Sports Physical TherapyNCT06986681
Big Toe Muscles Strengthening Exercises With and Without Neuromuscular Training Among Runners
A study testing Big toe muscles strengthening exercises and Big toe muscles strengthening exercises with neuromuscular training in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The big toe in relation to the other toes is responsible for a much greater percentage of foot and body stabilization as well as forward propulsion. Big toe muscles play a very significant role in the toe off phase during the locomotion, increasing the final push off from the ground during activities like walking… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Big toe muscles strengthening exercises and Big toe muscles strengthening exercises with neuromuscular training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jul 2024to 15 Apr 2025
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-30 years.
- Only female participants.
- Middle distance runners with at least 1 year experience.
Who cannot join
- Participants with current or recent (< 6 months) lower extremity musculoskeletal symptoms, neurological or neuromuscular conditions, severe foot deformities (i.e. club foot or deformities that hinders the activities of daily living).
- Participants with history of trauma or surgical treatment of lower extremity or foot within 6 months.
- Female participants with pregnancy.
- Systemic illnesses: Diabetes and hypertension etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Big Toe Muscles Strengthening Exercises With and Without Neuromuscular Training on Speed, Agility and Power Among Runners
The big toe in relation to the other toes is responsible for a much greater percentage of foot and body stabilization as well as forward propulsion. Big toe muscles play a very significant role in the toe off phase during the locomotion, increasing the final push off from the ground during activities like walking, running and jumping. Also have a role in maintaining medial arch of the foot. Marked evidence shows that neuromuscular training programs are effective for improving measures of performance. Comprehensive neuromuscular training programs designed for young women may significantly increase power, strength, and neuromuscular control. So, this study will determine the effects of big toe muscles strengthening exercises with and without neuromuscular training among runners.
This study will be a randomized clinical trial conducted at Pakistan sports board and coaching center Lahore and runners club in Lahore. Only female runners aged between 18-30 years having at least 1 year experience will be recruited in study. The participants will be randomly divided by simple random sampling into two groups. One group will perform the big toe muscles strengthening exercises with neuromuscular training and the other group will perform the big toe muscles strengthening exercises without neuromuscular training. The effects of Strengthening exercises of both the groups will be accessed on speed, power and agility of runners. Toe strength will be accessed by toe-hip dynamometer, Speed by 30 m sprint test, power by vertical jump, and agility by T-drill agility test at the start, and at the end of study duration. Statistical analysis will be performed using SPSS-26 providing a comprehensive approach to investigate the effects of bio toe muscles strength with and without neuromuscular training on speed, agility and power among runners.
Read the detailed description
The main objective of the study is to apply the big toe muscles strengthening exercises with and without neuromuscular training and to compare the results to identify their influence on speed, agility and power among runners.
- Conditions
- Sports Physical Therapy
- Being tested
- Big toe muscles strengthening exercises, Big toe muscles strengthening exercises with neuromuscular training
- Keywords
- Big Toe, Dynamometer, Neuromuscular Training, Runners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Big toe muscles strengthening exercisesOther
16 Participants will be in experimental group giving them Big toe muscles strengthening exercises protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol
Big toe muscles strengthening exercises with neuromuscular trainingOther
16 Participants will be in experimental group giving them Big toe muscles strengthening exercises and neuromuscular training protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol.
| Study group | Role | What they receive |
|---|---|---|
| Big toe muscles strengthening exercises | Experimental | 16 Participants will be in experimental group giving them Big toe muscles strengthening exercises protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol. Receives: Other: Big toe muscles strengthening exercises |
| Big toe muscles strengthening exercises with neuromuscular training | Experimental | 16 Participants will be in experimental group giving them Big toe muscles strengthening exercises and neuromuscular training protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol. Receives: Other: Big toe muscles strengthening exercises with neuromuscular training |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 M sprint test
The test involves running a single maximum sprint over 30 meters, with the time recorded. A thorough warm up should be given, including some practice starts and accelerations. Start from a stationary position, with one foot in front of the other. The front foot must be on or behind the starting line. This starting position should be held for 2 seconds prior to starting, and no rocking movements are allowed. The tester should provide hints for maximizing speed (such as keeping low, driving hard with the arms and legs) and encourage them to continue running hard through the finish line. Two trials are allowed, and the best time is recorded to the nearest 2 decimal places. The timing starts from the first movement (if using a stopwatch) or when the timing system is triggered and finishes when the chest crosses the finish line and/or the finishing timing gate is triggered.
Measured: 8 weeks
T-drill agility test
Subjects are asked to sprint forwards 10 yards (9.14 m) from the start line to the first cone and touch the tip with their right hand, shuffle 5yards (4.57 m) left to the second cone and touch with their left hand, then shuffle 10 yards (9.14 m) to the right to the third cone and touch with their right, shuffle 5 yards (4.57 m) back left to the middle cone and touch with their left hand before finally run backwards to the start line. Time began upon subjects passing through the timing gates and stopped upon them passing through on return. The test will not be counted if the subject crosses one foot in front of the other while shuffling, fails to touch the base of the cones, or fails to face forward throughout the test. Take the best time of three successful trials.
Measured: 8 weeks
Vertical jump test
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 is marked or recorded. This is called the standing reach test. 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 counter movement. 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.
Measured: 8 weeks
Toe-Hip Dynamometer
The Toe-Hip Strength Dynamometer is a novel IFM dynamometer that has been recently developed for clinicians. Using this tool, the test is conducted similarly to the paper-grip test. This dynamometer is similarly made of a plastic card attached to a hanging scale. For the test, individuals press their toes onto the card as hard as possible without toe curl to resist the assessor pulling the card out, and a peak force output is provided once the card slides out. Although it is still difficult to conclusively isolate the IFM, this device has a lower cost and size compared to other methods and may be useful in clinical settings. Furthermore, the tool is designed for the measurement to occur in a closed-chain position, which is the functional position of the foot.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start30 Jul 2024
- Primary completion15 Mar 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Outcomes assessor
- Enrolment
- 32 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
- NCT06986681
- Sponsor's protocol ID
- REC/RCR&AHS/24/0453
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 34972181Yamauchi 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 32173032Xu J, Goss DD, Saliba SA. A Novel Intrinsic Foot Muscle Strength Dynamometer Demonstrates Moderate-To-Excellent Reliability and Validity. Int J Sports Phys Ther. 2023 Aug 1;18(4):997-1008. doi: 10.26603/001c.84310. eCollection 2023.
PubMed 37547834Caldemeyer LE, Brown SM, Mulcahey MK. Neuromuscular training for the prevention of ankle sprains in female athletes: a systematic review. Phys Sportsmed. 2020 Nov;48(4):363-369. doi: 10.1080/00913847.2020.1732246. Epub 2020 Feb 28.
PubMed 32067546Trowell D, Phillips E, Saunders P, Bonacci J. The relationship between performance and biomechanics in middle-distance runners. Sports Biomech. 2021 Dec;20(8):974-984. doi: 10.1080/14763141.2019.1630478. Epub 2019 Jul 31.
PubMed 31364954Denadai 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 35800136Kusagawa Y, Kurihara T, Maeo S, Sugiyama T, Kanehisa H, Isaka T. Associations between the size of individual plantar intrinsic and extrinsic foot muscles and toe flexor strength. J Foot Ankle Res. 2022 Mar 21;15(1):22. doi: 10.1186/s13047-022-00532-9.
PubMed 35313927Willemse L, Wouters EJM, Pisters MF, Vanwanseele B. Plantar intrinsic foot muscle activation during functional exercises compared to isolated foot exercises in younger adults. Physiother Theory Pract. 2024 Aug;40(8):1656-1668. doi: 10.1080/09593985.2023.2204947. Epub 2023 Apr 26.
PubMed 37126537Rowley M, Kurihara T, Ortiz-Weissberg D, Kulig K. Contributions of flexor hallucis longus and brevis muscles to isometric toe flexor force production. Acta Bioeng Biomech. 2023;25(1):91-99.
