FlatfootNCT06296524
Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot
A study testing Footcore exercises and conventional therapy and conventional therapy in people with Flatfoot, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
Trial summary
Pes Planus is a medical condition in which arch of the foot is flattened, causing the entire sole of the foot to contact the floor. For those with flat feet, footcore exercises might be an effective non-invasive therapy. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Flatfoot
- What is being tested?
- Footcore exercises and conventional therapy and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 1 Mar 2024to 30 Mar 2024
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals having flat feet.
- those with a height difference of ≥ 10 mm during the navicular drop test.
- No history of foot or ankle surgery.
Who cannot join
- Any lower limb injury
- Healing fracture of lower limb33
- Any neuromuscular disorder 25
- Recent surgery
- Any open wound.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
MMIPR
Ambāla, Haryana, 133207
Mousumi Saha, MPT, +919366787310, msaha0029@gmail.com
subhasish chatterjee, Phd(NEURO), +918950037407, subhasishphysio@gmail.com
About this study
Official title: Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot: A Pilot RCT
Pes Planus is a medical condition in which arch of the foot is flattened, causing the entire sole of the foot to contact the floor. For those with flat feet, footcore exercises might be an effective non-invasive therapy. Footcore exercises aim to strengthen the intrinsic foot muscles that maintain the foot arch, enhance foot function and reduce the risk of injury in persons with flatfoot.
Read the detailed description
A pilot, random research with 10 participants was undertaken. Two groups, Experimental group and Control group, were randomly selected among the subjects. Participant completed the informed consent form before the navicular drop test and Harris Mat was used to measure the foot pressure. Footcore exercises and conventional therapy was given for four weeks ,twice a day for 6 days. While the Control group just received conventional treatment, the Experimental group combined Footcore exercise with it. The data will be analyzed using SPSS 26.0 software.
- Conditions
- Flatfoot
- Being tested
- Footcore exercises and conventional therapy, conventional therapy
- Keywords
- Footcore, Harris Mat, Plantar pressure.
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Footcore exercises and conventional therapyOther
30 minutes exercises protocol will be provided
conventional therapyOther
conventional therapy will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Footcore exercises and conventional therapy | Experimental | Participants received Footcore exercises along with conventional therapy for 4 weeks, twice a day Footcore exercises includes toe yoga, toe spreads, foot doming, calf stretch, ball rolling. + conventional therapy Receives: Other: Footcore exercises and conventional therapy |
| Conventional Therapy | Active comparator | Participants received conventional physiotherapy treatment, which includes toe curl, picking of small object, heel raise (For 4 weeks, twice a day). Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Navicular Drop Test
A thick, white index card was used for the navicular drop test, which measured the navicular height. The card was positioned from the surface in a vertical position, passing the navicular bone, on the medial portion of the hindfoot, parallel to the subject's feet (kept in a subtalar neutral position). The floor was measured while sitting and standing, and the level of the navicular tubercle's highest point was marked on the card.An increased intra- (ICC = 0.73-0.96) and inter-rater reliability (ICC = 0.92) along with significant Pearson correlations to radiographic images (r = 0.89-0.92)
have been shown when the NDT was modified to address these issues using the Sit-to-Stand Navicular Drop Test (SSNDT) method with digital photographs.
Measured: 1 month
Harris Mat for Plantar Pressure Distribution
On a Harris-Beth mat, the patients' footprints were captured . Each foot's static imprint was captured while the body was supported by just half of its weight. The broadest region of the arch and the heel of each foot were measured, and the arch index and foot pressure for both feet were determined by dividing the former value by the latter, as explained by Staheli et al.Interrater and interrater reliability of the footprint parameters both revealed ICC values close to or greater than 0.9. Previous research found that the SI and CSI have great reliability (0.914-0.998)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2024
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlatfootStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhasish Chatterjee, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Mousumi Saha, MPT, Principal investigator, MMIPR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296524
- Sponsor's protocol ID
- SPC-2022-09
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot: A Pilot RCT
- ClinicalTrials.gov ID
- NCT06296524
- Acronym / sponsor ID
- SPC-2022-09
- Conditions
- Flatfoot
- Keywords
- Footcore, Harris Mat, Plantar pressure.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 6 Mar 2024 (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 is a medical condition in which arch of the foot is flattened, causing the entire sole of the foot to contact the floor. For those with flat feet, footcore exercises might be an effective non-invasive therapy. Footcore exercises aim to strengthen the intrinsic foot muscles that maintain the foot arch, enhance foot function and reduce the risk of injury in persons with flatfoot.
Detailed description
A pilot, random research with 10 participants was undertaken. Two groups, Experimental group and Control group, were randomly selected among the subjects. Participant completed the informed consent form before the navicular drop test and Harris Mat was used to measure the foot pressure. Footcore exercises and conventional therapy was given for four weeks ,twice a day for 6 days. While the Control group just received conventional treatment, the Experimental group combined Footcore exercise with it. The data will be analyzed using SPSS 26.0 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Footcore exercises and conventional therapy | Experimental | Other: Footcore exercises and conventional therapyParticipants received Footcore exercises along with conventional therapy for 4 weeks, twice a day Footcore exercises includes toe yoga, toe spreads, foot doming, calf stretch, ball rolling. + conventional therapy |
| Conventional Therapy | Active comparator | Other: conventional therapyParticipants received conventional physiotherapy treatment, which includes toe curl, picking of small object, heel raise (For 4 weeks, twice a day). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Individuals having flat feet.
- those with a height difference of ≥ 10 mm during the navicular drop test.
- No history of foot or ankle surgery.
Key exclusion criteria (5 listed)
- Any lower limb injury
- Healing fracture of lower limb33
- Any neuromuscular disorder 25
- Recent surgery
- Any open wound.
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 |
|---|---|---|
| Footcore exercises and conventional therapy30 minutes exercises protocol will be provided | Other | Footcore exercises and conventional therapy |
| conventional therapyconventional therapy will be provided. | Other | Conventional Therapy |
Primary outcome
Navicular Drop Test
Time frame: 1 month
A thick, white index card was used for the navicular drop test, which measured the navicular height. The card was positioned from the surface in a vertical position, passing the navicular bone, on the medial portion of the hindfoot, parallel to the subject's feet (kept in a subtalar neutral position). The floor was measured while sitting and standing, and the level of the navicular tubercle's highest point was marked on the card.An increased intra- (ICC = 0.73-0.96) and inter-rater reliability (ICC = 0.92) along with significant Pearson correlations to radiographic images (r = 0.89-0.92) have been shown when the NDT was modified to address these issues using the Sit-to-Stand Navicular Drop Test (SSNDT) method with digital photographs.
Harris Mat for Plantar Pressure Distribution
Time frame: 1 month
On a Harris-Beth mat, the patients' footprints were captured . Each foot's static imprint was captured while the body was supported by just half of its weight. The broadest region of the arch and the heel of each foot were measured, and the arch index and foot pressure for both feet were determined by dividing the former value by the latter, as explained by Staheli et al.Interrater and interrater reliability of the footprint parameters both revealed ICC values close to or greater than 0.9. Previous research found that the SI and CSI have great reliability (0.914-0.998)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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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.
Mousumi Saha, MPT principal investigator
MMIPR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Footcore exercises and conventional therapy and conventional therapy in people with Flatfoot, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Mar 2024. 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 India. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Subhasish Chatterjee, Phd (+918950037407, subhasishphysio@mmumullana.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Navicular Drop Test (time frame: 1 month). The study lists 2 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 7 Mar 2024.