FlexibilityNCT04026646
The Effects of Proprioceptive Neuromuscular Facilitation and Static Stretching Exercises
A study testing Proprioceptive Neuromuscular Facilitation stretching exercise and Static stretching exercise in people with Flexibility, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
Trial summary
In this randomized trial, the aim of study is compare acute and chronic effect of Proprioceptive Neuromuscular Facilitation stretching and static stretching in individuals with shortness hamstring in proprioception and performance. Read more about this study
- Who is it for?
- Ages 20 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Flexibility
- What is being tested?
- Proprioceptive Neuromuscular Facilitation stretching exercise and Static stretching exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jul 2019to 8 Mar 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 20 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being between 20-29 years of age,
- Male individuals,
- Individuals who have not participated in physical activity for the last 6 months,
- Who have the knee extension angle more than 20⁰,
- Who accept the conditions of the study and sign the written informed consent form.
Who cannot join
- Patients who have lower extremity injuries in the last 6 months,
- Who have visual or vestibular impairments except of refractive problems,
- Who have traumatic problems, who have rheumatologic, orthopedic or neuromuscular disease, Black people (due to muscle structure).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Eastern Mediterranean University
Mersin, 33010
Ece Mani, MPT, 03926303067 ext. 05488219691, ece.mani13@gmail.com
Berkiye Kırmızıgil, DPT, 03926303067, berkiye.kirmizigil@emu.edu.tr
About this study
Official title: The Effects of Proprioceptive Neuromuscular Facilitation and Static Stretching Exercises on Proprioceptive Sensation and Performance
In this randomized trial, the aim of study is compare acute and chronic effect of Proprioceptive Neuromuscular Facilitation stretching and static stretching in individuals with shortness hamstring in proprioception and performance. The primary outcome measurement is proprioception (position sense and motion sense), the secondary outcome measurements are physical performance evaluations.
All exercises will be performed by the same physiotherapist in 8 weeks and 3 times a week. Exercises will be performed bilaterally and data from the dominant lower extremity will be used in the analysis. Exercises and assessments to reduce the effects of circadian variation will be performed at the same times during the research.
Read the detailed description
Joint proprioception can be defined as the body's ability to determine position and detection movement without vision perception. Proprioception is provided from the stimulation of specialized nerve endings and mechanoreceptors located in and around the joints, such as muscles, tendons, fascia, joint capsule, and ligaments. The muscle spindle and golgi tendon organ are the most important receptors involved in the proprioceptive sensation of the knee joint.
In the literature, there are studies have investigated the effect of static stretching exercises on the sense of position. Some of these studies showed an improvement on position sense, while one study showed no effect. There are a limited number of studies have investigated the effects of Proprioceptive Neuromuscular Facilitation (PNF) stretching techniques on proprioceptive senses. However, the effects of static stretching and PNF stretching on kinesthesia have not been studied.
The aim of this study is to compare acute and chronic effect of PNF stretching and static stretching in individuals with shortness hamstring in proprioception and performance.
Hypothesis of research
H01: The acute effects of static stretching and PNF stretching exercises on the results of proprioceptive sensation are similar.
H02: The chronic effects of static stretching and PNF stretching exercises on the results of proprioceptive sensation are similar.
H03: The acute effects of static stretching and PNF stretching exercises on the results of physical performance are similar.
H04: The chronic effects of static stretching and PNF stretching exercises on the results of physical performance are similar.
The Universe and Sample of the Research:
A sample size calculation was performed using the G* Power software (version 3.1.9.2), taking into account the statistical tests to be used in the analyses, and the conventional effect size values proposed by Cohen. It was estimated that 27 subjects would be needed in each group (α=0.05, β=0.20, and Cohen d=0.8) in order to detect statistically significant difference in a Mann Whitney U test. Considering the samples that could not complete the study, this first sample size was increased by 10% and the final sample size was calculated as 30 in each group.
Methods:
The study will include volunteer sedentary male subjects aged between 20-29 years. The study will be carried out in the athlete's lab of the Eastern Mediterranean University.
