Lower Limb InjuryNCT05167162
Efficacy of the Most Commonly Used Physiotherapeutic Treatments for Acute Lower Limb Fatigue in Athletes
A study testing State-Trait Anxiety Questionnaire, Rating of Perceived Exertion and Motor coordination tests in people with Lower Limb Injury, run by Clinica Gema Leon at 1 site in Spain.
Trial summary
Acute fatigue is the inability to generate a required or expected level of force or exercise intensity, whether or not preceded by previous exercise. It is an important risk factor in overuse injuries. It is multifactorial in nature and its mechanisms of formation are imprecise. Read more about this study
- Who is it for?
- Ages 20 to 25 years
- Conditions the study is for
- Lower Limb Injury
- What is being tested?
- State-Trait Anxiety Questionnaire, Rating of Perceived Exertion and Motor coordination tests
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 6 Nov 2021to 30 Apr 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Active athletes
- Presentation of typical clinical signs of acute fatigue in one of the two lower limbs
- Positive diagnosis of acute fatigue
Who cannot join
- Not compatible with age range
- Healthy athletes
- Diagnosed injuries other than acute fatigue
Trial locations and contacts
1 site in 1 country.
Spain1 site
Gema León Physiotherapy and Rehabilitation Clinic
Córdoba, Andalusia, 14011
About this study
Acute fatigue is the inability to generate a required or expected level of force or exercise intensity, whether or not preceded by previous exercise. It is an important risk factor in overuse injuries. It is multifactorial in nature and its mechanisms of formation are imprecise. This type of fatigue can affect both the peripheral level, generating neuromuscular or peripheral fatigue, and the central level, generating central fatigue Objective: To study several physiotherapeutic protocols, analyzing the degree of effectiveness of each one for the recovery of acute fatigue in athletes. Design: Prospective randomized experimental study with 4 groups of physiotherapeutic protocols suitable in acute fatigue recovery. Participants: Presentation of 80 patients treated with 4 therapeutic protocols, equally divided and purposely sexed. The four protocols were divided into: Active recovery (n=20) hydrotherapy (n=20) massage (n=20) and compression (n=20) for 4 weeks of treatment. Intervention: Active recovery protocols (group 1) hydrotherapy protocol (group 2) massage protocol (group 3) and comprehension protocol (group 4).
Keywords: Lower limbs, physiotherapy, athlete, biomechanics, protocol.
Read the detailed description
The etiology of injury in sport is multifactorial, generated by both intrinsic and extrinsic factors. There is evidence that supports that the management and handling of loads is the factor that generates the greatest risk of injury and that not respecting the load-recovery balance can lead to an accumulation of fatigue resulting in poor training adaptation which leads to increased risk of injury. From a physiological approach, fatigue is defined as a functional failure of the organism which, due to excessive energy expenditure and depletion of substrates necessary for energy production, leads to a decrease in performance.
Acute fatigue is the inability to generate a required or expected level of exercise force or intensity, whether or not preceded by previous exercise. Acute fatigue is an important risk factor in overuse injuries. It is multifactorial in nature and its mechanisms of formation are imprecise. This type of fatigue can affect both the peripheral level, generating neuromuscular or peripheral fatigue, and the central level, generating central fatigue. Peripheral or neuromuscular fatigue is the result of altered musculoskeletal homeostasis due to a limitation or failure of one or more motor unit processes, producing a dysfunction in the contraction process. Central fatigue is an involuntary failure in brain function or nerve impulse conduction, resulting in impaired transmission from the central nervous system (CNS) and impaired motor axon recruitment. One of the main factors associated with central fatigue is the alteration of synthesis and activity of some neurotransmitters.
Elite athletes push their training to the limit in order to maximize their performance. This generates muscle damage that results in a breakdown of structural proteins of muscle fibers and connective tissues, causing tissue inflammation, Delayed Onset Muscle Soreness (DOMS) and an increase in perceived fatigue. To maximize an athlete's ability to perform, it is not only the training that must be addressed, but also the balance between training and recovery. This prevents maladaptation to physiological and psychological stresses induced by the load. Therefore, it is important for the athlete to optimize the recovery period to reduce the risk of injury.
The purpose of this research is to demonstrate the efficacy of various physiotherapeutic protocols, analyzing the degree of effectiveness in each of these for recovery from acute fatigue in athletes.
- Conditions
- Lower Limb Injury
- Being tested
- State-Trait Anxiety Questionnaire, Rating of Perceived Exertion, Motor coordination tests, Physiotherapeutic intervention, Data Analysis
- Keywords
- Lower limbs, Physiotherapy, Athlete, Biomechanics, Protocol
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
State-Trait Anxiety QuestionnaireDiagnostic test
Also called STAI
The scale measures ordinally (1 to 5) the values observed during exposure to anxiety patterns during exercise, such as higher repetitions, greater weight gain or longer exercise duration, as follows:
- Not at all
- Little
- Sometimes
- Almost always
- Always
Rating of Perceived ExertionDiagnostic test
Also called RPE
The scale measures in ordinal form (1 to 6) the perceived effort during the exercise as follows:
- No pain
- Little pain
- Moderate
- Severe
- Very strong
- Unbearable
Motor coordination testsDiagnostic test
The motor coordination tests are divided into three:
- Jumping with 2 feet together.
