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RecruitingNCT06296524Updated Mar 7, 2024

Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot

An interventional study of Footcore exercises and conventional therapy and conventional therapy in Flatfoot, sponsored by Maharishi Markendeswar University (Deemed to be University). Recruiting at 1 site in India. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by Maharishi Markendeswar University (Deemed to be University) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Flatfoot

Browse trials for

Keywords

  • Footcore, Harris Mat, Plantar pressure.
03

In context

Flatfoot

173 studies on the registry are indexed under Flatfoot; 44 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 122 interventional studies indexed under Flatfoot.

Browse Flatfoot studies →

Lead sponsor

Maharishi Markendeswar University (Deemed to be University) is the lead sponsor of 41 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Individuals having flat feet.
  2. those with a height difference of ≥ 10 mm during the navicular drop test.
  3. No history of foot or ankle surgery.

Exclusion criteria

Exclusion Criteria:

  1. Any lower limb injury
  2. Healing fracture of lower limb33
  3. Any neuromuscular disorder 25
  4. Recent surgery
  5. Any open wound.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Footcore exercises and conventional therapy

    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

    Other: Footcore exercises and conventional therapy

  • Active comparator
    Conventional Therapy

    Participants received conventional physiotherapy treatment, which includes toe curl, picking of small object, heel raise (For 4 weeks, twice a day).

    Other: conventional therapy

Interventions

  • OtherFootcore exercises and conventional therapy

    30 minutes exercises protocol will be provided

  • Otherconventional therapy

    conventional therapy will be provided.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month

  2. 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)

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Mar 2024, 0 months.

Of 89 non-industry interventional studies with no phase under Flatfoot, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 15. This study's 0 months is below that.

Counting every sponsor, half of 89 studies reached it within 7 months; a quarter within 2 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 29, 2024
First posted
Mar 6, 2024
StartActual
Mar 1, 2024
Primary completionActual
Mar 1, 2024
CompletionEst.
Mar 30, 2024
Last update
Mar 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06296524
Lead sponsor
Maharishi Markendeswar University (Deemed to be University)
Responsible party
Subhasish Chatterjee (Clinical Professor, Maharishi Markendeswar University (Deemed to be University)) — Principal investigator
First posted
Mar 6, 2024
Start date
Mar 1, 2024
Primary completion
Mar 1, 2024
Completion
Mar 30, 2024 (estimated)
Last update
Mar 7, 2024

Study contacts

Subhasish Chatterjee, Phd
Contact
subhasishphysio@mmumullana.org
+918950037407
Rakshya Pariyar
Contact
rakshyapariyar549@gmail.com
07082181581
Mousumi Saha, MPT
principal investigator · MMIPR

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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