Participants in the study who have signed a voluntary consent form will be informed about the study. Then, the evaluation starts with the socio-demographic data of the participants (age, gender, height, weight, dominant side). Evaluations will be performed as knee extension angle, proprioceptive sense, flexibility assessment, balance, explosive power tests and muscle strength assessment. Individuals will be divided into two groups by minimization randomization method. 30 seconds contract-relax-antagonist-contract method (CRAC) of Proprioceptive Neuromuscular Facilitation stretching exercises for hamstring muscle will be performed to Group 1 and 30 seconds static stretching exercises for hamstring muscle will be performed to Group 2.
To assess the acute effect, exercise will be performed after the first assessment and then all assessments will be repeated. To investigate the chronic effect, all exercises will be performed in 8 weeks and 3 times a week. After 6 weeks follow-up period, all participants will be evaluated again.
Evaluations in the Research
Knee Extension Test:
The individual's hip will be stabilized at 90 degrees flexion with 1 hand supporting the subject's distal thigh and the other hand cupping the heel. Physiotherapist passively extended the knee until the individual feels mild tension in hamstring muscle. At this point, it will measured the angle using a goniometer. Full knee extension would be equivalent to an angle of 180°. The angle missing from the full knee extension will be recorded as 'degree'.
Proprioceptive Sensory Measurements:
Isokinetic dynamometer will be used to evaluate the knee joint proprioceptive sense of subjects. The subjects will placed in a 90° hip flexion sitting position. Subjects will be informed about the tests. Before the test, a trial will be performed. Between the three tests 30 seconds rest period will be given. The difference between the target angle and the measured angle will be registered as absolute error. Averages of three measurements will be analyzed.
For motion sense measurements, 10° knee flexion position was selected for kinesthesia measurements. The subjects will be instructed to press the dynamometer lock button as soon as they will perceive any movement in the knee joint. 45° knee flexion position will be used in the measurement of position sense. The knee will be started in the 90° flexion position and before the test, target knee position will be taught during 5 seconds. Afterwards, the knee will be placed to starting position. Subjects will be asked to push the warning button as soon as they feel they will reach the target angle.
Room temperature will be kept at 25°C during the tests. Air splints will be used to eliminate the tactile sense. While care will be taken to preserve the silence of the environment, subjects will be dressed in headphones at the same time to prevent the sound coming from the isokinetic dynamo-meter that will affect the measurements.
Flexibility Measurement:
It will be evaluated using the sit and reach test. Individuals will be asked to reach the as far as possible they can reach by extending their arms to the forward and stand still for 1-2 seconds at the last point without bending participants' knees. The distance will be recorded in 'cm' and the best value will be used in the analysis.
Balance Measurements:
Flamingo Balance Test:
Static balance will be measured by Flamingo Balance Test. The subjects stood on the beam which was 50 cm long, 5 cm height and 3 cm wide. While balancing on the dominant leg, the free leg was flexed at the knee and the foot of this leg held close to the buttocks. Then the instructor will be started the stopwatch and the subjects tried to stand in this position for one minute. The stopwatch will be stopped each time the subjects lost the balance during 60 second. The number of falls of the individual will be recorded. The test will be repeated 3 times and a rest interval of 60 seconds will be given between repetitions. The best result will be recorded.
Y-Balance Test:
Dynamic balance will be measured with Y-balance test. Individuals will be asked to place one foot on the starting point on the center and both hands on the waist. Individuals will be reach the farthest point possible in the anterior, posteriomedial and posteriolateral directions with the free limb. The farthest point of the free limb will be measured with the tape measure. There will be 3 trials in each direction. In addition, the lower extremity length measurement will be used for scoring. (Spina Iliaca Anterior Superior-Medial Malleoli). The mixed reach distance will be calculated based on best value [(max anterior + max posteriomedial + max posteriolateral) / (3 x Lower Limb Length)] x100.
Anaerobic Power Tests:
Vertical Jump Test:
Explosive force of lower extremities will be evaluated using the counter movement vertical jump test. The tape measure will be placed and fixed on the wall in the vertical direction. The individuals will be positioned on the side of the wall. In this position, the arm will be extended and the point at which the longest finger reaches will be recorded. The subject will be started with their hands on their hips, they will then instructed to sink (approximately 120 knee angle) as high as possible. The distance between the touched point and jumped points on the tape measure will be measured and recorded in 'cm'. The test will be repeated 3 times and a rest interval of 60 seconds will be given between repetitions. The best result will be recorded.
