Flat FootNCT07681635
Effects of Custom Fitted Supportive Socks With Integrated Insoles in Individuals With Flat Feet
A study testing Custom fitted supportive socks with integrated insoles and Comprehensive Exercise Program in people with Flat Foot, run by Ibadat International University, Islamabad at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Flat Foot
- What is being tested?
- Custom fitted supportive socks with integrated insoles and Comprehensive Exercise Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 5 May 2025to 25 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Any congenital deformity of the lower limb
- Any recent injuries
- Any recent surgeries
- Any neurological deficit
- Body Mass Index (BMI)≥25
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
- Conditions
- Flat Foot
- Being tested
- Custom fitted supportive socks with integrated insoles, Comprehensive Exercise Program
- Keywords
- flat foot
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom fitted supportive socks with integrated insolesDevice
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 ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Insoles with Comprehensive Exercise | Experimental | 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. Receives: Device: Custom fitted supportive socks with integrated insoles |
| Comprehensive Exercise Only | Active comparator | 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. Receives: Other: Comprehensive Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks after intervention
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start5 May 2025
- Primary completion25 Jan 2026
- Study completion25 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Flat FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two arm parallel-group randomized controlled trial. Participants are randomly assigned to either: Intervention group: Receive custom-fitted supportive socks with integrated insoles along with comprehensive exercise program supervised by a physical therapist. Control group: Receive only comprehensive exercise program supervised by a physical therapist. Outcome measures, including foot posture, functional mobility, and foot health and comfort, are assessed at baseline and after six weeks of intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibadat International University, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681635
- Sponsor's protocol ID
- IIUI/RERC/ADT/2025/04/178
- Status last verified
- May 2025
- First submitted
- 26 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 35082352Elsayed 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 36988565Brijwasi 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Custom Fitted Supportive Socks With Integrated Insoles in Individuals With Flat Feet
- ClinicalTrials.gov ID
- NCT07681635
- Acronym / sponsor ID
- IIUI/RERC/ADT/2025/04/178
- Conditions
- Flat Foot
- Keywords
- flat foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ibadat International University, IslamabadUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 25 Jan 2026 (actual)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two arm parallel-group randomized controlled trial. Participants are randomly assigned to either: Intervention group: Receive custom-fitted supportive socks with integrated insoles along with comprehensive exercise program supervised by a physical therapist. Control group: Receive only comprehensive exercise program supervised by a physical therapist. Outcome measures, including foot posture, functional mobility, and foot health and comfort, are assessed at baseline and after six weeks of intervention.
| Arm | Type | Receives |
|---|---|---|
| Insoles with Comprehensive Exercise | Experimental | Device: Custom fitted supportive socks with integrated insolesParticipants 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. |
| Comprehensive Exercise Only | Active comparator | Other: Comprehensive Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Any congenital deformity of the lower limb
- Any recent injuries
- Any recent surgeries
- Any neurological deficit
- Body Mass Index (BMI)≥25
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom fitted supportive socks with integrated insolesParticipants 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. | Device | Insoles with Comprehensive Exercise |
| Comprehensive Exercise ProgramParticipants 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. | Other | Comprehensive Exercise Only |
Primary outcome
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.
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.
10 secondary outcomes
Medial Longitudinal Arch Angle (MLAA)
Time frame: Baseline
Medial Longitudinal Arch Angle (MLAA)
Time frame: 6 weeks after intervention
Timed Up and Go Test (TUG)
Time frame: Baseline
Timed Up and Go Test (TUG)
Time frame: 6 weeks after intervention
Six-Minute Walk Test (6MWT)
Time frame: Baseline
Six-Minute Walk Test (6MWT)
Time frame: 6 weeks after intervention
Foot Function Index (FFI)
Time frame: Baseline
Foot Function Index (FFI)
Time frame: 6 weeks after intervention
Foot Health Status Questionnaire (FHSQ)
Time frame: Baseline
Foot Health Status Questionnaire (FHSQ)
Time frame: 6 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Background: PubMed 35082352Bac 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.
- Background: PubMed 36988565Elsayed 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.
- Background: PubMed 36526555Brijwasi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom fitted supportive socks with integrated insoles and Comprehensive Exercise Program in people with Flat Foot, run by Ibadat International University, Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Navicular Drop Test (NDT) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07681635, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.