NCT06296524

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

February 29, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

March 7, 2024

Status Verified

February 1, 2024

Enrollment Period

Same day

First QC Date

February 29, 2024

Last Update Submit

March 6, 2024

Conditions

Keywords

Footcore, Harris Mat, Plantar pressure.

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)

    1 month

Study Arms (2)

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

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).

Other: conventional therapy

Interventions

30 minutes exercises protocol will be provided

Footcore exercises and conventional therapy

conventional therapy will be provided.

Conventional Therapy

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Any lower limb injury
  • Healing fracture of lower limb33
  • Any neuromuscular disorder 25
  • Recent surgery
  • Any open wound.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MMIPR

Ambāla, Haryana, 133207, India

RECRUITING

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mousumi Saha, MPT

    MMIPR

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Subhasish Chatterjee, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 6, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2024

Study Completion

March 30, 2024

Last Updated

March 7, 2024

Record last verified: 2024-02

Locations