Horizontal Jump Test:
Explosive force of lower extremities will be evaluated using the counter movement horizontal jump test. The tape measure will be placed horizontally and fixed on the hard ground. The individuals will be positioned on the '0' point of the tape measure. In this position, the arm will be extended and the point at which the longest finger reaches will be recorded. The subject will be jump with their hands on their hips (approximately 120 knee angle) as forward as possible with the double leg. The distance between the '0' point and jumped points on the tape measure will be measured and recorded in 'cm'. The test will be repeated 3 times and a rest interval of 60 seconds will be given between repetitions. The best result will be recorded.
Muscle Strength:
The evaluation of quadriceps and hamstring muscle concentric strength will be evaluated with the isokinetic dynamometer. Before the measurements, the bike will be used for warming for 5 minutes without resistance. The test will be performed 5 times at 120 ̊/sec angular speeds. The peak torque values of the results will be recorded in 'N / m'.
- Conditions
- Flexibility
- Being tested
- Proprioceptive Neuromuscular Facilitation stretching exercise, Static stretching exercise
- Keywords
- Flexibility, Proprioception, Physical Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular Facilitation stretching exerciseProcedure or surgery
Proprioceptive Neuromuscular Facilitation stretching exercises (contract-relax-antagonist-contract method) will be performed 6 repetition and totally 30 seconds stretching for hamstring muscle group will be performed.It will be applied 3 days in a week for 8 week.
Static stretching exerciseProcedure or surgery
Static stretching exercises will be applied 2 repetition. Totally 30 seconds stretching for hamstring muscle group will be performed. It will be applied 3 days in a week for 8 week.
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation stretching exercises | Experimental | Proprioceptive Neuromuscular Facilitation stretching exercises (contract-relax-antagonist-contract method) will be performed 6 repetition and totally 30 seconds stretching for hamstring muscle group will be performed. Receives: Procedure: Proprioceptive Neuromuscular Facilitation stretching exercise |
| Static stretching exercises | Experimental | Passive Static Stretching exercises will be performed 2 repetition and totally 30 seconds stretching for hamstring muscle group will be performed. Receives: Procedure: Static stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between baseline of Knee Extension test and after 8th week
The knee extension test will be evaluated with goniometer.
Measured: The test will be performed 2 times. Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
Change between baseline of Position Sense test and after 8th week
The position sense will be evaluated with isokinetic dynamometer.
Measured: The test will be performed 2 times. Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
Change between baseline of Motion Sense and after 8th week
The motion sense will be evaluated with isokinetic dynamometer.
Measured: The test will be performed 2 times. Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
Secondary outcomes (24)
Change between baseline of Knee Extension Test and after first stretching exercise
The knee extension test will be evaluated with goniometer.
Measured: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change on Knee Extension Test after 6 week follow up period
The knee extension test will be evaluated with goniometer.
Measured: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Position Sense test and after first stretching exercise
The position sense will be evaluated with isokinetic dynamometer.
Measured: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change on Position Sense test after 6 week follow up period
The position sense will be evaluated with isokinetic dynamometer.
Measured: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Motion Sense test and after first stretching exercise
The motion sense will be evaluated with isokinetic dynamometer.
Measured: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change on Motion Sense after 6 week follow up period
The motion sense will be evaluated with isokinetic dynamometer.
Measured: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Flexibility and after first stretching exercise
Flexibility will be evaluated by the sit-reach test in cm.
Measured: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change between baseline of Flexibility and after 8th week
Flexibility will be evaluated by the sit-reach test in cm.
Measured: Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
Change on Flexibility after 6 week follow up period
Flexibility will be evaluated by the sit-reach test in cm.
Measured: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Static Balance and after first stretching exercise
Static balance will be evaluated by the Flamingo Balance Test.
Measured: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change between baseline of Static Balance and after 8th week stretching exercise
Static balance will be evaluated by the Flamingo Balance Test.
Measured: Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
Change on Static Balance after 6 week follow up period
Static balance will be evaluated by the Flamingo Balance Test.
Measured: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Dynamic Balance and after first stretching exercise
Static balance will be evaluated by the Y Balance Test.
Measured: Assessment will be performed baseline and after first stretching. Measurement takes about 10 minutes.
Change between baseline of Dynamic Balance and after 8th week stretching exercise
Static balance will be evaluated by the Y Balance Test.
Measured: Assessment will be performed baseline and after 8th weeks. Measurement takes about 10 minutes.
Change on Dynamic Balance after 6 week follow up period
Static balance will be evaluated by the Y Balance Test.
Measured: The test will be performed after 6 weeks follow up period. It takes about 10 minutes.
Change between baseline of Anaerobic Performance Tests-Vertical Jump Test and after first stretching exercise
Vertical jump performance will be evaluated by the Counter Movement Jump.
Measured: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change between baseline of Anaerobic Performance Tests-Vertical Jump Test and after 8th week stretching exercise
Vertical jump performance will be evaluated by the Counter Movement Jump.
Measured: Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
Change on Anaerobic Performance Tests-Vertical Jump Test and after 6 week follow up period
Vertical jump performance will be evaluated by the Counter Movement Jump.
Measured: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Anaerobic Performance Tests-Horizontal Jump Test and after first stretching exercise
Horizontal Jump Test will be used for horizontal evaluation of explosive force of lower extremities.
Measured: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change between baseline of Anaerobic Performance Tests-Horizontal Jump Test and after 8th week stretching exercise
Horizontal Jump Test will be used for horizontal evaluation of explosive force of lower extremities.
Measured: Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
Change on Anaerobic Performance Tests-Horizontal Jump Test after 6 week follow up period
Horizontal Jump Test will be used for horizontal evaluation of explosive force of lower extremities.
Measured: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Muscle Strength and after first stretching exercise
Muscle strength will be evaluated with isokinetic dynamometer in N /m.
Measured: Assessment will be performed baseline and after first stretching. Measurement takes about 15 minutes.
Change between baseline of Muscle Strength and after 8th week stretching exercise
Muscle strength will be evaluated with isokinetic dynamometer in N /m.
Measured: Assessment will be performed baseline and after 8th weeks. Measurement takes about 15 minutes.
Change on Muscle Strength after 6 week follow up period
Muscle strength will be evaluated with isokinetic dynamometer in N /m.
Measured: The test will be performed after 6 weeks follow up period. It takes about 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start22 Jul 2019
- Primary completion10 Jan 2022
- Study completion8 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for FlexibilityStudies 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ece Mani, MPT, Principal investigator, Eastern Mediterranean UniversityBerkiye Kırmızıgil, DPT, Study director, Eastern Mediterranean UniversityEmine H Tüzün, DPT, Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026646
- Sponsor's protocol ID
- 2019/09-13
- Status last verified
- Jan 2022
- First submitted
- 3 Jul 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bouet V, Gahery Y. Muscular exercise improves knee position sense in humans. Neurosci Lett. 2000 Aug 4;289(2):143-6. doi: 10.1016/s0304-3940(00)01297-0.
PubMed 10904140Hassan BS, Mockett S, Doherty M. Static postural sway, proprioception, and maximal voluntary quadriceps contraction in patients with knee osteoarthritis and normal control subjects. Ann Rheum Dis. 2001 Jun;60(6):612-8. doi: 10.1136/ard.60.6.612.
PubMed 11350851Roijezon U, Clark NC, Treleaven J. Proprioception in musculoskeletal rehabilitation. Part 1: Basic science and principles of assessment and clinical interventions. Man Ther. 2015 Jun;20(3):368-77. doi: 10.1016/j.math.2015.01.008. Epub 2015 Jan 29.
PubMed 25703454Ghaffarinejad F, Taghizadeh S, Mohammadi F. Effect of static stretching of muscles surrounding the knee on knee joint position sense. Br J Sports Med. 2007 Oct;41(10):684-7. doi: 10.1136/bjsm.2006.032425. Epub 2007 May 17.
PubMed 17510229Bjorklund M, Hamberg J, Crenshaw AG. Sensory adaptation after a 2-week stretching regimen of the rectus femoris muscle. Arch Phys Med Rehabil. 2001 Sep;82(9):1245-50. doi: 10.1053/apmr.2001.24224.
PubMed 11552198Larsen R, Lund H, Christensen R, Rogind H, Danneskiold-Samsoe B, Bliddal H. Effect of static stretching of quadriceps and hamstring muscles on knee joint position sense. Br J Sports Med. 2005 Jan;39(1):43-6. doi: 10.1136/bjsm.2003.011056.
PubMed 15618341Streepey JW, Mock MJ, Riskowski JL, Vanwye WR, Vitvitskiy BM, Mikesky AE. Effects of quadriceps and hamstrings proprioceptive neuromuscular facilitation stretching on knee movement sensation. J Strength Cond Res. 2010 Apr;24(4):1037-42. doi: 10.1519/JSC.0b013e3181d09e87.
