NCT05354180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

April 25, 2022

Last Update Submit

February 20, 2023

Conditions

Keywords

painnavicular mobilizationrigid tapetibial torsion

Outcome Measures

Primary Outcomes (4)

  • 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.

    four weeks

  • 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.

    four weeks

  • 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.

    four weeks

  • 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.

    four weeks

Study Arms (3)

navicular mobilization

EXPERIMENTAL

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

Other: navicular mobilization

rigid tapping

EXPERIMENTAL

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.

Other: rigid tapping

Navicular Mobilization and Rigid Taping|

EXPERIMENTAL

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.

Other: Navicular Mobilization and Rigid Taping

Interventions

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

navicular mobilization

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.

rigid tapping

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.

Navicular Mobilization and Rigid Taping|

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zobia School for special children

Mirpur, KPK, 25000, Pakistan

Location

MeSH Terms

Conditions

FlatfootPain

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

April 29, 2022

Study Start

April 1, 2022

Primary Completion

February 1, 2023

Study Completion

February 5, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations