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Comparison of Navicular Mobilization and Rigid Tape in Pes Planus

Primary Purpose

Pes Planus

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
navicular mobilization
rigid tapping
Navicular Mobilization and Rigid Taping
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 pain, navicular mobilization, rigid tape, tibial torsion

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with neuromuscular disorders level I, II and III according to gross motor function classification system
  • Positive Navicular Drop (navicular drop test) less than ≥ 10 mm

Exclusion Criteria:

  • Other deformities of foot.
  • Overweight and obesity.
  • Any recent lower limb injury in past 6 months.
  • Any fracture in last 6 months.
  • Taken any pain killer injection..
  • Any recent lower limb surgery in past 6 months.
  • Myopathies

Sites / Locations

  • Zobia School for special children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

navicular mobilization

rigid tapping

Navicular Mobilization and Rigid Taping|

Arm Description

Plantar glide combined with rotation of navicular bone against the talus The glide will be given in 20 repetitions of 3 sets, for 5 days a week

A non-elastic zinc oxide sports tape will be applied to patients. Patient will be advised to protect the tape from getting wet. Tape will be changed on every 3rd day (48 hours) on Wednesday and Friday.

Plantar glide combined with rotation of navicular bone against the talus The glide will be given in 20 repetitions of 3 sets, for 5 days a week. A non-elastic zinc oxide sports tape will be applied to patients. Patient will be advised to protect the tape from getting wet. Tape will be changed on every 3rd day (48 hours) on Wednesday and Friday.

