Low Dye Taping Technique and Temporary Felt Insoles on Pain and Disability in Children With Pes Planus.

NCT05764967 | Completed DMC

• 1 other identifier: REC/RCR&AHS/22/0746
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pes Planus

Keywords

Disability; Insoles; Low Dye Taping; Pain; Pes Planus

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

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.

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.

Other: Temporary Felt Insoles

Interventions

Low Dye Taping OTHER

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.

Low Dye Taping

Temporary Felt Insoles OTHER

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.

Temporary Felt Insoles

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• year
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Children Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Flatfoot; Pain

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnab Altaf, Mphill

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: March 13, 2023
• Study Start: September 15, 2022
• Primary Completion: March 30, 2023
• Study Completion: April 5, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)