Flexible FlatfootNCT05877482
Pediatric Pes Planus: Effect of Insoles With and Without SFE
A study testing Short foot exercises and Insoles in people with Flexible Flatfoot, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this randomised control trial is to determine the effects of insoles with and without short foot exercises on pain, disability and foot posture in children with pes planus. The main question[s] it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Flexible Flatfoot
- What is being tested?
- Short foot exercises and Insoles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2023to 1 Sep 2023
- 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 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Having bilateral pes planus according to Navicular Drop (ND) exceeding 10 mm
- six item Foot Posture Index (FPI) score 6 to 12
Who cannot join
- Children having rigid pes planus,
- Hallux valgus,
- Hallux rigidus,
- Epin calcanei,
- Systemic, neurological or orthopedic problems that can affect the lower extremity,
- History of surgery on the lower extremities.
- Musculoskeletal pathologies, open wound in foot or a previous spinal/lower limb surgery
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Children Hospital Lahore
Lahore, Punjab Province, 54000
Eram Aslam, MS, 03367034716, doctor.eram786@gmail.com
Eram Aslam, MS
About this study
Official title: Effect of Insoles With and Without Short Foot Exercises on Pain, Disability and Foot Posture in Children With Pes Planus
The goal of this randomised control trial is to determine the effects of insoles with and without short foot exercises on pain, disability and foot posture in children with pes planus.
The main question[s] it aims to answer are:
Read more
- What are the effects of insoles on pain, disability, and foot posture in children with pes planus?
- What are the effects of short foot exercises on pain, disability, and foot posture in children with pes planus?
- What are the combined effects of insoles and short foot exercises on pain, disability, and foot posture in children with pes planus?
- Is there a significant difference between the effects of insoles alone versus insoles with short foot exercises on pain, disability, and foot posture in children with pes planus?
Participants will be asked to signed consent form and divided into two groups. Experimental group will be asked to performed short foot exercises with internal shoe modification (a medial longitudinal arch support) daily for six weeks and Control Group will be asked to perform only internal shoe modification by placing a medial longitudinal arch support insoles inside the shoe.
Researchers will compare:
- Insoles only vs insoles + short foot exercises: This comparison would involve evaluating the effects of wearing insoles alone compared to wearing insoles and performing short foot exercises together to see effect on pain, disability, and foot posture among pes planus children between age group of 08 to 16 years.
Read the detailed description
All participants will be informed about the study, and an informed consent form was signed by each participant. A total of 26 participants with pes planus will be assigned, to the short-foot exercises group (n = 13) and the control group (n = 13). Both groups will be informed about pes planus, usual foot care, and appropriate footwear with individually designed foot insoles. In experimental group Short foot exercises (SFE) and internal shoe modification will be performed by placing an individually designed medial longitudinal arch support insoles inside the shoe. Exercises will be performed daily for six weeks. While in control group only internal shoe modification will be performed. Short-foot exercises group will be performed the exercises daily for 6 weeks. Normality of data checked by the Shapiro wilk test. If the P-value is more than 0.05 then para metric test will applied and if P value is less than 0.05 than it is non-parametric. SPSS version 25.0 statistical software will be used. This study will examine the effects of individually designed insole in pes planus treatment with and without short foot exercises to improve the physical performance parameters and minimize the complaints of the individuals with pes planus.
- Conditions
- Flexible Flatfoot
- Being tested
- Short foot exercises, Insoles
- Keywords
- Short foot exercises, Pes Planus, Flat Feet, Insoles, Foot Posture Index, Navicular drop test
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short foot exercisesOther
A total of 26 participants with pes planus were assigned to the short-foot exercises group (n = 13) and the control group (n = 13). Both groups will be informed about pes planus, usual foot care, and appropriate footwear with foot insoles. In experimental group Short foot exercises (SFE) and internal shoe modification will be performed by placing a medial longitudinal arch support insoles inside the shoe. Exercises will be performed daily for six weeks.
InsolesOther
In control group only internal shoe modification will be performed by placing medial longitudinal arch support insoles inside the shoe. Group assignment and SFE training will be conducted by the second physical therapist to provide blindness.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Short foot exercises with internal shoe modification (a medial longitudinal arch support) will be performed daily for six weeks. Receives: Other: Short foot exercises; Other: Insoles |
| Control Group | No intervention | Only internal shoe modification will be performed by placing a medial longitudinal arch support insoles inside the shoe. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Navicular Drop (ND) test for inclusion criteria
The Navicular Drop Test (NDT) was first described by Brody in 1982 as a means of quantifying the amount of foot pronation in runners. It is the one of the static foot assessment tool and is intended to represent the sagittal plane displacement of the navicular tuberosity from a neutral position i.e. Subtalar joint neutral to a relaxed position in standing.
Measured: 1st week
Secondary outcomes (2)
Six item Foot Posture Index (FPI)
The FPI-6 is a novel method of rating foot posture using set criteria and a simple scale. It is a clinical tool used to quantify the degree to which a foot is pronated, neutral or supinated. It is a measure of standing foot posture and so is not a replacement for gait assessment where time and facilities exist. It is however a more valid approach than many of the static weight bearing and non-weight bearing goniometric measures currently used in clinic.
Measured: 6th week
Pain and disability were assessed by pain and disability subscales (both include 9 items) of the Foot Function Index (FFI)
A Foot Function Index (FFI) was developed in 1991 to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. [1] It is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Mar 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Flexible FlatfootStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Arnab Altaf, BSPT,Mphil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877482
- Sponsor's protocol ID
- REC/RCR & AHS/22/0719
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alazzawi S, Sukeik M, King D, Vemulapalli K. Foot and ankle history and clinical examination: A guide to everyday practice. World J Orthop. 2017 Jan 18;8(1):21-29. doi: 10.5312/wjo.v8.i1.21. eCollection 2017 Jan 18.
PubMed 28144575Gwani AS, Asari MA, Mohd Ismail ZI. How the three arches of the foot intercorrelate. Folia Morphol (Warsz). 2017;76(4):682-688. doi: 10.5603/FM.a2017.0049. Epub 2017 May 29.
PubMed 28553850Acak M. The effects of individually designed insoles on pes planus treatment. Sci Rep. 2020 Nov 12;10(1):19715. doi: 10.1038/s41598-020-76767-y.
PubMed 33184442Caravaggi P, Pataky T, Gunther M, Savage R, Crompton R. Dynamics of longitudinal arch support in relation to walking speed: contribution of the plantar aponeurosis. J Anat. 2010 Sep;217(3):254-61. doi: 10.1111/j.1469-7580.2010.01261.x. Epub 2010 Jul 14.
PubMed 20646107Hashimoto T, Sakuraba K. Strength training for the intrinsic flexor muscles of the foot: effects on muscle strength, the foot arch, and dynamic parameters before and after the training. J Phys Ther Sci. 2014 Mar;26(3):373-6. doi: 10.1589/jpts.26.373. Epub 2014 Mar 25.
PubMed 24707086McCormack AP, Ching RP, Sangeorzan BJ. Biomechanics of procedures used in adult flatfoot deformity. Foot Ankle Clin. 2001 Mar;6(1):15-23, v. doi: 10.1016/s1083-7515(03)00072-x.
PubMed 11385922Chevalier TL, Chockalingam N. Effects of foot orthoses: How important is the practitioner? Gait Posture. 2012 Mar;35(3):383-8. doi: 10.1016/j.gaitpost.2011.10.356. Epub 2011 Nov 21.
PubMed 22104292Nawoczenski DA, Saltzman CL, Cook TM. The effect of foot structure on the three-dimensional kinematic coupling behavior of the leg and rear foot. Phys Ther. 1998 Apr;78(4):404-16. doi: 10.1093/ptj/78.4.404.
PubMed 9555923Yurt Y, Sener G, Yakut Y. The effect of different foot orthoses on pain and health related quality of life in painful flexible flat foot: a randomized controlled trial. Eur J Phys Rehabil Med. 2019 Feb;55(1):95-102. doi: 10.23736/S1973-9087.18.05108-0. Epub 2018 Mar 16.
PubMed 29553223Unver B, Erdem EU, Akbas E. Effects of Short-Foot Exercises on Foot Posture, Pain, Disability, and Plantar Pressure in Pes Planus. J Sport Rehabil. 2019 Oct 18;29(4):436-440. doi: 10.1123/jsr.2018-0363. Print 2020 May 1.
PubMed 30860412Yildirim Sahan T, Aydogan Arslan S, Demirci C, Oktas B, Sertel M. Comparison Of Short-Term Effects Of Virtual Reality and Short Foot Exercises In Pes Planus. Foot (Edinb). 2021 Jun;47:101778. doi: 10.1016/j.foot.2021.101778. Epub 2021 Jan 21.
