History of Changes for Study: NCT05969210

Effects of Big Toe Strengthening on Agility, Jump and Speed Among Runners

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Version	A	B	Submitted Date	Changes
1			July 31, 2023	None (earliest Version on record)

Study Identification


Unique Protocol ID:	REC/RCR & AHS/23/0423 Aqsa
Brief Title:	Effects of Big Toe Strengthening on Agility, Jump and Speed Among Runners
Official Title:	Effects of Big Toe Strengthening on Agility, Jump and Speed Among Runners
Secondary IDs:

Study Status


Record Verification:	July 2023
Overall Status:	Completed
Study Start:	December 22, 2022
Primary Completion:	May 30, 2023 [Actual]
Study Completion:	June 30, 2023 [Actual]

First Submitted:	June 6, 2023
First Submitted that Met QC Criteria:	July 31, 2023
First Posted:	August 1, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	July 31, 2023
Last Update Posted:	August 1, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Riphah International University
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:

Study Description

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.

Detailed Description:

The objective of my study is to explore the effects of big toe strengthening on agility, jump and speed among runners.

Conditions


Conditions:	Sports Physical Therapy
Keywords:	Big toe Athlete Dynamometer Muscle Strength Agility

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Single (Participant)
Allocation:	Randomized
Enrollment:	24 [Actual]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Group A 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.	Toe strengthening exercise 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.
Experimental: Group B 12 participants will be in control group they will do only there running training.	Control Group 12 participants will be in control group they will do only there running training.

Outcome Measures


Primary Outcome Measures:
1.	HIP AND TOE DYNAMOMETER [ Time Frame: 3 weeks ] 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).
2.	Dynamic balance Y TEST, Star excursion test (SEBT) [ Time Frame: 3 weeks ] 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.	Vertical jumping, Horizontal jumping [ Time Frame: 3 weeks ] 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)
4.	STRENGHT • Speed: 20m Sprint test • Agility---- T- Test [ Time Frame: 3 weeks ] Ask the player to put the thumb on dynamometer and press it and see the strength.

Eligibility


Minimum Age:	16 Years
Maximum Age:	28 Years
Sex:	Male
Gender Based:	Yes
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria: Age; 16-28yrs Male runners Doing Running practice for 3 days in a week(40-60minutes per day) Exclusion Criteria: 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)

Contacts/Locations


Study Officials:	Aamir Gul Memon, MS Principal Investigator Riphah International University
Locations:	Pakistan, Punjab
	Pakistan Sports Board Lahore, Punjab, Pakistan, 5400

IPDSharing


Plan to Share IPD:	No

References


Citations:	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. PubMed 35800136
	Tufano JJ, Amonette WE. Assisted versus resisted training: which is better for increasing jumping and sprinting? Strength & Conditioning Journal. 2018;40(1):106-10.
	Horicka P, Simonek J, Brodani J. Diagnostics of reactive and running agility in young football players. Physical Activity Review. 2018;6:29-36.
	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.
	Angin S, Demirbüken İ. Ankle and foot complex. Comparative Kinesiology of the Human Body: Elsevier; 2020. p. 411-39.
	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-.
	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. PubMed 34972181
	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. PubMed 31380446
	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.
	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. PubMed 35594285
	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. PubMed 32173032
	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.
	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. PubMed 22837976
	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. PubMed 21509114
	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. PubMed 10726428
	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. PubMed 25226312
	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.
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