PubMed 38314582van Oeveren BT, de Ruiter CJ, Beek PJ, van Dieen JH. The biomechanics of running and running styles: a synthesis. Sports Biomech. 2024 Apr;23(4):516-554. doi: 10.1080/14763141.2021.1873411. Epub 2021 Mar 4.
PubMed 33663325
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Big Toe Muscles Strengthening Exercises With and Without Neuromuscular Training on Speed, Agility and Power Among Runners
- ClinicalTrials.gov ID
- NCT06986681
- Acronym / sponsor ID
- REC/RCR&AHS/24/0453
- Conditions
- Sports Physical Therapy
- Keywords
- Big Toe, Dynamometer, Neuromuscular Training, Runners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 23 May 2025 (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.
The big toe in relation to the other toes is responsible for a much greater percentage of foot and body stabilization as well as forward propulsion. Big toe muscles play a very significant role in the toe off phase during the locomotion, increasing the final push off from the ground during activities like walking, running and jumping. Also have a role in maintaining medial arch of the foot. Marked evidence shows that neuromuscular training programs are effective for improving measures of performance. Comprehensive neuromuscular training programs designed for young women may significantly increase power, strength, and neuromuscular control. So, this study will determine the effects of big toe muscles strengthening exercises with and without neuromuscular training among runners.
This study will be a randomized clinical trial conducted at Pakistan sports board and coaching center Lahore and runners club in Lahore. Only female runners aged between 18-30 years having at least 1 year experience will be recruited in study. The participants will be randomly divided by simple random sampling into two groups. One group will perform the big toe muscles strengthening exercises with neuromuscular training and the other group will perform the big toe muscles strengthening exercises without neuromuscular training. The effects of Strengthening exercises of both the groups will be accessed on speed, power and agility of runners. Toe strength will be accessed by toe-hip dynamometer, Speed by 30 m sprint test, power by vertical jump, and agility by T-drill agility test at the start, and at the end of study duration. Statistical analysis will be performed using SPSS-26 providing a comprehensive approach to investigate the effects of bio toe muscles strength with and without neuromuscular training on speed, agility and power among runners.
Detailed description
The main objective of the study is to apply the big toe muscles strengthening exercises with and without neuromuscular training and to compare the results to identify their influence on speed, agility and power among runners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Big toe muscles strengthening exercises | Experimental | Other: Big toe muscles strengthening exercises16 Participants will be in experimental group giving them Big toe muscles strengthening exercises protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol. |
| Big toe muscles strengthening exercises with neuromuscular training | Experimental | Other: Big toe muscles strengthening exercises with neuromuscular training16 Participants will be in experimental group giving them Big toe muscles strengthening exercises and neuromuscular training protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18-30 years.
- Only female participants.
- Middle distance runners with at least 1 year experience.
Key exclusion criteria (4 listed)
- Participants with current or recent (< 6 months) lower extremity musculoskeletal symptoms, neurological or neuromuscular conditions, severe foot deformities (i.e. club foot or deformities that hinders the activities of daily living).
- Participants with history of trauma or surgical treatment of lower extremity or foot within 6 months.
- Female participants with pregnancy.
- Systemic illnesses: Diabetes and hypertension etc.
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 |
|---|---|---|
| Big toe muscles strengthening exercises16 Participants will be in experimental group giving them Big toe muscles 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 muscles strengthening exercises |
| Big toe muscles strengthening exercises with neuromuscular training16 Participants will be in experimental group giving them Big toe muscles strengthening exercises and neuromuscular training protocol along with their normal sports training plan for eight weeks, measuring all values before giving them protocol and after protocol. | Other | Big toe muscles strengthening exercises with neuromuscular training |
Primary outcome
30 M sprint test
Time frame: 8 weeks
The test involves running a single maximum sprint over 30 meters, with the time recorded. A thorough warm up should be given, including some practice starts and accelerations. Start from a stationary position, with one foot in front of the other. The front foot must be on or behind the starting line. This starting position should be held for 2 seconds prior to starting, and no rocking movements are allowed. The tester should provide hints for maximizing speed (such as keeping low, driving hard with the arms and legs) and encourage them to continue running hard through the finish line. Two trials are allowed, and the best time is recorded to the nearest 2 decimal places. The timing starts from the first movement (if using a stopwatch) or when the timing system is triggered and finishes when the chest crosses the finish line and/or the finishing timing gate is triggered.
T-drill agility test
Time frame: 8 weeks
Subjects are asked to sprint forwards 10 yards (9.14 m) from the start line to the first cone and touch the tip with their right hand, shuffle 5yards (4.57 m) left to the second cone and touch with their left hand, then shuffle 10 yards (9.14 m) to the right to the third cone and touch with their right, shuffle 5 yards (4.57 m) back left to the middle cone and touch with their left hand before finally run backwards to the start line. Time began upon subjects passing through the timing gates and stopped upon them passing through on return. The test will not be counted if the subject crosses one foot in front of the other while shuffling, fails to touch the base of the cones, or fails to face forward throughout the test. Take the best time of three successful trials.
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 is marked or recorded. This is called the standing reach test. 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 counter movement. 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.
Toe-Hip Dynamometer
Time frame: 8 weeks
The Toe-Hip Strength Dynamometer is a novel IFM dynamometer that has been recently developed for clinicians. Using this tool, the test is conducted similarly to the paper-grip test. This dynamometer is similarly made of a plastic card attached to a hanging scale. For the test, individuals press their toes onto the card as hard as possible without toe curl to resist the assessor pulling the card out, and a peak force output is provided once the card slides out. Although it is still difficult to conclusively isolate the IFM, this device has a lower cost and size compared to other methods and may be useful in clinical settings. Furthermore, the tool is designed for the measurement to occur in a closed-chain position, which is the functional position of the foot.
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 23 May 2025.
- 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 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.
- Background: PubMed 37547834Xu J, Goss DD, Saliba SA. A Novel Intrinsic Foot Muscle Strength Dynamometer Demonstrates Moderate-To-Excellent Reliability and Validity. Int J Sports Phys Ther. 2023 Aug 1;18(4):997-1008. doi: 10.26603/001c.84310. eCollection 2023.
- Background: PubMed 32067546Caldemeyer LE, Brown SM, Mulcahey MK. Neuromuscular training for the prevention of ankle sprains in female athletes: a systematic review. Phys Sportsmed. 2020 Nov;48(4):363-369. doi: 10.1080/00913847.2020.1732246. Epub 2020 Feb 28.
- Background: PubMed 31364954Trowell D, Phillips E, Saunders P, Bonacci J. The relationship between performance and biomechanics in middle-distance runners. Sports Biomech. 2021 Dec;20(8):974-984. doi: 10.1080/14763141.2019.1630478. Epub 2019 Jul 31.
- 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.
- Background: PubMed 35313927Kusagawa Y, Kurihara T, Maeo S, Sugiyama T, Kanehisa H, Isaka T. Associations between the size of individual plantar intrinsic and extrinsic foot muscles and toe flexor strength. J Foot Ankle Res. 2022 Mar 21;15(1):22. doi: 10.1186/s13047-022-00532-9.
- Background: PubMed 37126537Willemse L, Wouters EJM, Pisters MF, Vanwanseele B. Plantar intrinsic foot muscle activation during functional exercises compared to isolated foot exercises in younger adults. Physiother Theory Pract. 2024 Aug;40(8):1656-1668. doi: 10.1080/09593985.2023.2204947. Epub 2023 Apr 26.
- Background: PubMed 38314582Rowley M, Kurihara T, Ortiz-Weissberg D, Kulig K. Contributions of flexor hallucis longus and brevis muscles to isometric toe flexor force production. Acta Bioeng Biomech. 2023;25(1):91-99.
- Background: PubMed 33663325van Oeveren BT, de Ruiter CJ, Beek PJ, van Dieen JH. The biomechanics of running and running styles: a synthesis. Sports Biomech. 2024 Apr;23(4):516-554. doi: 10.1080/14763141.2021.1873411. Epub 2021 Mar 4.
- 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 Big toe muscles strengthening exercises and Big toe muscles strengthening exercises with neuromuscular training 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 4 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 23 May 2025. 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?
30 M sprint test (time frame: 8 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 NCT06986681, which also lists 10 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 23 May 2025.