Pes PlanusNCT05354180
Comparison of Navicular Mobilization and Rigid Tape in Pes Planus
A study testing navicular mobilization, rigid tapping and Navicular Mobilization and Rigid Taping in people with Pes Planus, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- navicular mobilization, rigid tapping and Navicular Mobilization and Rigid Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2022to 5 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pes Planus
- Being tested
- navicular mobilization, rigid tapping, Navicular Mobilization and Rigid Taping
- Keywords
- pain, navicular mobilization, rigid tape, tibial torsion
- Medical subject headings
- Flatfoot, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
navicular mobilizationOther
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
rigid tappingOther
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 TapingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Other: Navicular Mobilization and Rigid Taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Feb 2023
- Study completion5 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pes PlanusStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354180
- Sponsor's protocol ID
- REC -01256 Samra Ismail
- Status last verified
- Feb 2023
- First submitted
- 25 Apr 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Navicular Mobilization and Rigid Tape in Pes Planus
- ClinicalTrials.gov ID
- NCT05354180
- Acronym / sponsor ID
- REC -01256 Samra Ismail
- Conditions
- Pes Planus
- Keywords
- pain, navicular mobilization, rigid tape, tibial torsion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 5 Feb 2023 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| navicular mobilization | Experimental | Other: navicular mobilizationPlantar 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 |
| rigid tapping | Experimental | Other: rigid tappingA 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| | Experimental | Other: Navicular Mobilization and Rigid TapingPlantar 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| navicular mobilizationPlantar 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 tappingA 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 TapingPlantar 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| |
Primary outcome
Numerical pain rating scale
Time frame: four weeks
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.
Time frame: four weeks
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
Time frame: four weeks
(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
Time frame: four weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Khalid, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing navicular mobilization, rigid tapping and Navicular Mobilization and Rigid Taping in people with Pes Planus, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical pain rating scale (time frame: four weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.