Pes PlanusNCT05764967
Low Dye Taping Technique and Temporary Felt Insoles on Pain and Disability in Children With Pes Planus.
A study testing Low Dye Taping and Temporary Felt Insoles in people with Pes Planus, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to determine comparative effects of low dye taping technique and temporary felt insoles on pain and disability in children with pes planus. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Low Dye Taping and Temporary Felt Insoles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2022to 5 Apr 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6-12year
- vertical navicular height of 10 mm or more
- A Vernier height gauge (Mitutoyo Corp, Tokyo, Japan) calibrated to 0.02 mm was used to measure vertical navicular height.
Who cannot join
- current injuries to the lower extremities that had required a reduction in activity levels and/or treatment by a health-care practitioner.
- severe orthopedic or neurologic conditions, and a known allergy to sports tape.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects Of Low Dye Taping Technique And Temporary Felt Insoles On Pain And Disability In Children With Pes Planus
This study aims to determine comparative effects of low dye taping technique and temporary felt insoles on pain and disability in children with pes planus.
Read the detailed description
Pes planus is a foot arch deformity, is also known as flexible flat foot. Foot arch plays an important role in cushioning ground impact and stabilizing the body in standing and walking. Children with pes planus lack an elastic foot arch to attenuate the impact force. This condition results in pain and impaired lower limb function. Low Dye taping and shoe insoles are used to treat Pes Planus. Low Dye taping technique is designed to off-load the plantar fascia and provide medial ankle arch support. It is a classic taping method incorporating functional mechanical support of the foot and ankle. Low-Dye taping is commonly used to support the longitudinal and transverse arches of the foot.
A shoe insole is the footbed or material inside the shoe that the bottom or plantar surface of your foot lays on. In most well-made shoes today, the material or insole is removable. There are shoes that have glued in insoles, however in general these are shoes that are not as well made. The removable insoles that come in most shoes vary in type and material ranging from very simple thin cushioning to sophisticated multiple layered arch support inserts. The aim of this study is to compare the effects of Low dye taping and shoe insoles on pain and disability in children with pes planus.
The study will be Randomized Clinical trial. Total twenty four subjects will be assigned randomly by using block randomization into two groups (12 in each group). Both Groups will be experimental groups. Group A will be given low dye taping and Group B would be given temporary felt insoles. After confirmation of diagnosis with medical history and physical examination as well as different movement palpation tests and pain provocation tests are recommended. The Foot and Ankle Ability Measure (FAAM) and Numeric Pain Rating Scale (NPR) would be used as an outcome measure tools for pain and disability respectively. Measure will be taken at (Baseline and at the end of treatment session). The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 27.0. Parametric/non-parametric tests will be applied after testing normality of data.
- Conditions
- Pes Planus
- Being tested
- Low Dye Taping, Temporary Felt Insoles
- Keywords
- Disability, Insoles, Low Dye Taping, Pain, Pes Planus
- Medical subject headings
- Flatfoot, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dye TapingOther
The augmented low-Dye technique, involves applying a device consisting of a spur and mini-stirrups to the foot and then adding reverse sixes and calcaneal slings to an anchor on the distal one-third of the leg. A rigid 38-mm sports tape with zinc oxide adhesive is used for all of the taping procedures.
Temporary Felt InsolesOther
A temporary orthosis is fabricated from 7-mm orthopedic felt.The subject stands on his or her template while the TTR pointer is attached to the medial tibial plateau of the leg using a Velcro strap. An outline of the position of the device on the tibial plateau is drawn onto the skin with an indelible ink pen to allow for accurate relocation between all trials. TTR is measured in relaxed calcaneal stance while the subject wearing shoes. Measurements are recorded onto a data-collection sheet. Each measurement performes twice. The subject are given orthosis inserted into the shoe. All shoes are visually assessed to ensure that they will not induce pronation or internal rotation.
