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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06296524
Other study ID # SPC-2022-09
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date March 30, 2024

Study information

Verified date February 2024
Source Maharishi Markendeswar University (Deemed to be University)
Contact Subhasish Chatterjee, Phd
Phone +918950037407
Email subhasishphysio@mmumullana.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date March 30, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 30 Years
Eligibility 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: 1. Any lower limb injury 2. Healing fracture of lower limb33 3. Any neuromuscular disorder 25 4. Recent surgery 5. Any open wound.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Footcore exercises and conventional therapy
30 minutes exercises protocol will be provided
conventional therapy
conventional therapy will be provided.

Locations

Country Name City State
India MMIPR Ambala Haryana

Sponsors (1)

Lead Sponsor Collaborator
Maharishi Markendeswar University (Deemed to be University)

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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