Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05764967
Other study ID # REC/RCR&AHS/22/0746
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2022
Est. completion date April 5, 2023

Study information

Verified date July 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date April 5, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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 is used for all of the taping procedures.
Temporary Felt Insoles
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.

Locations

Country Name City State
Pakistan Children Hospital Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 months
Primary 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. 2 months
Primary 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 2 months
Primary 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. 2 months
See also
  Status Clinical Trial Phase
Completed NCT02075853 - Outcomes of the Evans Calcaneal Lengthening Based on Bone Grafting Material
Completed NCT05579054 - Translation, Validity, and Reliability of the Foot Posture Index (FPI-6) - Turkish Version
Completed NCT05549063 - Effect of Different Exercise Approaches on Balance and Proprioception in Individuals With Pes Planus N/A
Completed NCT06010420 - The Effect of Using Medial Longitudinal Arch Supported Insoles on Jumping in Young Football Players N/A
Completed NCT06004271 - The Effect of Kinesio Taping on q Angle and Pes Planus in Children With Cerebral Palsy N/A
Active, not recruiting NCT06034600 - Effect of Augmented Low-dye* Taping and Exercise on Plantar Pressure, Navicular Drop and Foot Posture in Pes Planus N/A
Completed NCT04179591 - Effects of Exercise and Insole on Foot Posture, Plantar Force Distribution, and Balance in Individuals With Pes Planus N/A
Completed NCT05170698 - Management of Pes Planovalgus With Talocalcaneal Coalition ,Osteotomy vs Arthroereisis N/A
Completed NCT05420272 - Comparison of Lower Extremity Biomechanics,Core Endurance, and Performance in Pes Planus : A Controlled Study
Not yet recruiting NCT05836519 - Effects of Pes Planus on Quality of Life
Completed NCT03629938 - Evaluation and Classification of Foot Medial Longitudinal Arch Height in Adults
Completed NCT05774327 - Effect of Myofascial Release in Addition to Foot Core Exercises in Young Adults With Asymptomatic Flexible Pes Planus N/A
Completed NCT05788406 - Effects of Dynamic Balance Exercise on Flexible Pes Planus N/A
Completed NCT04810715 - Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis
Completed NCT05012488 - Comparison of the Effects of Morton's Neuroma on Foot Pressure Distribution and Gait Parameters in Pes Planus and Pes Cavus Patients
Completed NCT06022718 - Comparison of Kinesio-Taping and Rigid-Taping on Vertical Jump in Individuals With Pes Planus N/A
Active, not recruiting NCT04734899 - Foot Core Training in Individuals With Pes Planus N/A
Not yet recruiting NCT06238505 - Acute Efficacy of Exercises Applied With Xbox and Biodex Devices in Pes Planus" N/A
Active, not recruiting NCT05296850 - Immediate Effects of Kinesio Taping and Manual Release in Young Adults With Pes Planus N/A
Not yet recruiting NCT06251804 - Effectiveness of Short-Foot Exercises in Water and on Land in Pes Planus N/A