Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

26. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

56

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: 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.
Aktiv komparator: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Navicular Drop Test (NDT)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medial Longitudinal Arch Angle (MLAA)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ibadat International University, Islamabad

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. maj 2025

Primær færdiggørelse (Faktiske)

25. januar 2026

Studieafslutning (Faktiske)

25. januar 2026

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2026

Sidst verificeret

1. maj 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IIUI/RERC/ADT/2025/04/178

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner