M Abd-elmonem, PHD, 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.

Condition or disease Intervention/treatment Phase
Sports Physical Therapy Other: Corrective exercises Other: Neuromuscular electrical stimulation Not Applicable

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 par¬ticipation 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 Sixty-seven 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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

Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical And Radiological Outcomes Of Corrective Exercises With Neuromuscular Electrical Stimulation In Children With Flexible Flatfeet: A Randomized Controlled Trial
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 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.

Other: 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

Experimental: 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.

Other: 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

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.




Primary Outcome Measures :
  1. Staheli's arch index [ Time Frame: period of the treatment was 6 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.

  2. Navicular height [ Time Frame: period of the treatment was 6 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.

  3. Radiographic indexes [ Time Frame: period of the treatment was 6 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410926


Locations
Layout table for location information
Egypt
faculty of physical therapy, Cairo university
Giza, Egypt, 12662
Sponsors and Collaborators
Cairo University
Layout table for additonal information
Responsible Party: Amira M Abd-elmonem, PHD, principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT04410926    
Other Study ID Numbers: Children With Flatfeet
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amira M Abd-elmonem, PHD, Cairo University:
Foot arch
Foot print
Idiopathic flexible flatfoot
Navicular height
Short foot exercises.
Additional relevant MeSH terms:
Layout table for MeSH terms
Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities