HealthyNCT05344586
The Effects of Hamstring Stretching With and Without Neural Load on Flexibility, Maximum Isometric Strength and Tibial Nerve Pressure Pain Threshold
A study testing Hamstring stretching program with neural load and Hamstring stretching program without neural load in people with Healthy, run by University of Jaén at 1 site in Spain.
Trial summary
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcala. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hamstring stretching program with neural load and Hamstring stretching program without neural load
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 22 Apr 2022to 28 Jul 2022
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects who do not perform hamstring stretches with neural load in their daily training routine
Who cannot join
- Elite athletes competing or preparing for competition
- Lower limb surgery
- Hamstring injury in the last year
- Neurological, rheumatologic and/or orthopedic pathological history of lower limbs.
- Other comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Neural Load on Hamstring Stretching Upon Range of Motion, Maximum Isometric Strength and Tibial Nerve Pressure Pain Threshold in Asymptomatic Patients
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcala. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. Healthy subjects will be recruited and divided into two groups randomly to perform a hamstring stretching program for two months.
One group will perform a stretch with neural load and the other without neural load, although both groups will stretch for the same amount of time, repetitions and subjective sensation.
Read more
Participants will be measured before and after performing their assigned stretch. Then, a new post-stretch measurement will be taken after two months, period during which the subjects will perform the stretching program on their own. Finally, subjects will be asked to quit the stretching program to take a final evaluation measurement after one month of follow-up.
The objective will be to evaluate the effects of stretching with and without neural load on hamstring flexibility (main variable), maximum isometric strength and tibial nerve pressure pain threshold.
- Conditions
- Healthy
- Being tested
- Hamstring stretching program with neural load, Hamstring stretching program without neural load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamstring stretching program with neural loadOther
Participants will perform a hamstring stretch with neural load on their dominant leg. They will stretch five days a week, carrying out two repetitions of one minute each, taking a thirty second break in between. The stretch will be performed in a standing position with their dominant leg on a surface at a mid-thigh height approximately, where their knee is not fully stretched and remains unlocked and their back is in a neutral position. Participants will be encouraged to keep a maximum stretching sensation without feeling any pain. To perform the stretch, different tension parameters will be added in the following order (the next parameter shall not be introduced until the previous one has been exhausted): ankle dorsiflexion, cervical and craniocervical flexion, and hip flexion.
Hamstring stretching program without neural loadOther
Participants will perform a hamstring stretch without neural load on their dominant leg. They will stretch five days a week, carrying out two repetitions of one minute each, taking a thirty second break in between. The stretch will be performed in a standing position with their dominant leg on a surface at a mid-thigh height approximately, where their knee is not fully stretched and remains unlocked and their back is in a neutral position. Participants will be encouraged to keep a maximum stretching sensation without feeling any pain. To perform the stretch, tension will be added by flexing their hip, keeping their ankle relaxed and their spine neutral.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Hamstring stretching program with neural load Receives: Other: Hamstring stretching program with neural load |
| Control group | Experimental | Hamstring stretching program without neural load Receives: Other: Hamstring stretching program without neural load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hamstring flexibility
measured with a goniometer. The subject remains in a supine position with both lower limbs extended. One examiner maintains a 90° hip flexion of the lower limb chosen for measurement, while the other examiner passively brings the knee to extension until a greater tissue resistance is noted or a feeling of discomfort is indicated by the subject. The knee extension is measured taking as reference the articular interline, the peroneal malleolus and the greater trochanter. The ankle remains in a relaxed position and the first examiner checks that no pelvic tilts occur while measuring.
It is determined whether the subject has hamstring retraction if he scores less than 160º.
Measured: Baseline, 2 months and 3 months after intervention commencement
Secondary outcomes (1)
Changes in maximum isometric hamstring strength
measured using a digital dynamometer. Participants are placed in a prone position on the stretcher with the lower limb chosen for measurement in a 90º knee flexion (position determined visually). The dynamometer is placed on the subject´s heel. Then, an increasing force towards the knee extension is applied for 3-5 seconds. Subjects must try to maintain this position without allowing the knee to extend. The measurement is taken when the subject begins to extend his knee. Three measurements are taken in the same position leaving 30 seconds of rest in between. Finally, the average of the three measurements is taken.
