NCT05969210

Brief Summary

Running form and technique have a direct influence on a runner's economy, and therefore small changes in specific running mechanics could be useful to improving running performance. The thumb plays an important role in the functionality of the foot. During standing, the big toe is more loaded than the head of the five metatarsals and the heel. The study design will be a Randomized Controlled Trial. This study will be conducted in Pakistan Sports Board (PSB) Lahore. The study will be completed within the time duration of eight to ten months after the approval of the synopsis. The sample size will be 30 subjects. Non-probability convenient sampling technique will be used to recruit the individuals for the study. Then randomization will be done by lottery method to divide the individuals into 2 treatment groups. The experimental group is given big toe strengthening program for 3 weeks along with running training on the other hand control group will do only their running training and after that measure their pre-post values on spss. In this study, it will be aimed to examine the relationship of big toe strength with parameters that affect anaerobic athletic performance in runners such as vertical jump, horizontally jumping, strength, agility and speed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

June 6, 2023

Last Update Submit

July 31, 2023

Conditions

Sports Physical Therapy

Keywords

Big toeAthleteDynamometerMuscle StrengthAgility

Outcome Measures

Primary Outcomes (4)

  • HIP AND TOE DYNAMOMETER

    Athletes will placed 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 asked to apply maximum force with their big toe. Strength measurements were made on the athletes in the sitting position without any support(6).

    3 weeks

  • Dynamic balance Y TEST, Star excursion test (SEBT)

    Y test reliability (ICC = 0.88- 0.99 (14) The reliability of the SEBT as being moderate to good (ICC 0.67- 0.97 )(14).

    3 weeks

  • Vertical jumping, Horizontal jumping

    puts chalk on their fingertips to mark the wall at the height of their jump. Then stands away from the wall, and jumps vertically as high as possible using both arms and legs to assist in projecting the body upwards. Attempt to touch the wall at the highest point of the jump(15)

    3 weeks

  • STRENGHT • Speed: 20m Sprint test • Agility---- T- Test

    Ask the player to put the thumb on dynamometer and press it and see the strength.

    3 weeks

Study Arms (2)

Group A

EXPERIMENTAL

12 participants will be in experimental group giving them Toe strengthening exercise protocol along with running training for three weeks, measure all values before giving them protocol and after protocol.

Other: Toe strengthening exercise

Group B

EXPERIMENTAL

12 participants will be in control group they will do only there running training.

Other: Control Group

Interventions

Toe strengthening exerciseOTHER

12 participants will be in experimental group giving them Toe strengthening exercise protocol along with running training for three weeks, measure all values before giving them protocol and after protocol.

Group A
Control GroupOTHER

12 participants will be in control group they will do only there running training.

Group B

Eligibility Criteria

Age16 Years - 28 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age; 16-28yrs
  • Male runners
  • Doing Running practice for 3 days in a week(40-60minutes per day)

You may not qualify if:

  • Participants a will be excluded if they have any neurological signs.
  • Any lower limb trauma and history of fracture past six month
  • Systematic illness ; diabetic ,hypertension(6)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Sports Board

Lahore, Punjab Province, 5400, Pakistan

Location

Related Publications (17)

  • Denadai BS, Greco CC. Could middle- and long-distance running performance of well-trained athletes be best predicted by the same aerobic parameters? Curr Res Physiol. 2022 Jun 23;5:265-269. doi: 10.1016/j.crphys.2022.06.006. eCollection 2022.

    PMID: 35800136BACKGROUND

  • Tufano JJ, Amonette WE. Assisted versus resisted training: which is better for increasing jumping and sprinting? Strength & Conditioning Journal. 2018;40(1):106-10.

    BACKGROUND

  • Horicka P, Simonek J, Brodani J. Diagnostics of reactive and running agility in young football players. Physical Activity Review. 2018;6:29-36.

    BACKGROUND

  • Stoneham R, Barry G, Saxby L, Wilkinson M. The influence of great toe valgus on pronation and frontal plane knee motion during running. The Foot and Ankle Online Journal. 2020;13(1):7.

