Muscle StrainNCT03966690
Rate of Leg Curl to Leg Press During Isokinetic Testing
A study testing Isokinetic leg extension/-flexion on a legpress device and Isokinetic leg extension/-flexion on a legcurl device in people with Muscle Strain, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The functional condition of the leg muscles is not only relevant to performance in sports, but is also of great importance in health, prevention and rehabilitation, where not only the general strength level is decisive but also the relationship between individual muscle groups. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men only
- Conditions the study is for
- Muscle Strain
- What is being tested?
- Isokinetic leg extension/-flexion on a legpress device and Isokinetic leg extension/-flexion on a legcurl device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- 15 Aug 2018to 15 May 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 35 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- male elite soccer players (5th-6th German soccer division)
Who cannot join
- no acute injuries
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Medical Physics, University of Erlangen-Nurnberg
Erlangen, 91052
About this study
Official title: Maximum Strength and Ratio of Leg Extension and Leg Flexion in Elite Soccer Players. A Comparison of an Open Versus Closed Isokinetic System
The functional condition of the leg muscles is not only relevant to performance in sports, but is also of great importance in health, prevention and rehabilitation, where not only the general strength level is decisive but also the relationship between individual muscle groups. Among other things the H-Q-ratio (strength ratio of "hamstring" muscles to quadriceps muscles) is often used to diagnose possible imbalances. Isokinetic force measurements have established themselves as the gold standard in competitive football. In this context, however, force tests in the open kinetic chain (OKC) have almost exclusively been used so far. Especially force measurements in the closed kinetic chain (CKC) could have a higher relevance regarding functionality. The H-Q-ratio should better be called the flex-ext-ratio in the CKC due to the involvement of the hip muscles. There is little data in the literature on leg force or flex-ext-ratio in CKC. In particular, there is hardly any comparative data for isokinetic measurement systems in the CKC. Using a cross over design and randomly allocating 28 competitive football players into two groups (n=14 each) that either started tests with the leg press or legcurl device, the investigators assumed (1) a significantly lower flex-ext-ratio in the CKC compared to the OKC, (2) a correlation between the isokinetic measurement systems in the OKC and the CKC, and (3) a significant superiority of the leg press to predict functional performance of the lower limbs.
- Conditions
- Muscle Strain
- Being tested
- Isokinetic leg extension/-flexion on a legpress device, Isokinetic leg extension/-flexion on a legcurl device
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic leg extension/-flexion on a legpress deviceDevice
Maximum strength and rate of leg-flexion /-extension during legpress exercise
Isokinetic leg extension/-flexion on a legcurl deviceDevice
Maximum strength and rate of leg-flexion /-extension during legcurl exercise
| Study group | Role | What they receive |
|---|---|---|
| leg curl device starters | Experimental | Group A randomly assigned to start with legcurl device Receives: Device: Isokinetic leg extension/-flexion on a legpress device; Device: Isokinetic leg extension/-flexion on a legcurl device |
| legpress device starters | Experimental | Group A randomly assigned to start with legpress device Receives: Device: Isokinetic leg extension/-flexion on a legpress device; Device: Isokinetic leg extension/-flexion on a legcurl device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg extension/leg-flexion rate
Rate of leg extension to leg-flexion
Measured: at baseline
Secondary outcomes (4)
Isokinetic leg extensors strength
Maximum isokinetic strength of the leg extensors as determined by an isokinetic legpress device (Physiomed, Laipersdorf, Germany)
Measured: at baseline
Isokinetic leg flexors strength
Maximum isokinetic strength of the leg flexors as determined by an isokinetic legpress device (Physiomed, Laipersdorf, Germany)
Measured: at baseline
Y-Balance Test
Dynamic motor-control as determined by the Y-Balance test
Measured: at baseline
Maximum jumping height
Maximum jumping height as determined by the counter movement jump
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start15 Aug 2018
- Primary completion15 Feb 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StrainStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolfgang Kemmler, PhD, Study chair, Institute of Medical Physics, University of Erlangen-Nürnberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966690
- Sponsor's protocol ID
- IMP_Test
- Status last verified
- May 2019
- First submitted
- 23 May 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximum Strength and Ratio of Leg Extension and Leg Flexion in Elite Soccer Players. A Comparison of an Open Versus Closed Isokinetic System
- ClinicalTrials.gov ID
- NCT03966690
- Acronym / sponsor ID
- IMP_Test
- Conditions
- Muscle Strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 29 May 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.
The functional condition of the leg muscles is not only relevant to performance in sports, but is also of great importance in health, prevention and rehabilitation, where not only the general strength level is decisive but also the relationship between individual muscle groups. Among other things the H-Q-ratio (strength ratio of "hamstring" muscles to quadriceps muscles) is often used to diagnose possible imbalances. Isokinetic force measurements have established themselves as the gold standard in competitive football. In this context, however, force tests in the open kinetic chain (OKC) have almost exclusively been used so far. Especially force measurements in the closed kinetic chain (CKC) could have a higher relevance regarding functionality. The H-Q-ratio should better be called the flex-ext-ratio in the CKC due to the involvement of the hip muscles. There is little data in the literature on leg force or flex-ext-ratio in CKC. In particular, there is hardly any comparative data for isokinetic measurement systems in the CKC. Using a cross over design and randomly allocating 28 competitive football players into two groups (n=14 each) that either started tests with the leg press or legcurl device, the investigators assumed (1) a significantly lower flex-ext-ratio in the CKC compared to the OKC, (2) a correlation between the isokinetic measurement systems in the OKC and the CKC, and (3) a significant superiority of the leg press to predict functional performance of the lower limbs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| leg curl device starters | Experimental | Device: Isokinetic leg extension/-flexion on a legpress device, Device: Isokinetic leg extension/-flexion on a legcurl deviceGroup A randomly assigned to start with legcurl device |
| legpress device starters | Experimental | Device: Isokinetic leg extension/-flexion on a legpress device, Device: Isokinetic leg extension/-flexion on a legcurl deviceGroup A randomly assigned to start with legpress device |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- male elite soccer players (5th-6th German soccer division)
Key exclusion criteria (1 listed)
- no acute injuries
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 |
|---|---|---|
| Isokinetic leg extension/-flexion on a legpress deviceMaximum strength and rate of leg-flexion /-extension during legpress exercise | Device | leg curl device starters, legpress device starters |
| Isokinetic leg extension/-flexion on a legcurl deviceMaximum strength and rate of leg-flexion /-extension during legcurl exercise | Device | leg curl device starters, legpress device starters |
Primary outcome
Leg extension/leg-flexion rate
Time frame: at baseline
Rate of leg extension to leg-flexion
4 secondary outcomes
Isokinetic leg extensors strength
Time frame: at baseline
Isokinetic leg flexors strength
Time frame: at baseline
Y-Balance Test
Time frame: at baseline
Maximum jumping height
Time frame: at baseline
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 31 May 2019.
- Individual participant dataSharing planned: No
Related trials for Muscle Strain
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Strain Counter Strain and Muscle Energy Technique in Non-specific Low Back Pain
Low Back Pian
Recruiting
Passive Calf Stretching Therapy in Peripheral Artery Disease
Peripheral Artery Disease, Claudication, Intermittent
Recruiting
Effects Of Criteria Versus Time-Based Rehabilitation On Return To Play In Football Players
Hamstring Muscle Strain
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.
Wolfgang Kemmler, PhD study chair
Institute of Medical Physics, University of Erlangen-Nürnberg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isokinetic leg extension/-flexion on a legpress device and Isokinetic leg extension/-flexion on a legcurl device in people with Muscle Strain, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 1 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 31 May 2019. 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 Germany. 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?
Leg extension/leg-flexion rate (time frame: at baseline). 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 31 May 2019.