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

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.

Study Overview

• Status: Completed
• Conditions: Flat Foot
• Intervention / Treatment: Device: Custom fitted supportive socks with integrated insoles; Other: Comprehensive Exercise Program

Detailed Description

This randomized controlled trial is being conducted to evaluate the effectiveness of custom-fitted supportive socks with integrated insoles combined with a comprehensive exercise program in individuals with flexible flat feet. Participants are being randomly allocated into two groups: the intervention group receives both the supportive socks with integrated insoles and an exercise program, while the control group receives the exercise program alone. The primary aim of the study is to determine the intervention's impact on postural alignment, functional mobility, and foot health. A single-blind design is being employed, with the outcome assessor blinded to group allocation. This trial aims to generate evidence regarding the use of custom-fitted supportive socks with integrated insoles in conjunction with exercises for the conservative management of flexible flat feet.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan
      • Zayneb Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Insoles with Comprehensive Exercise; 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; 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.
Active Comparator: Comprehensive Exercise Only; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medial Longitudinal Arch Angle (MLAA)	The Medial Longitudinal Arch Angle measures the structural alignment of the foot's medial arch using anatomical landmarks. It is a valid and reliable tool for assessing arch height and foot posture. Interpretation: Lower angle = collapsed arch / flat foot Higher angle = better arch height and alignment	Baseline
Medial Longitudinal Arch Angle (MLAA)	The Medial Longitudinal Arch Angle measures the structural alignment of the foot's medial arch using anatomical landmarks. It is a valid and reliable tool for assessing arch height and foot posture. Interpretation: Lower angle = collapsed arch / flat foot Higher angle = better arch height and alignment	6 weeks after intervention
Timed Up and Go Test (TUG)	The TUG test evaluates functional mobility by measuring the time it takes for a participant to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Interpretation: Lower time = better functional mobility Higher time = decreased mobility or functional limitation	Baseline
Timed Up and Go Test (TUG)	The TUG test evaluates functional mobility by measuring the time it takes for a participant to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Interpretation: Lower time = better functional mobility Higher time = decreased mobility or functional limitation	6 weeks after intervention
Six-Minute Walk Test (6MWT)	The 6MWT assesses functional endurance by measuring the total distance a participant can walk in 6 minutes on a flat surface. It reflects lower-limb function and cardiovascular capacity. Interpretation: Greater distance = better functional capacity & endurance Shorter distance = lower functional endurance	Baseline
Six-Minute Walk Test (6MWT)	The 6MWT assesses functional endurance by measuring the total distance a participant can walk in 6 minutes on a flat surface. It reflects lower-limb function and cardiovascular capacity. Interpretation: Greater distance = better functional capacity & endurance Shorter distance = lower functional endurance	6 weeks after intervention
Foot Function Index (FFI)	The Foot Function Index measures foot pain, disability, and activity limitation using three subscales: Pain (9 items), Disability (9 items), and Activity Limitation (5 items). Each item is scored 0-10 and converted to a percentage. Interpretation: Higher score = More pain, disability, and dysfunction Lower score = Better foot function	Baseline
Foot Function Index (FFI)	The Foot Function Index measures foot pain, disability, and activity limitation using three subscales: Pain (9 items), Disability (9 items), and Activity Limitation (5 items). Each item is scored 0-10 and converted to a percentage. Interpretation: Higher score = More pain, disability, and dysfunction Lower score = Better foot function	6 weeks after intervention
Foot Health Status Questionnaire (FHSQ)	The FHSQ assesses foot health across four domains: Foot Pain, Foot Function, Footwear, and General Foot Health. Domain scores are transformed to a 0-100 scale. Interpretation: Higher scores = Better foot health Lower scores = Poor foot health	Baseline
Foot Health Status Questionnaire (FHSQ)	The FHSQ assesses foot health across four domains: Foot Pain, Foot Function, Footwear, and General Foot Health. Domain scores are transformed to a 0-100 scale. Interpretation: Higher scores = Better foot health Lower scores = Poor foot health	6 weeks after intervention

Collaborators and Investigators

• Sponsor: Ibadat International University, Islamabad

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Actual): January 25, 2026
• Study Completion (Actual): January 25, 2026

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: flat foot
• Additional Relevant MeSH Terms: Talipes; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Flatfoot
• Other Study ID Numbers: IIUI/RERC/ADT/2025/04/178

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No