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Completed

NCT Number: NCT07681635

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.

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Key information

Conditions

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

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zayneb Hospital

Islamabad, Federal, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Navicular Drop Test (NDT)

    Time frame: Baseline

    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.

  2. Navicular Drop Test (NDT)

    Time frame: 6 weeks after intervention

    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.

Secondary outcomes

  1. Medial Longitudinal Arch Angle (MLAA)

    Time frame: Baseline

    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

  2. Medial Longitudinal Arch Angle (MLAA)

    Time frame: 6 weeks after intervention

    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

  3. Timed Up and Go Test (TUG)

    Time frame: Baseline

    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

  4. Timed Up and Go Test (TUG)

    Time frame: 6 weeks after intervention

    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

  5. Six-Minute Walk Test (6MWT)

    Time frame: Baseline

    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. Six-Minute Walk Test (6MWT)

    Time frame: 6 weeks after intervention

    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

  7. Foot Function Index (FFI)

    Time frame: Baseline

    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

  8. Foot Function Index (FFI)

    Time frame: 6 weeks after intervention

    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

  9. Foot Health Status Questionnaire (FHSQ)

    Time frame: Baseline

    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

  10. Foot Health Status Questionnaire (FHSQ)

    Time frame: 6 weeks after intervention

    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

Sponsors and collaborators

Lead sponsor

Ibadat International University, Islamabad

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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