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

Primary Purpose

Pes Planus

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Low Dye Taping
Temporary Felt Insoles
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pes Planus focused on measuring Disability, Insoles, Low Dye Taping, Pain, Pes Planus

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children Hospital Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Dye Taping

Temporary Felt Insoles

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.
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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
July 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05764967
Brief Title
Low Dye Taping Technique and Temporary Felt Insoles on Pain and Disability in Children With Pes Planus.
Official Title
Comparative Effects Of Low Dye Taping Technique And Temporary Felt Insoles On Pain And Disability In Children With Pes Planus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
April 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pes Planus
Keywords
Disability, Insoles, Low Dye Taping, Pain, Pes Planus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dye Taping
Arm Type
Experimental
Arm Description
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.
Arm Title
Temporary Felt Insoles
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low Dye Taping
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Temporary Felt Insoles
Intervention Description
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.
Primary Outcome Measure Information:
Title
Foot And Ankle Ability Measure- FAAM
Description
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.
Time Frame
2 months
Title
Numeric Pain Rating Scale- NPRS
Description
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.
Time Frame
2 months
Title
Low Dye Taping Technique (To overcome pain and disability)
Description
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
Time Frame
2 months
Title
Temporary Felt Insoles (To overcome pain and disability)
Description
the inner sole of a shoe or boot. a loose additional inner sole used to give extra warmth, comfort.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnab Altaf, Mphill
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children Hospital Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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