PubMed 20300021Pincivero DM, Bachmeier B, Coelho AJ. The effects of joint angle and reliability on knee proprioception. Med Sci Sports Exerc. 2001 Oct;33(10):1708-12. doi: 10.1097/00005768-200110000-00015.
PubMed 11581556Mani E, Kirmizigil B, Tuzun EH. Effects of two different stretching techniques on proprioception and hamstring flexibility: a pilot study. J Comp Eff Res. 2021 Sep;10(13):987-999. doi: 10.2217/cer-2021-0040. Epub 2021 Jul 7.
PubMed 34231374
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Proprioceptive Neuromuscular Facilitation and Static Stretching Exercises on Proprioceptive Sensation and Performance
- ClinicalTrials.gov ID
- NCT04026646
- Acronym / sponsor ID
- 2019/09-13
- Conditions
- Flexibility
- Keywords
- Flexibility, Proprioception, Physical Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 8 Mar 2022 (estimated)
- First posted
- 19 Jul 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.
In this randomized trial, the aim of study is compare acute and chronic effect of Proprioceptive Neuromuscular Facilitation stretching and static stretching in individuals with shortness hamstring in proprioception and performance. The primary outcome measurement is proprioception (position sense and motion sense), the secondary outcome measurements are physical performance evaluations.
All exercises will be performed by the same physiotherapist in 8 weeks and 3 times a week. Exercises will be performed bilaterally and data from the dominant lower extremity will be used in the analysis. Exercises and assessments to reduce the effects of circadian variation will be performed at the same times during the research.
Detailed description
Joint proprioception can be defined as the body's ability to determine position and detection movement without vision perception. Proprioception is provided from the stimulation of specialized nerve endings and mechanoreceptors located in and around the joints, such as muscles, tendons, fascia, joint capsule, and ligaments. The muscle spindle and golgi tendon organ are the most important receptors involved in the proprioceptive sensation of the knee joint.
In the literature, there are studies have investigated the effect of static stretching exercises on the sense of position. Some of these studies showed an improvement on position sense, while one study showed no effect. There are a limited number of studies have investigated the effects of Proprioceptive Neuromuscular Facilitation (PNF) stretching techniques on proprioceptive senses. However, the effects of static stretching and PNF stretching on kinesthesia have not been studied.
The aim of this study is to compare acute and chronic effect of PNF stretching and static stretching in individuals with shortness hamstring in proprioception and performance.
Hypothesis of research
H01: The acute effects of static stretching and PNF stretching exercises on the results of proprioceptive sensation are similar.
H02: The chronic effects of static stretching and PNF stretching exercises on the results of proprioceptive sensation are similar.
H03: The acute effects of static stretching and PNF stretching exercises on the results of physical performance are similar.
H04: The chronic effects of static stretching and PNF stretching exercises on the results of physical performance are similar.
The Universe and Sample of the Research:
A sample size calculation was performed using the G* Power software (version 3.1.9.2), taking into account the statistical tests to be used in the analyses, and the conventional effect size values proposed by Cohen. It was estimated that 27 subjects would be needed in each group (α=0.05, β=0.20, and Cohen d=0.8) in order to detect statistically significant difference in a Mann Whitney U test. Considering the samples that could not complete the study, this first sample size was increased by 10% and the final sample size was calculated as 30 in each group.
Methods:
The study will include volunteer sedentary male subjects aged between 20-29 years. The study will be carried out in the athlete's lab of the Eastern Mediterranean University.
Participants in the study who have signed a voluntary consent form will be informed about the study. Then, the evaluation starts with the socio-demographic data of the participants (age, gender, height, weight, dominant side). Evaluations will be performed as knee extension angle, proprioceptive sense, flexibility assessment, balance, explosive power tests and muscle strength assessment. Individuals will be divided into two groups by minimization randomization method. 30 seconds contract-relax-antagonist-contract method (CRAC) of Proprioceptive Neuromuscular Facilitation stretching exercises for hamstring muscle will be performed to Group 1 and 30 seconds static stretching exercises for hamstring muscle will be performed to Group 2.
