Sports Physical TherapyNCT05969210
Effects of Big Toe Strengthening on Agility, Jump and Speed Among Runners
A study testing Toe strengthening exercise in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Toe strengthening exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Dec 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 28 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age; 16-28yrs
- Male runners
- Doing Running practice for 3 days in a week(40-60minutes per day)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The objective of my study is to explore the effects of big toe strengthening on agility, jump and speed among runners.
- Conditions
- Sports Physical Therapy
- Being tested
- Toe strengthening exercise, Control Group
- Keywords
- Big toe, Athlete, Dynamometer, Muscle Strength, Agility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Control GroupOther
12 participants will be in control group they will do only there running training.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Toe strengthening exercise |
| Group B | Experimental | 12 participants will be in control group they will do only there running training. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start22 Dec 2022
- Primary completion30 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aamir Gul Memon, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969210
- Sponsor's protocol ID
- REC/RCR & AHS/23/0423 Aqsa
- Status last verified
- Jul 2023
- First submitted
- 6 Jun 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 35800136Tufano 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 34972181Sutkowska 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 31380446Liang 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 35594285Yamauchi 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 32173032Otsuka 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 22837976Plisky 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 21509114Young 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Big Toe Strengthening on Agility, Jump and Speed Among Runners
- ClinicalTrials.gov ID
- NCT05969210
- Acronym / sponsor ID
- REC/RCR & AHS/23/0423 Aqsa
- Conditions
- Sports Physical Therapy
- Keywords
- Big toe, Athlete, Dynamometer, Muscle Strength, Agility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Toe strengthening exercise12 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 B | Experimental | Other: Control Group12 participants will be in control group they will do only there running training. |
Who may qualify
- Ages
- 16 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age; 16-28yrs
- Male runners
- Doing Running practice for 3 days in a week(40-60minutes per day)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toe strengthening exercise12 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 | Group A |
| Control Group12 participants will be in control group they will do only there running training. | Other | Group B |
Primary outcome
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).
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).
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)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 35800136Denadai 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.
- BackgroundTufano JJ, Amonette WE. Assisted versus resisted training: which is better for increasing jumping and sprinting? Strength & Conditioning Journal. 2018;40(1):106-10.
- BackgroundHoricka P, Simonek J, Brodani J. Diagnostics of reactive and running agility in young football players. Physical Activity Review. 2018;6:29-36.
- BackgroundStoneham 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.
- BackgroundAngin S, Demirbüken İ. Ankle and foot complex. Comparative Kinesiology of the Human Body: Elsevier; 2020. p. 411-39.
- BackgroundSarikaya 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: PubMed 34972181Kurihara 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.
- Background: PubMed 31380446Sutkowska 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.
- BackgroundLiang 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: PubMed 35594285Yamauchi 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.
- Background: PubMed 32173032Yamauchi 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.
- BackgroundOtsuka 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aamir Gul Memon, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toe strengthening exercise in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIP AND TOE DYNAMOMETER (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05969210, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.