Effects of Custom Fitted Supportive Socks With Integrated Insoles in Individuals With Flat Feet

NCT07681635 | Completed

• 1 other identifier: IIUI/RERC/ADT/2025/04/178
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test if wearing custom-fitted supportive socks with built-in insoles, along with a foot exercise program, can improve foot posture, The goal of this clinical trial is to evaluate whether wearing custom-fitted supportive socks with built-in insoles, along with a foot exercise program, can improve foot posture, walking ability, and foot comfort in children aged five to twelve years with flexible flat feet. The main questions this study aims to answer are: Does the use of supportive socks with insoles and exercises improve foot posture and the shape of the foot arch? Does this combined approach improve walking ability and overall foot comfort? Researchers will compare children who wear supportive socks with built-in insoles and perform exercises to children who perform the same exercise program without the supportive socks to see which approach is more effective. Participants will: Wear the assigned supportive socks for 6-8 hours each day during daily activities if allocated to the socks group. Perform foot exercises with a physical therapist for six weeks. Take part in assessments of foot posture, walking ability, and foot comfort at the start and after six weeks Data collection is currently in progress. The findings of this study may help support non-surgical treatment options for children with flexible flat feet.

Conditions

Flat Foot

Keywords

flat foot

Outcome Measures

Primary Outcomes (2)

• Navicular Drop Test (NDT)

  The Navicular Drop Test assesses postural alignment by measuring the height difference of the navicular bone between the non-weight-bearing and weight-bearing positions. It evaluates medial arch collapse and foot pronation. Higher values = greater navicular drop → poorer postural alignment / more pronation, Lower value = better arch stability.

  Baseline

• Navicular Drop Test (NDT)

  The Navicular Drop Test assesses postural alignment by measuring the height difference of the navicular bone between the non-weight-bearing and weight-bearing positions. It evaluates medial arch collapse and foot pronation. Higher values = greater navicular drop → poorer postural alignment / more pronation, Lower value = better arch stability.

  6 weeks after intervention

Secondary Outcomes (10)

• Medial Longitudinal Arch Angle (MLAA)

  Baseline

• Medial Longitudinal Arch Angle (MLAA)

  6 weeks after intervention

• Timed Up and Go Test (TUG)

  Baseline

• Timed Up and Go Test (TUG)

  6 weeks after intervention

• Six-Minute Walk Test (6MWT)

  Baseline

Study Arms (2)

Insoles with Comprehensive Exercise

EXPERIMENTAL

Participants in this group received custom-fitted supportive socks with integrated insoles in combination with a supervised comprehensive exercise program. The intervention lasted for 6 weeks, with comprehensive exercises. Insoles were worn for 8 to 10 hours daily.

Device: Custom fitted supportive socks with integrated insoles

Comprehensive Exercise Only

ACTIVE COMPARATOR

Participants in this group received only the comprehensive exercise program, identical in content and supervision to the intervention group and lasted for 6 weeks but without the insoles or supportive socks.

Other: Comprehensive Exercise Program

Interventions

Custom fitted supportive socks with integrated insoles DEVICE

Participants in the intervention group received custom-fitted supportive socks with integrated insoles in addition to a comprehensive foot exercise program. The supportive socks were tailored to individual foot measurements and included insole aimed at correcting postural alignment, functional mobility and improving foot health.

Insoles with Comprehensive Exercise

Comprehensive Exercise Program OTHER

Participants received a structured comprehensive exercise program targeting foot intrinsic muscle strengthening, stretching, balance training, and functional mobility. The program duration was 6 weeks and did not include the use of insoles or supportive socks.

Comprehensive Exercise Only

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 5 to 12 years
• Both Gender.
• With Flexible flat feet.
• Positive navicular drop test
• Positive too many toes test, toe raising test and medial longitudinal arch angle

You may not qualify if:

• Any congenital deformity of the lower limb
• Any recent injuries
• Any recent surgeries
• Any neurological deficit
• Body Mass Index (BMI)≥25

Sponsors & Collaborators

• Ibadat International University, Islamabad: lead

Study Sites (1)

Zayneb Hospital

Islamabad, Federal, Pakistan

Location

Related Publications (3)

• Bac A, Kaczor S, Pasiut S, Scislowska-Czarnecka A, Jankowicz-Szymanska A, Filar-Mierzwa K. The influence of myofascial release on pain and selected indicators of flat foot in adults: a controlled randomized trial. Sci Rep. 2022 Jan 26;12(1):1414. doi: 10.1038/s41598-022-05401-w.

  PMID: 35082352 BACKGROUND

• Elsayed W, Alotaibi S, Shaheen A, Farouk M, Farrag A. The combined effect of short foot exercises and orthosis in symptomatic flexible flatfoot: a randomized controlled trial. Eur J Phys Rehabil Med. 2023 Jun;59(3):396-405. doi: 10.23736/S1973-9087.23.07846-2. Epub 2023 Mar 29.

  PMID: 36988565 BACKGROUND

• Brijwasi T, Borkar P. A comprehensive exercise program improves foot alignment in people with flexible flat foot: a randomised trial. J Physiother. 2023 Jan;69(1):42-46. doi: 10.1016/j.jphys.2022.11.011. Epub 2022 Dec 14.

  PMID: 36526555 BACKGROUND

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind design: The outcome assessor was blinded to the group allocation to reduce measurement bias. Participants were not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two arm parallel-group randomized controlled trial. Participants are randomly assigned to either: Intervention group: Receive custom-fitted supportive socks with integrated insoles along with comprehensive exercise program supervised by a physical therapist. Control group: Receive only comprehensive exercise program supervised by a physical therapist. Outcome measures, including foot posture, functional mobility, and foot health and comfort, are assessed at baseline and after six weeks of intervention.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: May 5, 2025
• Primary Completion: January 25, 2026
• Study Completion: January 25, 2026
• Last Updated: July 2, 2026

Record last verified: 2025-05

Locations

PA (1)