To assess the acute effect, exercise will be performed after the first assessment and then all assessments will be repeated. To investigate the chronic effect, all exercises will be performed in 8 weeks and 3 times a week. After 6 weeks follow-up period, all participants will be evaluated again.
Evaluations in the Research
Knee Extension Test:
The individual's hip will be stabilized at 90 degrees flexion with 1 hand supporting the subject's distal thigh and the other hand cupping the heel. Physiotherapist passively extended the knee until the individual feels mild tension in hamstring muscle. At this point, it will measured the angle using a goniometer. Full knee extension would be equivalent to an angle of 180°. The angle missing from the full knee extension will be recorded as 'degree'.
Proprioceptive Sensory Measurements:
Isokinetic dynamometer will be used to evaluate the knee joint proprioceptive sense of subjects. The subjects will placed in a 90° hip flexion sitting position. Subjects will be informed about the tests. Before the test, a trial will be performed. Between the three tests 30 seconds rest period will be given. The difference between the target angle and the measured angle will be registered as absolute error. Averages of three measurements will be analyzed.
For motion sense measurements, 10° knee flexion position was selected for kinesthesia measurements. The subjects will be instructed to press the dynamometer lock button as soon as they will perceive any movement in the knee joint. 45° knee flexion position will be used in the measurement of position sense. The knee will be started in the 90° flexion position and before the test, target knee position will be taught during 5 seconds. Afterwards, the knee will be placed to starting position. Subjects will be asked to push the warning button as soon as they feel they will reach the target angle.
Room temperature will be kept at 25°C during the tests. Air splints will be used to eliminate the tactile sense. While care will be taken to preserve the silence of the environment, subjects will be dressed in headphones at the same time to prevent the sound coming from the isokinetic dynamo-meter that will affect the measurements.
Flexibility Measurement:
It will be evaluated using the sit and reach test. Individuals will be asked to reach the as far as possible they can reach by extending their arms to the forward and stand still for 1-2 seconds at the last point without bending participants' knees. The distance will be recorded in 'cm' and the best value will be used in the analysis.
Balance Measurements:
Flamingo Balance Test:
Static balance will be measured by Flamingo Balance Test. The subjects stood on the beam which was 50 cm long, 5 cm height and 3 cm wide. While balancing on the dominant leg, the free leg was flexed at the knee and the foot of this leg held close to the buttocks. Then the instructor will be started the stopwatch and the subjects tried to stand in this position for one minute. The stopwatch will be stopped each time the subjects lost the balance during 60 second. The number of falls of the individual will be recorded. The test will be repeated 3 times and a rest interval of 60 seconds will be given between repetitions. The best result will be recorded.
Y-Balance Test:
Dynamic balance will be measured with Y-balance test. Individuals will be asked to place one foot on the starting point on the center and both hands on the waist. Individuals will be reach the farthest point possible in the anterior, posteriomedial and posteriolateral directions with the free limb. The farthest point of the free limb will be measured with the tape measure. There will be 3 trials in each direction. In addition, the lower extremity length measurement will be used for scoring. (Spina Iliaca Anterior Superior-Medial Malleoli). The mixed reach distance will be calculated based on best value [(max anterior + max posteriomedial + max posteriolateral) / (3 x Lower Limb Length)] x100.
Anaerobic Power Tests:
Vertical Jump Test:
Explosive force of lower extremities will be evaluated using the counter movement vertical jump test. The tape measure will be placed and fixed on the wall in the vertical direction. The individuals will be positioned on the side of the wall. In this position, the arm will be extended and the point at which the longest finger reaches will be recorded. The subject will be started with their hands on their hips, they will then instructed to sink (approximately 120 knee angle) as high as possible. The distance between the touched point and jumped points on the tape measure will be measured and recorded in 'cm'. The test will be repeated 3 times and a rest interval of 60 seconds will be given between repetitions. The best result will be recorded.
Horizontal Jump Test:
Explosive force of lower extremities will be evaluated using the counter movement horizontal jump test. The tape measure will be placed horizontally and fixed on the hard ground. The individuals will be positioned on the '0' point of the tape measure. In this position, the arm will be extended and the point at which the longest finger reaches will be recorded. The subject will be jump with their hands on their hips (approximately 120 knee angle) as forward as possible with the double leg. The distance between the '0' point and jumped points on the tape measure will be measured and recorded in 'cm'. The test will be repeated 3 times and a rest interval of 60 seconds will be given between repetitions. The best result will be recorded.
