Proprioceptive DisordersNCT03875170
Proprioceptive Neuromuscular Facilitation in the Flexibility and Strength of Flexor Muscles and Hamstrings
A study testing Experimental in people with Proprioceptive Disorders, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial summary
Introduction: The loss of normal values of ROM due to the lack of flexibility and strength in the hip flexors, quadriceps and hamstrings in soccer players can cause a loss of mobility of the hip and knee joint. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Proprioceptive Disorders
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 12 Apr 2019to 20 Jun 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volleyball players
- Male
- From 18 to 30 years old
- Federated in the Royal Federation of Football of the Community of Madrid
- Not had any musculoskeletal injuries in the last 3 months.
Who cannot join
- Impossibility, for work or academic reasons, to comply with the requirements of the study (interventions and evaluations);
- Under pharmacological treatment
- Who are exercising a physiotherapy treatment parallel to the development of the study
- Not sign the informed consent document.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Intervention by Proprioceptive Neuromuscular Facilitation in the Flexibility and Strength of Flexor Muscles and Hamstrings, in Federated Football Players From 18 to 30 Years Old. A Randomized Clinical Trial.
Introduction: The loss of normal values of ROM due to the lack of flexibility and strength in the hip flexors, quadriceps and hamstrings in soccer players can cause a loss of mobility of the hip and knee joint. Proprioceptive neuromuscular facilitation is an active-assisted stretching technique used to improve flexibility and therefore the ranges of joint mobility.
Aim. To assess the effectiveness of an intervention by proprioceptive neuromuscular facilitation in the improvement of flexibility and strength in the hamstring, hip flexor and quadriceps musculature compared to conventional stretches in football players.
Read more
Study design. Randomized, multicentric, single-blind clinical study. Methods. The 30 players will be randomly assigned to the study groups: experimental (proprioceptive neuromuscular facilitation and static stretches) and control (static stretches). The treatment will last 6 weeks, with two sessions a week of 5 minutes each. The study variables will be the range of hip mobility (using goniometry), hamstring flexibility (using the EPR test, inclinometer) and the strength of hip flexors, quadriceps and hamstrings (through the RM test). A descriptive statistical analysis will be carried out calculating the main statistical characteristics and after calculating the normality of the sample (test Kolmogorov- Smirnov), the differences between evaluations in each group (t-student test) and the intra- and intersubject effect will be calculated (ANOVA of repeated measures).
Expected results. Improved hip mobility, hamstring flexibility and strength in hip flexors, quadriceps and hamstrings muscles.
- Conditions
- Proprioceptive Disorders
- Being tested
- Experimental, Control
- Keywords
- Proprioceptive Neuromuscular Facilitation, Range of motion, Stretching, Muscle strength, Randomized clinical trial
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called Proprioceptive neuromuscular facilitation
The technique will be carried out with the subjects in the positions of supine, prone and lateral position, for the flexor muscles of the hip, hamstrings and quadriceps, where the musculature and the joint to be treated will be taken to a range of functional mobility. The subject will be asked to perform an isometric contraction, with a series of 3 seconds for sustained contraction and a rest between contraction of 2 to 3 seconds after activating the Golgi apparatus, making an inhibition of the stimulus and bringing the joint and muscle to the highest possible range of motion without pain.
ControlOther
Also called Muscle stretching
The active stretching technique will be performed for the hip, quadriceps and hamstring flexors with a voluntary antagonist activation to relax the agonist muscle, holding the movement to be performed for 30 seconds to stimulate the neuromuscular spindle and produce a relaxation of the muscle fibers.