PubMed 33962115Taspinar O, Kabayel DD, Ozdemir F, Tuna H, Keskin Y, Mercimek OB, Sut N, Yavuz S, Tuna F. Comparing the efficacy of exercise, internal and external shoe modification in pes planus: A clinical and pedobarographic study. J Back Musculoskelet Rehabil. 2017;30(2):255-263. doi: 10.3233/BMR-150399.
PubMed 27858680
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Insoles With and Without Short Foot Exercises on Pain, Disability and Foot Posture in Children With Pes Planus
- ClinicalTrials.gov ID
- NCT05877482
- Acronym / sponsor ID
- REC/RCR & AHS/22/0719
- Conditions
- Flexible Flatfoot
- Keywords
- Short foot exercises, Pes Planus, Flat Feet, Insoles, Foot Posture Index, Navicular drop test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 26 May 2023 (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 randomised control trial is to determine the effects of insoles with and without short foot exercises on pain, disability and foot posture in children with pes planus.
The main question[s] it aims to answer are:
- What are the effects of insoles on pain, disability, and foot posture in children with pes planus?
- What are the effects of short foot exercises on pain, disability, and foot posture in children with pes planus?
- What are the combined effects of insoles and short foot exercises on pain, disability, and foot posture in children with pes planus?
- Is there a significant difference between the effects of insoles alone versus insoles with short foot exercises on pain, disability, and foot posture in children with pes planus?
Participants will be asked to signed consent form and divided into two groups. Experimental group will be asked to performed short foot exercises with internal shoe modification (a medial longitudinal arch support) daily for six weeks and Control Group will be asked to perform only internal shoe modification by placing a medial longitudinal arch support insoles inside the shoe.
Researchers will compare:
- Insoles only vs insoles + short foot exercises: This comparison would involve evaluating the effects of wearing insoles alone compared to wearing insoles and performing short foot exercises together to see effect on pain, disability, and foot posture among pes planus children between age group of 08 to 16 years.
Detailed description
All participants will be informed about the study, and an informed consent form was signed by each participant. A total of 26 participants with pes planus will be assigned, to the short-foot exercises group (n = 13) and the control group (n = 13). Both groups will be informed about pes planus, usual foot care, and appropriate footwear with individually designed foot insoles. In experimental group Short foot exercises (SFE) and internal shoe modification will be performed by placing an individually designed medial longitudinal arch support insoles inside the shoe. Exercises will be performed daily for six weeks. While in control group only internal shoe modification will be performed. Short-foot exercises group will be performed the exercises daily for 6 weeks. Normality of data checked by the Shapiro wilk test. If the P-value is more than 0.05 then para metric test will applied and if P value is less than 0.05 than it is non-parametric. SPSS version 25.0 statistical software will be used. This study will examine the effects of individually designed insole in pes planus treatment with and without short foot exercises to improve the physical performance parameters and minimize the complaints of the individuals with pes planus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Short foot exercises, Other: InsolesShort foot exercises with internal shoe modification (a medial longitudinal arch support) will be performed daily for six weeks. |
| Control Group | No intervention | –Only internal shoe modification will be performed by placing a medial longitudinal arch support insoles inside the shoe. |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Having bilateral pes planus according to Navicular Drop (ND) exceeding 10 mm
- six item Foot Posture Index (FPI) score 6 to 12
Key exclusion criteria (7 listed)
- Children having rigid pes planus,
- Hallux valgus,
- Hallux rigidus,
- Epin calcanei,
- Systemic, neurological or orthopedic problems that can affect the lower extremity,
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 |
|---|---|---|
| Short foot exercisesA total of 26 participants with pes planus were assigned to the short-foot exercises group (n = 13) and the control group (n = 13). Both groups will be informed about pes planus, usual foot care, and appropriate footwear with foot insoles. In experimental group Short foot exercises (SFE) and internal shoe modification will be performed by placing a medial longitudinal arch support insoles inside the shoe. Exercises will be performed daily for six weeks. | Other | Experimental Group |
| InsolesIn control group only internal shoe modification will be performed by placing medial longitudinal arch support insoles inside the shoe. Group assignment and SFE training will be conducted by the second physical therapist to provide blindness. | Other | Experimental Group |
Primary outcome
Navicular Drop (ND) test for inclusion criteria
Time frame: 1st week
The Navicular Drop Test (NDT) was first described by Brody in 1982 as a means of quantifying the amount of foot pronation in runners. It is the one of the static foot assessment tool and is intended to represent the sagittal plane displacement of the navicular tuberosity from a neutral position i.e. Subtalar joint neutral to a relaxed position in standing.
