Comparative Effects of Big Toe Flexor and Calf Strengthening Exercises on Medial Arch in Athletes With Flat Foot

June 24, 2024 updated by: Riphah International University

Flexible flatfoot is common in young adults. One of its causes is the failure of dynamic stabilizers, which play an important role in the medial longitudinal arch support, and their appropriate function is necessary for the integrity of the lower extremity and the spine. The metatarsal phalangeal joint (MPJ) and its crossing toe flexor muscles (TFM) represent the link between the large energy generating leg extensor muscles and the ground. Asymptomatic flat foot deformity is associated with gastrocnemius muscle tightness and a higher prevalence of gastrocnemius and soleus tightness was found in female subjects compared with males.

The study will be a randomized clinical trial. The study will be conducted in Pakistan Sports Board (PSB) Lahore. The sample size will be calculated by convenience sampling technique. The inclusion criteria will be participants of age between eighteen and thirty years old. Both male and female participants will be included. Athletes involved in sports more than one year and with asymptomatic flexible flatfeet (NDT > 10mm) will be included. Navicular drop test, Foot function index questionnaire, arch height index, toe/hip dynamometer and vertical jump test will be the tools used for assessment and evaluation. Participants who meet the inclusion criteria will be divided into two groups. Baseline measures and eight-week assessment of navicular drop test and arch height index will be taken. Strength of toe flexors will be evaluated with toe dynamometer. Participants who will meet the inclusion criteria will be provided with ethical consent forms and after baseline assessments, exercise program will be guided. Group A will perform big toe flexor strengthening exercises in addition to the sports plan they already follow. Group B will be assigned with calf strengthening exercises in addition to the plan they are following. Eight-week intervention program will be provided that will include warm up, therapeutic exercises including toe raises, towel curls and therapeutic band exercises, and then cool down period that includes stretching exercises.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective of the study is to apply big toe flexor and calf muscles strengthening exercises and to compare the results to identify their influence on medial longitudinal arch in flexible flat foot athletes.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 5400
        • Pakistan Sports Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 18 and 30 years' old
  • Both male and female
  • Athletes involved in sports with more than one year
  • Athletes with asymptomatic flexible flatfoot (NDT > 10mm) (5)

Exclusion Criteria:

  • Congenital flatfoot
  • Athletes using foot orthoses
  • Any lower limb muscle injury or trauma in the past 6 months
  • Had undergone lower limb surgery
  • Had lower extremity deformities: pes cavus, pes equinus, hallux valgus with greater angle than 15°, or clubfoot.(5)
  • Had a sign of neurological deficit over the lower extremities.
  • Female subjects if they were pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
16 participants will be in experimental group giving them Big Toe flexor strengthening exercises protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol.
Other: Big Toe Flexor Strengthening Exercises
16 participants will be in experimental group A giving them Big Toe Flexor strengthening exercise protocol along with the sports training plan for eight weeks measuring all values before giving them protocol and after protocol.
Experimental: Group B
16 participants will be in experimental group giving them calf strengthening exercises protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol.
Other: Calf Strengthening Exercises
16 participants will be in experimental group B giving them calf strengthening exercises including towel curls and thera band exercises along with the sports training plan for eight weeks measuring all values before giving them protocol and after protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Navicular Drop Test
Time Frame: 8 weeks
Navicular Drop Test is done by asking the subjects to sit on a chair with their knee and ankle in 90 ͦ and the navicular tubercle of their foot was palpated and marked on its greatest prominence. The examiner then determined the neutral position of the subtalar joint and this position was used for measurement. Then, a card was used to measure and mark the vertical height of the navicular bone in the non-weight bearing position. The height of the navicular bone was measured again in a full weight bearing position and marked on the same card. The difference between the initial and the second heights of this bone was labeled as the "Navicular Drop" index. (7)
8 weeks
Foot Function Index
Time Frame: 8 weeks
A Revised - Foot Function Index - Short form questionnaire consisting of 34 items will be used. This questionnaire includes five subscales: pain, stiffness, difficulty, activity limitation and social issues. The cumulative score of all the subscales will be added and divided by five. The higher the score, the more limitation/pain/disability is present. (15)
8 weeks
Arch Height Index
Time Frame: 8 weeks
Arch height index is measured by dividing the dorsum height at 50%-foot length by the truncated foot length expressed. The truncated foot length is a distance between center of the first metatarsophalangeal joint to posterior calcaneus. The measurement can be done both in relaxed standing (weight bearing) and sitting (non-weight bearing) conditions. The good intra-rater reliability study in children aged six to 12 years (ICCs ranged from 0.84 to 0.87). (5)
8 weeks
Vertical Jump Test
Time Frame: 8 weeks
The athlete stands side on to a wall and reaches up with the hand closest to the wall. Keeping the feet flat on the ground, the point of the fingertips (covered with chalk) is marked or recorded. This is called the standing reach height. The athlete then stands away from the wall, and leaps vertically as high as possible using both arms and legs to assist in projecting the body upwards. The jumping technique can or cannot use a countermovement. Attempt to touch the wall at the highest point of the jump. The difference in distance between the standing reach height and the jump height is the score. The best of three attempts is recorded. (1)
8 weeks
Hip and Toe Dynamometer
Time Frame: 8 weeks
Athletes will place their feet on the ground prepared in accordance with the big toe and adjusted their big toes according to the location of the pinch meter. During the measurement, athletes will be asked to perform big toe flexion by applying maximum force with their big toe. Strength measurements were made on the athletes in the sitting position without any support.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Aamir Gul Memon, MS, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2023

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0488 Mannan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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