ClinicalTrials.gg
CompletedNCT07681635Updated Jul 2, 2026

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

An interventional study of Custom fitted supportive socks with integrated insoles and Comprehensive Exercise Program in Flat Foot, sponsored by Ibadat International University, Islamabad. Completed at 1 site in Pakistan. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Ibadat International University, Islamabad · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled May 2025, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Flat Foot

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Keywords

  • flat foot
03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's enrollment of 56 is above the median of 40 across 122 interventional studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

Ibadat International University, Islamabad is the lead sponsor of 53 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Any congenital deformity of the lower limb
  • Any recent injuries
  • Any recent surgeries
  • Any neurological deficit
  • (BMI)≥25
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceCustom 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.

  • OtherComprehensive 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  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.

    Time frame: 6 weeks after intervention

Secondary outcomes

  1. 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

    Time frame: Baseline

  2. 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

    Time frame: 6 weeks after intervention

  3. 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

    Time frame: Baseline

  4. 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

    Time frame: 6 weeks after intervention

  5. 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

    Time frame: Baseline

  6. 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

    Time frame: 6 weeks after intervention

  7. 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

    Time frame: Baseline

  8. 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

    Time frame: 6 weeks after intervention

  9. 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

    Time frame: Baseline

  10. 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

    Time frame: 6 weeks after intervention

07

Study locations

1 site
  • Zayneb Hospital
    Islamabad, Federal, Pakistan
08

References and documents

Publications

  • 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. PubMed 35082352 ↗
  • 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. PubMed 36988565 ↗
  • 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. PubMed 36526555 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2025 to primary completion in Jan 2026, 8 months.

Of 89 non-industry interventional studies with no phase under Flatfoot, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's 8 months is above that.

Counting every sponsor, half of 89 studies reached it within 7 months; a quarter within 2 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2026
First posted
Jul 2, 2026
StartActual
May 5, 2025
Primary completionActual
Jan 25, 2026
CompletionActual
Jan 25, 2026
Last update
Jul 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07681635
Lead sponsor
Ibadat International University, Islamabad
Responsible party
Sponsor
First posted
Jul 2, 2026
Start date
May 5, 2025
Primary completion
Jan 25, 2026
Completion
Jan 25, 2026
Last update
Jul 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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