2 secondary outcomes
Six item Foot Posture Index (FPI)
Time frame: 6th week
Pain and disability were assessed by pain and disability subscales (both include 9 items) of the Foot Function Index (FFI)
Time frame: 6th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Background: PubMed 28144575Alazzawi S, Sukeik M, King D, Vemulapalli K. Foot and ankle history and clinical examination: A guide to everyday practice. World J Orthop. 2017 Jan 18;8(1):21-29. doi: 10.5312/wjo.v8.i1.21. eCollection 2017 Jan 18.
- Background: PubMed 28553850Gwani AS, Asari MA, Mohd Ismail ZI. How the three arches of the foot intercorrelate. Folia Morphol (Warsz). 2017;76(4):682-688. doi: 10.5603/FM.a2017.0049. Epub 2017 May 29.
- Background: PubMed 33184442Acak M. The effects of individually designed insoles on pes planus treatment. Sci Rep. 2020 Nov 12;10(1):19715. doi: 10.1038/s41598-020-76767-y.
- Background: PubMed 20646107Caravaggi P, Pataky T, Gunther M, Savage R, Crompton R. Dynamics of longitudinal arch support in relation to walking speed: contribution of the plantar aponeurosis. J Anat. 2010 Sep;217(3):254-61. doi: 10.1111/j.1469-7580.2010.01261.x. Epub 2010 Jul 14.
- Background: PubMed 24707086Hashimoto T, Sakuraba K. Strength training for the intrinsic flexor muscles of the foot: effects on muscle strength, the foot arch, and dynamic parameters before and after the training. J Phys Ther Sci. 2014 Mar;26(3):373-6. doi: 10.1589/jpts.26.373. Epub 2014 Mar 25.
- Background: PubMed 11385922McCormack AP, Ching RP, Sangeorzan BJ. Biomechanics of procedures used in adult flatfoot deformity. Foot Ankle Clin. 2001 Mar;6(1):15-23, v. doi: 10.1016/s1083-7515(03)00072-x.
- Background: PubMed 22104292Chevalier TL, Chockalingam N. Effects of foot orthoses: How important is the practitioner? Gait Posture. 2012 Mar;35(3):383-8. doi: 10.1016/j.gaitpost.2011.10.356. Epub 2011 Nov 21.
- Background: PubMed 9555923Nawoczenski DA, Saltzman CL, Cook TM. The effect of foot structure on the three-dimensional kinematic coupling behavior of the leg and rear foot. Phys Ther. 1998 Apr;78(4):404-16. doi: 10.1093/ptj/78.4.404.
- Background: PubMed 29553223Yurt Y, Sener G, Yakut Y. The effect of different foot orthoses on pain and health related quality of life in painful flexible flat foot: a randomized controlled trial. Eur J Phys Rehabil Med. 2019 Feb;55(1):95-102. doi: 10.23736/S1973-9087.18.05108-0. Epub 2018 Mar 16.
- Background: PubMed 30860412Unver B, Erdem EU, Akbas E. Effects of Short-Foot Exercises on Foot Posture, Pain, Disability, and Plantar Pressure in Pes Planus. J Sport Rehabil. 2019 Oct 18;29(4):436-440. doi: 10.1123/jsr.2018-0363. Print 2020 May 1.
- Background: PubMed 33962115Yildirim Sahan T, Aydogan Arslan S, Demirci C, Oktas B, Sertel M. Comparison Of Short-Term Effects Of Virtual Reality and Short Foot Exercises In Pes Planus. Foot (Edinb). 2021 Jun;47:101778. doi: 10.1016/j.foot.2021.101778. Epub 2021 Jan 21.
- Background: PubMed 27858680Taspinar O, Kabayel DD, Ozdemir F, Tuna H, Keskin Y, Mercimek OB, Sut N, Yavuz S, Tuna F. Comparing the efficacy of exercise, internal and external shoe modification in pes planus: A clinical and pedobarographic study. J Back Musculoskelet Rehabil. 2017;30(2):255-263. doi: 10.3233/BMR-150399.
- Individual participant dataSharing planned: No
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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.
Dr. Arnab Altaf, BSPT,Mphil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short foot exercises and Insoles in people with Flexible Flatfoot, run by Riphah International University 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Arnab Altaf, BSPT,MPhil (03064585776, arnab.altaf@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Navicular Drop (ND) test for inclusion criteria (time frame: 1st week). 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 NCT05877482, which also lists 12 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 26 May 2023.