Outcomes

Primary Outcome Measures

Numerical pain rating scale
a 11 point outcome measure used to measure the intensity of pain ranging from 0 (no pain) to 10 (worst imaginable pain(23), it has been exhibited moderate reliability (Intra class correlation coefficient (ICC) is a widely used reliability index) is 0.67. Assessment to be done at baseline and at end of every week.
Time up & go test.
used to asses functional mobility and balance in which subject rise from a chair, walk 3 meter or 10 feet , turn around, return to the chair, and sit down.the performance is graded based on whether the individual completes the test under 10 sec(independent), under 20 sec(independent for main transfers) and under 30 sec (require assistance).It has good to excellent reliability results with intraclass correlation coefficients ICC range,0.69-.99.Assessment to be done at baseline and at end of every week.
Goniometer
(tool used by health professionals to objectively measure the range of motion of each joint effectively). The data analysis demonstrated that the goniometer has high intertester reliability with ICC ranges from 0.98-0.99. Assessment to be done at baseline and at end of every week.
Navicular drop test
The navicular drop test is a measure to evaluate the function of the medial longitudinal arch, which is important for examination of patients with overuse injuries It evaluates the foot hyper pronation by first measuring the navicular tuberosity height from floor or supporting surface in seated position and then in full weight bearing position by placing an index card at medial aspect of foot and then measuring the difference between the two marks of navicular level in millimeters. This procedure was performed bilaterally and navicular drop values greater than 10 mm are considered to be hyper pronation(22).It has high intraclass correlation coefficients reported for both intertester and intratester reliability ranging from 0.78 to 0.83. Assessment to be done at baseline and at end of every week.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2022
Last Updated
February 20, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05354180
Brief Title
Comparison of Navicular Mobilization and Rigid Tape in Pes Planus
Official Title
Comparison of Navicular Mobilization and Rigid Tape in Pes Planus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 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
Pes planus, sometimes known as flat feet, is one of these disorders and is characterized by a collapsed medial longitudinal arch, hindfoot eversion, and forefoot abduction. Pes planus is a musculoskeletal condition that causes hip, knee, and foot discomfort. According to a descriptive cross-sectional survey, 17% of school-aged children, 64% men and 34% females have flat foot deformity. Talonavicular joint is responsible for translating inversion and eversion movements of the foot. Mobilization of the Talonavicular joint helps in the improvement of joint dysfunction caused by inappropriate or bad posture via the proprioceptors. Rigid tape also known as low dye tape is defined as non-elastic zinc oxide tape used by physical therapists to stabilize a joint and limit movement. The conventional rigid tape is frequently used with non-contractile tissue, which then acts similarly to a ligament to limit joint mobility and prevent joints from moving into dangerous or end range positions.
Detailed Description
Foot disorders are very frequent in elder adults, with some illnesses having a prevalence of up to 65 percent. Foot diseases and accompanying symptoms have been linked to a variety of negative health outcomes, including falls and functional restrictions. The biomechanics of many foot problems, however, are yet unknown. Foot biomechanics during functional activities, such as walking could play a role in the onset and progression of foot problems. Pes planus, sometimes known as flat feet, is one of these disorders and is characterized by a collapsed medial longitudinal arch, hindfoot eversion, and forefoot abduction. Pes planus is a musculoskeletal condition that causes hip, knee, and foot discomfort. Pes planus is a common deformity that affects newborns and children and normally goes away by the time they reach puberty. After that, the incidence tends to drop with age, with just 4% of children having flatfoot by the age of ten. This backs up the assumption that flatfoot in children normally resolves on its own throughout the first ten years of life. Pes planus is divided into two types: flexible (functional) and rigid (structural). The initial treatment of painful-but-flexible flatfoot is nonoperative. Conservative therapy techniques such as rest, icing, massage, and nonsteroidal anti inflammatory medication, should always be used initially to reduce pain in symptomatic flexible and rigid flatfeet. Physical therapy plan which includes electrotherapy, Achilles' tendon stretching , strengthening of calf muscles, intrinsic muscles of the foot, and navicular mobilization are used as treatment options. Talo-navicular joint is responsible for translating inversion and eversion movements of the foot. Mobilization of the talo-navicular joint helps in the improvement of joint dysfunction caused by inappropriate or bad posture via the proprioceptors. Rigid tape also known as low dye tape(18) is defined as non-elastic zinc oxide tape used by physical therapists to stabilize a joint and limit movement. The conventional rigid tape is frequently used with non-contractile tissue, which then acts similarly to a ligament to limit joint mobility and prevent joints from moving into dangerous or end range positions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pes Planus
Keywords
pain, navicular mobilization, rigid tape, tibial torsion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
navicular mobilization
Arm Type
Experimental
Arm Description
Plantar glide combined with rotation of navicular bone against the talus The glide will be given in 20 repetitions of 3 sets, for 5 days a week
Arm Title
rigid tapping
Arm Type
Experimental
Arm Description
A non-elastic zinc oxide sports tape will be applied to patients. Patient will be advised to protect the tape from getting wet. Tape will be changed on every 3rd day (48 hours) on Wednesday and Friday.
Arm Title
Navicular Mobilization and Rigid Taping|
Arm Type
Experimental
Arm Description
Plantar glide combined with rotation of navicular bone against the talus The glide will be given in 20 repetitions of 3 sets, for 5 days a week. A non-elastic zinc oxide sports tape will be applied to patients. Patient will be advised to protect the tape from getting wet. Tape will be changed on every 3rd day (48 hours) on Wednesday and Friday.
Intervention Type
Other
Intervention Name(s)
navicular mobilization
Intervention Description
Plantar glide combined with rotation of navicular bone against the talus The glide will be given in 20 repetitions of 3 sets, for 5 days a week
Intervention Type
Other
Intervention Name(s)
rigid tapping
Intervention Description
A non-elastic zinc oxide sports tape will be applied to patients. Patient will be advised to protect the tape from getting wet. Tape will be changed on every 3rd day (48 hours) on Wednesday and Friday.
Intervention Type
Other
Intervention Name(s)
Navicular Mobilization and Rigid Taping
Intervention Description
Plantar glide combined with rotation of navicular bone against the talus The glide will be given in 20 repetitions of 3 sets, for 5 days a week. A non-elastic zinc oxide sports tape will be applied to patients. Patient will be advised to protect the tape from getting wet. Tape will be changed on every 3rd day (48 hours) on Wednesday and Friday.
Primary Outcome Measure Information:
Title
Numerical pain rating scale
Description
a 11 point outcome measure used to measure the intensity of pain ranging from 0 (no pain) to 10 (worst imaginable pain(23), it has been exhibited moderate reliability (Intra class correlation coefficient (ICC) is a widely used reliability index) is 0.67. Assessment to be done at baseline and at end of every week.
Time Frame
four weeks
Title
Time up & go test.
Description
used to asses functional mobility and balance in which subject rise from a chair, walk 3 meter or 10 feet , turn around, return to the chair, and sit down.the performance is graded based on whether the individual completes the test under 10 sec(independent), under 20 sec(independent for main transfers) and under 30 sec (require assistance).It has good to excellent reliability results with intraclass correlation coefficients ICC range,0.69-.99.Assessment to be done at baseline and at end of every week.
Time Frame
four weeks
Title
Goniometer
Description
(tool used by health professionals to objectively measure the range of motion of each joint effectively). The data analysis demonstrated that the goniometer has high intertester reliability with ICC ranges from 0.98-0.99. Assessment to be done at baseline and at end of every week.
Time Frame
four weeks
Title
Navicular drop test
Description
The navicular drop test is a measure to evaluate the function of the medial longitudinal arch, which is important for examination of patients with overuse injuries It evaluates the foot hyper pronation by first measuring the navicular tuberosity height from floor or supporting surface in seated position and then in full weight bearing position by placing an index card at medial aspect of foot and then measuring the difference between the two marks of navicular level in millimeters. This procedure was performed bilaterally and navicular drop values greater than 10 mm are considered to be hyper pronation(22).It has high intraclass correlation coefficients reported for both intertester and intratester reliability ranging from 0.78 to 0.83. Assessment to be done at baseline and at end of every week.
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with neuromuscular disorders level I, II and III according to gross motor function classification system Positive Navicular Drop (navicular drop test) less than ≥ 10 mm Exclusion Criteria: Other deformities of foot. Overweight and obesity. Any recent lower limb injury in past 6 months. Any fracture in last 6 months. Taken any pain killer injection.. Any recent lower limb surgery in past 6 months. Myopathies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Khalid, MSOMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zobia School for special children
City
Mirpur
State/Province
KPK
ZIP/Postal Code
25000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Navicular Mobilization and Rigid Tape in Pes Planus

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