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive neuromuscular facilitation | Experimental | Each session will last 5 minutes for each subject, taking place two sessions a week, in a period of 6 weeks. The intervention will be made at the beginning of the training session. The technique will be carried out with the subjects in the positions of supine, prone and lateral position, for the flexor muscles of the hip, hamstrings and quadriceps, where the musculature and the joint to be treated will be taken to a range of functional mobility Receives: Other: Experimental |
| Muscle stretching | Active comparator | Each session will last 5 minutes for each subject, taking place two sessions a week, in a period of 6 weeks. The intervention will be made at the beginning of the training session. It will be done for the hip, quadriceps and hamstring muscles with a voluntary antagonist activation to relax the agonist muscle. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline flexibility of the hamstring muscles after treatment and at month
The measurement instrument to measure the flexibility of the hamstring muscles is the passive elevation of the straight leg with an inclinometer (model ISOMED, Inc., Portland, OR) to be placed on the tibia (as distal as possible). The physiotherapist will maintain the extension of the knee and the leg will be lifted by the evaluator to a hip flexion, until the subject indicates pain in the hamstring muscles, when the evaluator perceives hip flexion restriction or when a posterior pelvic tilt occurs. The contralateral knee of the subject will remain in extension. The unit of measurement of the test is the maximum angle read from the inclinometer at the point of maximum flexibility, in degrees, with the normative range of 75 to 80 degrees (the greater the degree of flexibility, the greater the flexibility).
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Secondary outcomes (2)
Change from baseline the range of motion of hip after treatment and at month
The range of motion of the hip will be evaluated using a universal long arm goniometer. The hip flexion will be measured with the goniometer as the deviation from the neutral zero position in which the lower extremity and the trunk are in the horizontal plane. The fixed arm of the goniometer will be aligned on the horizontal axis of the body, while the mobile arm of the goniometer will be aligned on the lateral midline of the thigh, placing the goniometer support axis on the greater trochanter. Hip adduction and hip abduction will be measured from the neutral zero position in which the longitudinal axis of the thigh is perpendicular to the transverse line through the anterior superior iliac spines of the pelvis. The contralateral leg will be hanging over the edge of the stretcher. The unit of measurement for this test is the grade, with a range of normative movement from 0 to 50 degrees (the higher the graduation, the greater the mobility of the hip).
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline strength of upper limbs after treatment and at month
The strength of upper limbs will be measured with the 1RM test. This test is defined as the maximum repetition with the heaviest load through a full range of motion. To calculate the 1 RM, the indirect relationship methods of lifting a submaximal load with a full range of motion to failure will be used. From this action a mathematical model related to the load and the number of repetitions until the failure will be made, obtaining a value of force. The unit of measurement of this evaluation is the kilogram (a higher value indicates a greater performance in the strength of lower limbs)
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start12 Apr 2019
- Primary completion15 May 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proprioceptive DisordersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875170
- Sponsor's protocol ID
- FNP
- Status last verified
- Jan 2020
- First submitted
- 10 Mar 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Intervention by Proprioceptive Neuromuscular Facilitation in the Flexibility and Strength of Flexor Muscles and Hamstrings, in Federated Football Players From 18 to 30 Years Old. A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03875170
- Acronym / sponsor ID
- FNP
- Conditions
- Proprioceptive Disorders
- Keywords
- Proprioceptive Neuromuscular Facilitation, Range of motion, Stretching, Muscle strength, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 14 Mar 2019 (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.
Introduction: The loss of normal values of ROM due to the lack of flexibility and strength in the hip flexors, quadriceps and hamstrings in soccer players can cause a loss of mobility of the hip and knee joint. Proprioceptive neuromuscular facilitation is an active-assisted stretching technique used to improve flexibility and therefore the ranges of joint mobility.
Aim. To assess the effectiveness of an intervention by proprioceptive neuromuscular facilitation in the improvement of flexibility and strength in the hamstring, hip flexor and quadriceps musculature compared to conventional stretches in football players.