| Study group | Role | What they receive |
|---|---|---|
| Low Dye Taping | Experimental | One Arm will be given Low Dye taping. The augmented low-Dye technique, involves applying a device consisting of a spur and mini-stirrups to the foot and then adding reverse sixes and calcaneal slings to an anchor on the distal one-third of the leg. A rigid 38-mm sports tape with zinc oxide adhesive will be used for all of the taping procedures. Prior to application of the tape, any hair in the region will be shaved and the foot and leg will be washed with soap and warm water to remove any dirt or oils that might decrease the adhesion of the tape. The Transverse Tibial Rotation (TTR) measurements will be repeated following application of tape. Receives: Other: Low Dye Taping |
| Temporary Felt Insoles | Active comparator | other will be given temporary shoe insoles. A temporary orthosis will be fabricated from 7-mm orthopedic felt. The orthosis consist of two parts, a medial longitudinal buttress and a navicular/sustentaculum tali pad. The medial longitudinal buttress will extend from the posterior calcaneus to the first metatarsal head and from the medial border of the foot to the bisection of the calcaneus and calcaneal recess will be cut out. A navicular/sustentaculum tali pad will extend from the sustentaculum tali to the cuneiform. Receives: Other: Temporary Felt Insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot And Ankle Ability Measure- FAAM
A self-report outcome tool that was created to evaluate physical function in people with foot and ankle-related disabilities. This Questionnare consists of 29 items which is subdivided into two sub-scales: the Foot and Ankle Ability Measure, Activities of Daily Living (ADL) Subscale having 21 items and the Foot and Ankle Ability Measure, Sports Subscale having 8 items.
Measured: 2 months
Numeric Pain Rating Scale- NPRS
It is an outcome measure that provides a one-dimensional assessment of pain severity. It is an 11-point numeric scale spans from "0" to "10," with "pain as awful as you can conceive" or "worst pain imaginable" denoting one extreme of pain and "no pain" denoting the other.
Measured: 2 months
Low Dye Taping Technique (To overcome pain and disability)
it is designed to off-load the plantar fascia and provide medial ankle arch support. It is a classic taping method incorporating functional mechanical support of the foot and ankle
Measured: 2 months
Temporary Felt Insoles (To overcome pain and disability)
the inner sole of a shoe or boot. a loose additional inner sole used to give extra warmth, comfort.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start15 Sep 2022
- Primary completion30 Mar 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pes PlanusStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnab Altaf, Mphill, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764967
- Sponsor's protocol ID
- REC/RCR&AHS/22/0746
- Status last verified
- Jul 2023
- First submitted
- 4 Jan 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects Of Low Dye Taping Technique And Temporary Felt Insoles On Pain And Disability In Children With Pes Planus
- ClinicalTrials.gov ID
- NCT05764967
- Acronym / sponsor ID
- REC/RCR&AHS/22/0746
- Conditions
- Pes Planus
- Keywords
- Disability, Insoles, Low Dye Taping, Pain, Pes Planus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 13 Mar 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.
This study aims to determine comparative effects of low dye taping technique and temporary felt insoles on pain and disability in children with pes planus.
Detailed description
Pes planus is a foot arch deformity, is also known as flexible flat foot. Foot arch plays an important role in cushioning ground impact and stabilizing the body in standing and walking. Children with pes planus lack an elastic foot arch to attenuate the impact force. This condition results in pain and impaired lower limb function. Low Dye taping and shoe insoles are used to treat Pes Planus. Low Dye taping technique is designed to off-load the plantar fascia and provide medial ankle arch support. It is a classic taping method incorporating functional mechanical support of the foot and ankle. Low-Dye taping is commonly used to support the longitudinal and transverse arches of the foot.
A shoe insole is the footbed or material inside the shoe that the bottom or plantar surface of your foot lays on. In most well-made shoes today, the material or insole is removable. There are shoes that have glued in insoles, however in general these are shoes that are not as well made. The removable insoles that come in most shoes vary in type and material ranging from very simple thin cushioning to sophisticated multiple layered arch support inserts. The aim of this study is to compare the effects of Low dye taping and shoe insoles on pain and disability in children with pes planus.
