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

26 juni 2026 bijgewerkt door: Ibadat International University, Islamabad

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

56

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 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.
Actieve vergelijker: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Navicular Drop Test (NDT)
Tijdsspanne: 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.
Baseline
Navicular Drop Test (NDT)
Tijdsspanne: 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.
6 weeks after intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Medial Longitudinal Arch Angle (MLAA)
Tijdsspanne: 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
Baseline
Medial Longitudinal Arch Angle (MLAA)
Tijdsspanne: 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
6 weeks after intervention
Timed Up and Go Test (TUG)
Tijdsspanne: 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
Baseline
Timed Up and Go Test (TUG)
Tijdsspanne: 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
6 weeks after intervention
Six-Minute Walk Test (6MWT)
Tijdsspanne: 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
Baseline
Six-Minute Walk Test (6MWT)
Tijdsspanne: 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
6 weeks after intervention
Foot Function Index (FFI)
Tijdsspanne: 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
Baseline
Foot Function Index (FFI)
Tijdsspanne: 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
6 weeks after intervention
Foot Health Status Questionnaire (FHSQ)
Tijdsspanne: 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
Baseline
Foot Health Status Questionnaire (FHSQ)
Tijdsspanne: 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
6 weeks after intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ibadat International University, Islamabad

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 mei 2025

Primaire voltooiing (Werkelijk)

25 januari 2026

Studie voltooiing (Werkelijk)

25 januari 2026

Studieregistratiedata

Eerst ingediend

26 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2026

Eerst geplaatst (Werkelijk)

2 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

26 juni 2026

Laatst geverifieerd

1 mei 2025

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IIUI/RERC/ADT/2025/04/178

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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