Muscle Strength:
The evaluation of quadriceps and hamstring muscle concentric strength will be evaluated with the isokinetic dynamometer. Before the measurements, the bike will be used for warming for 5 minutes without resistance. The test will be performed 5 times at 120 ̊/sec angular speeds. The peak torque values of the results will be recorded in 'N / m'.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation stretching exercises | Experimental | Procedure: Proprioceptive Neuromuscular Facilitation stretching exerciseProprioceptive Neuromuscular Facilitation stretching exercises (contract-relax-antagonist-contract method) will be performed 6 repetition and totally 30 seconds stretching for hamstring muscle group will be performed. |
| Static stretching exercises | Experimental | Procedure: Static stretching exercisePassive Static Stretching exercises will be performed 2 repetition and totally 30 seconds stretching for hamstring muscle group will be performed. |
Who may qualify
- Ages
- 20 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being between 20-29 years of age,
- Male individuals,
- Individuals who have not participated in physical activity for the last 6 months,
- Who have the knee extension angle more than 20⁰,
- Who accept the conditions of the study and sign the written informed consent form.
Key exclusion criteria (3 listed)
- Patients who have lower extremity injuries in the last 6 months,
- Who have visual or vestibular impairments except of refractive problems,
- Who have traumatic problems, who have rheumatologic, orthopedic or neuromuscular disease, Black people (due to muscle structure).
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 |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation stretching exerciseProprioceptive Neuromuscular Facilitation stretching exercises (contract-relax-antagonist-contract method) will be performed 6 repetition and totally 30 seconds stretching for hamstring muscle group will be performed.It will be applied 3 days in a week for 8 week. | Procedure or surgery | Proprioceptive Neuromuscular Facilitation stretching exercises |
| Static stretching exerciseStatic stretching exercises will be applied 2 repetition. Totally 30 seconds stretching for hamstring muscle group will be performed. It will be applied 3 days in a week for 8 week. | Procedure or surgery | Static stretching exercises |
Primary outcome
Change between baseline of Knee Extension test and after 8th week
Time frame: The test will be performed 2 times. Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
The knee extension test will be evaluated with goniometer.
Change between baseline of Position Sense test and after 8th week
Time frame: The test will be performed 2 times. Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
The position sense will be evaluated with isokinetic dynamometer.
Change between baseline of Motion Sense and after 8th week
Time frame: The test will be performed 2 times. Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
The motion sense will be evaluated with isokinetic dynamometer.
24 secondary outcomes
Change between baseline of Knee Extension Test and after first stretching exercise
Time frame: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change on Knee Extension Test after 6 week follow up period
Time frame: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Position Sense test and after first stretching exercise
Time frame: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change on Position Sense test after 6 week follow up period
Time frame: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Motion Sense test and after first stretching exercise
Time frame: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change on Motion Sense after 6 week follow up period
Time frame: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Flexibility and after first stretching exercise
Time frame: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change between baseline of Flexibility and after 8th week
Time frame: Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
Change on Flexibility after 6 week follow up period
Time frame: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Static Balance and after first stretching exercise
Time frame: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change between baseline of Static Balance and after 8th week stretching exercise
Time frame: Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
Change on Static Balance after 6 week follow up period
Time frame: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Dynamic Balance and after first stretching exercise
Time frame: Assessment will be performed baseline and after first stretching. Measurement takes about 10 minutes.
Change between baseline of Dynamic Balance and after 8th week stretching exercise
Time frame: Assessment will be performed baseline and after 8th weeks. Measurement takes about 10 minutes.
Change on Dynamic Balance after 6 week follow up period
Time frame: The test will be performed after 6 weeks follow up period. It takes about 10 minutes.
Change between baseline of Anaerobic Performance Tests-Vertical Jump Test and after first stretching exercise
Time frame: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change between baseline of Anaerobic Performance Tests-Vertical Jump Test and after 8th week stretching exercise
Time frame: Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
Change on Anaerobic Performance Tests-Vertical Jump Test and after 6 week follow up period
Time frame: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Anaerobic Performance Tests-Horizontal Jump Test and after first stretching exercise
Time frame: Assessment will be performed baseline and after first stretching. Measurement takes about 5 minutes.
Change between baseline of Anaerobic Performance Tests-Horizontal Jump Test and after 8th week stretching exercise
Time frame: Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.