The study will be Randomized Clinical trial. Total twenty four subjects will be assigned randomly by using block randomization into two groups (12 in each group). Both Groups will be experimental groups. Group A will be given low dye taping and Group B would be given temporary felt insoles. After confirmation of diagnosis with medical history and physical examination as well as different movement palpation tests and pain provocation tests are recommended. The Foot and Ankle Ability Measure (FAAM) and Numeric Pain Rating Scale (NPR) would be used as an outcome measure tools for pain and disability respectively. Measure will be taken at (Baseline and at the end of treatment session). The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 27.0. Parametric/non-parametric tests will be applied after testing normality of data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dye Taping | Experimental | Other: Low Dye TapingOne Arm will be given Low Dye taping. The augmented low-Dye technique, involves applying a device consisting of a spur and mini-stirrups to the foot and then adding reverse sixes and calcaneal slings to an anchor on the distal one-third of the leg. A rigid 38-mm sports tape with zinc oxide adhesive will be used for all of the taping procedures. Prior to application of the tape, any hair in the region will be shaved and the foot and leg will be washed with soap and warm water to remove any dirt or oils that might decrease the adhesion of the tape. The Transverse Tibial Rotation (TTR) measurements will be repeated following application of tape. |
| Temporary Felt Insoles | Active comparator | Other: Temporary Felt Insolesother will be given temporary shoe insoles. A temporary orthosis will be fabricated from 7-mm orthopedic felt. The orthosis consist of two parts, a medial longitudinal buttress and a navicular/sustentaculum tali pad. The medial longitudinal buttress will extend from the posterior calcaneus to the first metatarsal head and from the medial border of the foot to the bisection of the calcaneus and calcaneal recess will be cut out. A navicular/sustentaculum tali pad will extend from the sustentaculum tali to the cuneiform. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6-12year
- vertical navicular height of 10 mm or more
- A Vernier height gauge (Mitutoyo Corp, Tokyo, Japan) calibrated to 0.02 mm was used to measure vertical navicular height.
Key exclusion criteria (2 listed)
- current injuries to the lower extremities that had required a reduction in activity levels and/or treatment by a health-care practitioner.
- severe orthopedic or neurologic conditions, and a known allergy to sports tape.
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 |
|---|---|---|
| Low Dye TapingThe augmented low-Dye technique, involves applying a device consisting of a spur and mini-stirrups to the foot and then adding reverse sixes and calcaneal slings to an anchor on the distal one-third of the leg. A rigid 38-mm sports tape with zinc oxide adhesive is used for all of the taping procedures. | Other | Low Dye Taping |
| Temporary Felt InsolesA temporary orthosis is fabricated from 7-mm orthopedic felt.The subject stands on his or her template while the TTR pointer is attached to the medial tibial plateau of the leg using a Velcro strap. An outline of the position of the device on the tibial plateau is drawn onto the skin with an indelible ink pen to allow for accurate relocation between all trials. TTR is measured in relaxed calcaneal stance while the subject wearing shoes. Measurements are recorded onto a data-collection sheet. Each measurement performes twice. The subject are given orthosis inserted into the shoe. All shoes are visually assessed to ensure that they will not induce pronation or internal rotation. | Other | Temporary Felt Insoles |
Primary outcome
Foot And Ankle Ability Measure- FAAM
Time frame: 2 months
A self-report outcome tool that was created to evaluate physical function in people with foot and ankle-related disabilities. This Questionnare consists of 29 items which is subdivided into two sub-scales: the Foot and Ankle Ability Measure, Activities of Daily Living (ADL) Subscale having 21 items and the Foot and Ankle Ability Measure, Sports Subscale having 8 items.
Numeric Pain Rating Scale- NPRS
Time frame: 2 months
It is an outcome measure that provides a one-dimensional assessment of pain severity. It is an 11-point numeric scale spans from "0" to "10," with "pain as awful as you can conceive" or "worst pain imaginable" denoting one extreme of pain and "no pain" denoting the other.
Low Dye Taping Technique (To overcome pain and disability)
Time frame: 2 months
it is designed to off-load the plantar fascia and provide medial ankle arch support. It is a classic taping method incorporating functional mechanical support of the foot and ankle
Temporary Felt Insoles (To overcome pain and disability)
Time frame: 2 months
the inner sole of a shoe or boot. a loose additional inner sole used to give extra warmth, comfort.
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 1 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Pes Planus
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Comparing Effects of Custom Foot Orthotic Intervention to Foot-Core Training Protocol on Lower Extremity Kinematics in Runners With Pes Planus
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Immediate Effects of Plantar Fascia Release Combined With Foot Exercises on FMS Subscores in Young Adults With Pes Planus
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Peripheral Magnetic Stimulation of Foot Muscles: Effects on Medial Longitudinal Arch Height and Foot Muscle Strength in Adults With Flat Feet
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Effects of Hip-Based Versus Knee-Based Exercises on Medial Longitudinal Arch, Dynamic Balance, and Muscle Strength in Flexible Flatfoot
Flexible Flatfoot, Flexible Flatfoot or Pes Planus
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.
Arnab Altaf, Mphill 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 Low Dye Taping and Temporary Felt Insoles in people with Pes Planus, 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 3 inclusion and 2 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 1 Aug 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?
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?
Foot And Ankle Ability Measure- FAAM (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.