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Completed

NCT Number: NCT06479525

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Big Toe Flexor Strengthening Exercises

Other

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.

Calf Strengthening Exercises

Other

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2024
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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