Measured: Baseline, 2 months and 3 months after intervention commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start22 Apr 2022
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Achalandabaso, University of Jaén
- Investigators
- Juan Mínguez, Principal investigator, University of Alcalá, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344586
- Sponsor's protocol ID
- CEIM/HU/2019/36
- Status last verified
- Jul 2022
- First submitted
- 15 Apr 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neural Load on Hamstring Stretching Upon Range of Motion, Maximum Isometric Strength and Tibial Nerve Pressure Pain Threshold in Asymptomatic Patients
- ClinicalTrials.gov ID
- NCT05344586
- Acronym / sponsor ID
- CEIM/HU/2019/36
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 25 Apr 2022 (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 study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcala. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. Healthy subjects will be recruited and divided into two groups randomly to perform a hamstring stretching program for two months.
One group will perform a stretch with neural load and the other without neural load, although both groups will stretch for the same amount of time, repetitions and subjective sensation.
Participants will be measured before and after performing their assigned stretch. Then, a new post-stretch measurement will be taken after two months, period during which the subjects will perform the stretching program on their own. Finally, subjects will be asked to quit the stretching program to take a final evaluation measurement after one month of follow-up.
The objective will be to evaluate the effects of stretching with and without neural load on hamstring flexibility (main variable), maximum isometric strength and tibial nerve pressure pain threshold.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Hamstring stretching program with neural loadHamstring stretching program with neural load |
| Control group | Experimental | Other: Hamstring stretching program without neural loadHamstring stretching program without neural load |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects who do not perform hamstring stretches with neural load in their daily training routine
Key exclusion criteria (5 listed)
- Elite athletes competing or preparing for competition
- Lower limb surgery
- Hamstring injury in the last year
- Neurological, rheumatologic and/or orthopedic pathological history of lower limbs.
- Other comorbidities
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 |
|---|---|---|
| Hamstring stretching program with neural loadParticipants will perform a hamstring stretch with neural load on their dominant leg. They will stretch five days a week, carrying out two repetitions of one minute each, taking a thirty second break in between. The stretch will be performed in a standing position with their dominant leg on a surface at a mid-thigh height approximately, where their knee is not fully stretched and remains unlocked and their back is in a neutral position. Participants will be encouraged to keep a maximum stretching sensation without feeling any pain. To perform the stretch, different tension parameters will be added in the following order (the next parameter shall not be introduced until the previous one has been exhausted): ankle dorsiflexion, cervical and craniocervical flexion, and hip flexion. | Other | Intervention group |
| Hamstring stretching program without neural loadParticipants will perform a hamstring stretch without neural load on their dominant leg. They will stretch five days a week, carrying out two repetitions of one minute each, taking a thirty second break in between. The stretch will be performed in a standing position with their dominant leg on a surface at a mid-thigh height approximately, where their knee is not fully stretched and remains unlocked and their back is in a neutral position. Participants will be encouraged to keep a maximum stretching sensation without feeling any pain. To perform the stretch, tension will be added by flexing their hip, keeping their ankle relaxed and their spine neutral. | Other | Control group |
Primary outcome
Changes in hamstring flexibility
Time frame: Baseline, 2 months and 3 months after intervention commencement
measured with a goniometer. The subject remains in a supine position with both lower limbs extended. One examiner maintains a 90° hip flexion of the lower limb chosen for measurement, while the other examiner passively brings the knee to extension until a greater tissue resistance is noted or a feeling of discomfort is indicated by the subject. The knee extension is measured taking as reference the articular interline, the peroneal malleolus and the greater trochanter. The ankle remains in a relaxed position and the first examiner checks that no pelvic tilts occur while measuring. It is determined whether the subject has hamstring retraction if he scores less than 160º.
1 secondary outcome
Changes in maximum isometric hamstring strength
Time frame: Baseline, 2 months and 3 months after intervention commencement
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 29 Jul 2022.
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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.
Juan Mínguez principal investigator
University of Alcalá, Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hamstring stretching program with neural load and Hamstring stretching program without neural load in people with Healthy, run by University of Jaén at 1 site in Spain.
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 1 inclusion and 5 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 29 Jul 2022. 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 Spain. 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?
Changes in hamstring flexibility (time frame: Baseline, 2 months and 3 months after intervention commencement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2022.