    BACKGROUND

  • Angin S, Demirbüken İ. Ankle and foot complex. Comparative Kinesiology of the Human Body: Elsevier; 2020. p. 411-39.

    BACKGROUND

  • Sarikaya F, Sahin M. The Effect of Big Toe Strength Development on Some Athletic Performance Parameter in Young Male Footballers. Pakistan Journal of Medical & Health Sciences. 2022;16(02):997-.

    BACKGROUND

  • Kurihara T, Terada M, Numasawa S, Kusagawa Y, Maeo S, Kanehisa H, Isaka T. Effects of age and sex on association between toe muscular strength and vertical jump performance in adolescent populations. PLoS One. 2021 Dec 31;16(12):e0262100. doi: 10.1371/journal.pone.0262100. eCollection 2021.

    PMID: 34972181BACKGROUND

  • Sutkowska E, Sutkowski K, Sokolowski M, Franek E, Dragan S Sr. Distribution of the Highest Plantar Pressure Regions in Patients with Diabetes and Its Association with Peripheral Neuropathy, Gender, Age, and BMI: One Centre Study. J Diabetes Res. 2019 Jul 9;2019:7395769. doi: 10.1155/2019/7395769. eCollection 2019.

    PMID: 31380446BACKGROUND

  • Liang ZQ, Meng Y, Popik S, Chen FF, editors. Analysis of foot morphology in habitually barefoot group. Journal of Biomimetics, Biomaterials and Biomedical Engineering; 2019: Trans Tech Publ.

    BACKGROUND

  • Yamauchi J, Koyama K. The mechanical role of the metatarsophalangeal joint in human jumping. PLoS One. 2022 May 20;17(5):e0268634. doi: 10.1371/journal.pone.0268634. eCollection 2022.

    PMID: 35594285BACKGROUND

  • Yamauchi J, Koyama K. Importance of toe flexor strength in vertical jump performance. J Biomech. 2020 May 7;104:109719. doi: 10.1016/j.jbiomech.2020.109719. Epub 2020 Feb 26.

    PMID: 32173032BACKGROUND

  • Otsuka M, Yamauchi J, Kurihara T, Morita N, Isaka T. Toe flexor strength and lower-limb physical performance in adolescent. Gazzetta medica italiana. 2015;174(7-8):307-13.

    BACKGROUND

  • Shin H, Moon SW, Kim GS, Park JD, Kim JH, Jung MJ, Yoon CH, Lee ES, Oh MK. Reliability of the pinch strength with digitalized pinch dynamometer. Ann Rehabil Med. 2012 Jun;36(3):394-9. doi: 10.5535/arm.2012.36.3.394. Epub 2012 Jun 30.

    PMID: 22837976BACKGROUND

  • Plisky PJ, Gorman PP, Butler RJ, Kiesel KB, Underwood FB, Elkins B. The reliability of an instrumented device for measuring components of the star excursion balance test. N Am J Sports Phys Ther. 2009 May;4(2):92-9.

    PMID: 21509114BACKGROUND

  • Young W, Wilson G, Byrne C. Relationship between strength qualities and performance in standing and run-up vertical jumps. J Sports Med Phys Fitness. 1999 Dec;39(4):285-93.

    PMID: 10726428BACKGROUND

  • Dobbs CW, Gill ND, Smart DJ, McGuigan MR. Relationship between vertical and horizontal jump variables and muscular performance in athletes. J Strength Cond Res. 2015 Mar;29(3):661-71. doi: 10.1519/JSC.0000000000000694.

    PMID: 25226312BACKGROUND

  • Pauole K, Madole K, Garhammer J, Lacourse M, Rozenek R. Reliability and validity of the T-test as a measure of agility, leg power, and leg speed in college-aged men and women. The Journal of Strength & Conditioning Research. 2000;14(4):443-50.

    BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Aamir Gul Memon, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

August 1, 2023

Study Start

December 22, 2022

Primary Completion

May 30, 2023

Study Completion

June 30, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)