Change on Anaerobic Performance Tests-Horizontal Jump Test after 6 week follow up period
Time frame: The test will be performed after 6 weeks follow up period. It takes about 5 minutes.
Change between baseline of Muscle Strength and after first stretching exercise
Time frame: Assessment will be performed baseline and after first stretching. Measurement takes about 15 minutes.
Change between baseline of Muscle Strength and after 8th week stretching exercise
Time frame: Assessment will be performed baseline and after 8th weeks. Measurement takes about 15 minutes.
Change on Muscle Strength after 6 week follow up period
Time frame: The test will be performed after 6 weeks follow up period. It takes about 15 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Background: PubMed 10904140Bouet V, Gahery Y. Muscular exercise improves knee position sense in humans. Neurosci Lett. 2000 Aug 4;289(2):143-6. doi: 10.1016/s0304-3940(00)01297-0.
- Background: PubMed 11350851Hassan BS, Mockett S, Doherty M. Static postural sway, proprioception, and maximal voluntary quadriceps contraction in patients with knee osteoarthritis and normal control subjects. Ann Rheum Dis. 2001 Jun;60(6):612-8. doi: 10.1136/ard.60.6.612.
- Background: PubMed 25703454Roijezon U, Clark NC, Treleaven J. Proprioception in musculoskeletal rehabilitation. Part 1: Basic science and principles of assessment and clinical interventions. Man Ther. 2015 Jun;20(3):368-77. doi: 10.1016/j.math.2015.01.008. Epub 2015 Jan 29.
- Background: PubMed 17510229Ghaffarinejad F, Taghizadeh S, Mohammadi F. Effect of static stretching of muscles surrounding the knee on knee joint position sense. Br J Sports Med. 2007 Oct;41(10):684-7. doi: 10.1136/bjsm.2006.032425. Epub 2007 May 17.
- Background: PubMed 11552198Bjorklund M, Hamberg J, Crenshaw AG. Sensory adaptation after a 2-week stretching regimen of the rectus femoris muscle. Arch Phys Med Rehabil. 2001 Sep;82(9):1245-50. doi: 10.1053/apmr.2001.24224.
- Background: PubMed 15618341Larsen R, Lund H, Christensen R, Rogind H, Danneskiold-Samsoe B, Bliddal H. Effect of static stretching of quadriceps and hamstring muscles on knee joint position sense. Br J Sports Med. 2005 Jan;39(1):43-6. doi: 10.1136/bjsm.2003.011056.
- Background: PubMed 20300021Streepey JW, Mock MJ, Riskowski JL, Vanwye WR, Vitvitskiy BM, Mikesky AE. Effects of quadriceps and hamstrings proprioceptive neuromuscular facilitation stretching on knee movement sensation. J Strength Cond Res. 2010 Apr;24(4):1037-42. doi: 10.1519/JSC.0b013e3181d09e87.
- Background: PubMed 11581556Pincivero DM, Bachmeier B, Coelho AJ. The effects of joint angle and reliability on knee proprioception. Med Sci Sports Exerc. 2001 Oct;33(10):1708-12. doi: 10.1097/00005768-200110000-00015.
- Derived from this study: PubMed 34231374Mani E, Kirmizigil B, Tuzun EH. Effects of two different stretching techniques on proprioception and hamstring flexibility: a pilot study. J Comp Eff Res. 2021 Sep;10(13):987-999. doi: 10.2217/cer-2021-0040. Epub 2021 Jul 7.
- The Measurement Of Knee Joint Position SenseLink provided by the sponsor.
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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.
Ece Mani, MPT principal investigator
Eastern Mediterranean University
Berkiye Kırmızıgil, DPT study director
Eastern Mediterranean University
Emine H Tüzün, DPT study director
Eastern Mediterranean 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 Proprioceptive Neuromuscular Facilitation stretching exercise and Static stretching exercise in people with Flexibility, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).
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 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: status not confirmed, as of the sponsor's last update on 11 Jan 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ece Mani, MPT (+905488219691, ece.mani13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between baseline of Knee Extension test and after 8th week (time frame: The test will be performed 2 times. Assessment will be performed baseline and after 8th weeks. Measurement takes about 5 minutes.). The study lists 3 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 NCT04026646, which also lists 9 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 11 Jan 2022.