Study design. Randomized, multicentric, single-blind clinical study. Methods. The 30 players will be randomly assigned to the study groups: experimental (proprioceptive neuromuscular facilitation and static stretches) and control (static stretches). The treatment will last 6 weeks, with two sessions a week of 5 minutes each. The study variables will be the range of hip mobility (using goniometry), hamstring flexibility (using the EPR test, inclinometer) and the strength of hip flexors, quadriceps and hamstrings (through the RM test). A descriptive statistical analysis will be carried out calculating the main statistical characteristics and after calculating the normality of the sample (test Kolmogorov- Smirnov), the differences between evaluations in each group (t-student test) and the intra- and intersubject effect will be calculated (ANOVA of repeated measures).
Expected results. Improved hip mobility, hamstring flexibility and strength in hip flexors, quadriceps and hamstrings muscles.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive neuromuscular facilitation | Experimental | Other: ExperimentalEach session will last 5 minutes for each subject, taking place two sessions a week, in a period of 6 weeks. The intervention will be made at the beginning of the training session. The technique will be carried out with the subjects in the positions of supine, prone and lateral position, for the flexor muscles of the hip, hamstrings and quadriceps, where the musculature and the joint to be treated will be taken to a range of functional mobility |
| Muscle stretching | Active comparator | Other: ControlEach session will last 5 minutes for each subject, taking place two sessions a week, in a period of 6 weeks. The intervention will be made at the beginning of the training session. It will be done for the hip, quadriceps and hamstring muscles with a voluntary antagonist activation to relax the agonist muscle. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volleyball players
- Male
- From 18 to 30 years old
- Federated in the Royal Federation of Football of the Community of Madrid
- Not had any musculoskeletal injuries in the last 3 months.
Key exclusion criteria (4 listed)
- Impossibility, for work or academic reasons, to comply with the requirements of the study (interventions and evaluations);
- Under pharmacological treatment
- Who are exercising a physiotherapy treatment parallel to the development of the study
- Not sign the informed consent document.
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 |
|---|---|---|
| ExperimentalAlso: Proprioceptive neuromuscular facilitationThe technique will be carried out with the subjects in the positions of supine, prone and lateral position, for the flexor muscles of the hip, hamstrings and quadriceps, where the musculature and the joint to be treated will be taken to a range of functional mobility. The subject will be asked to perform an isometric contraction, with a series of 3 seconds for sustained contraction and a rest between contraction of 2 to 3 seconds after activating the Golgi apparatus, making an inhibition of the stimulus and bringing the joint and muscle to the highest possible range of motion without pain. | Other | Proprioceptive neuromuscular facilitation |
| ControlAlso: Muscle stretchingThe active stretching technique will be performed for the hip, quadriceps and hamstring flexors with a voluntary antagonist activation to relax the agonist muscle, holding the movement to be performed for 30 seconds to stimulate the neuromuscular spindle and produce a relaxation of the muscle fibers. | Other | Muscle stretching |
Primary outcome
Change from baseline flexibility of the hamstring muscles after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
The measurement instrument to measure the flexibility of the hamstring muscles is the passive elevation of the straight leg with an inclinometer (model ISOMED, Inc., Portland, OR) to be placed on the tibia (as distal as possible). The physiotherapist will maintain the extension of the knee and the leg will be lifted by the evaluator to a hip flexion, until the subject indicates pain in the hamstring muscles, when the evaluator perceives hip flexion restriction or when a posterior pelvic tilt occurs. The contralateral knee of the subject will remain in extension. The unit of measurement of the test is the maximum angle read from the inclinometer at the point of maximum flexibility, in degrees, with the normative range of 75 to 80 degrees (the greater the degree of flexibility, the greater the flexibility).
2 secondary outcomes
Change from baseline the range of motion of hip after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Change from baseline strength of upper limbs after treatment and at month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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 27 Jan 2020.
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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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Proprioceptive Disorders, run by Investigación en Hemofilia y Fisioterapia 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 5 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 27 Jan 2020. 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?
Change from baseline flexibility of the hamstring muscles after treatment and at month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 27 Jan 2020.