- Throwing 2 balls from a given distance and space.
- Proprioception turns
Physiotherapeutic interventionProcedure or surgery
Participants received one session per week, until a total of 20 sessions were completed: Group 1 (n=20) received the muscle compression treatment. Group 2 (n=20) received the manual massage treatment. Group 3 (n=20) received the hydrotherapy treatment and group 4 (n=20) received the active recovery treatment.
Data AnalysisOther
The usual descriptive parameters (mean and standard deviation) of the sample were calculated. The distribution and analysis of the other data were performed by means of a nonparametric test (Mann-Whitney U test) comparing the groups. A confidence level of 95% was established, considering a value of p<0.05 as statistically significant.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Compression technique | Active comparator | 20 participants make up the compression technique group. Receives: Diagnostic Test: State-Trait Anxiety Questionnaire; Diagnostic Test: Rating of Perceived Exertion; Diagnostic Test: Motor coordination tests; Procedure: Physiotherapeutic intervention; Other: Data Analysis |
| Group 2: Massage techniques | Active comparator | 20 participants make up the massage technique group. Receives: Diagnostic Test: State-Trait Anxiety Questionnaire; Diagnostic Test: Rating of Perceived Exertion; Diagnostic Test: Motor coordination tests; Procedure: Physiotherapeutic intervention; Other: Data Analysis |
| Group 3: Hydromassage | Active comparator | 20 participants make up the hydromassage technique group. Receives: Diagnostic Test: State-Trait Anxiety Questionnaire; Diagnostic Test: Rating of Perceived Exertion; Diagnostic Test: Motor coordination tests; Procedure: Physiotherapeutic intervention; Other: Data Analysis |
| Group 4: Active recovery technique. | Active comparator | 20 participants make up the active recovery technique group. Receives: Diagnostic Test: State-Trait Anxiety Questionnaire; Diagnostic Test: Rating of Perceived Exertion; Diagnostic Test: Motor coordination tests; Procedure: Physiotherapeutic intervention; Other: Data Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Questionnaire (STAI)
The range or index of anxiety perceived during the exam and the ability to tolerate anxious moments are evaluated.
Measured: five months
Rating of Perceived Exertion (RPE)
The range or rate of perceived exertion during the scan is evaluated.
Measured: five months
Scale Countermovement jump (CMJ)
The range or index of neuromuscular performance during the scan is evaluated.
Measured: five months
Secondary outcomes (1)
Number of participants in each physical therapy application
Five reviews were carried out corresponding to the five months of treatment. During these five months, the participants received one session per week, until a total of 20 sessions were completed:
- Group 1 (n=20) received the muscle compression treatment.
- Group 2 (n=20) received the manual massage treatment.
- Group 3 (n=20) received the hydrotherapy treatment.
- Group 4 (n=20) received the active recovery treatment.
Measured: five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start6 Nov 2021
- Primary completion21 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Lower Limb InjuryStudies 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
- Crossover
- Model description
- 80 patients divided into 4 groups of equal size and randomly selected. The 4 treatment methods used will be as follows: Group 1: Compression techniques (n=20). Group 2: Massage techniques (n=20) Group 3: Hydrotherapy (n=20) Group 4: Active recovery technique (n=20)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Gema Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMA LEÓN BRAVO, Clinica Gema Leon
- Investigators
- Gema León Bravo, Physiotherap, Principal investigator, Gema León Physiotherapy and Rehabilitation ClinicRafael Arenas Quiles, Physiotherap, Study chair, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167162
- Sponsor's protocol ID
- ART-GLB-ACUTE FATIGUE
- Status last verified
- Aug 2024
- First submitted
- 6 Nov 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The request for the data will be studied and considered upon prior and justified request.
Publications
Benjaminse A, Webster KE, Kimp A, Meijer M, Gokeler A. Revised Approach to the Role of Fatigue in Anterior Cruciate Ligament Injury Prevention: A Systematic Review with Meta-Analyses. Sports Med. 2019 Apr;49(4):565-586. doi: 10.1007/s40279-019-01052-6.
PubMed 30659497Guan Y, Bredin S, Jiang Q, Taunton J, Li Y, Wu N, Wu L, Warburton D. The effect of fatigue on asymmetry between lower limbs in functional performances in elite child taekwondo athletes. J Orthop Surg Res. 2021 Jan 9;16(1):33. doi: 10.1186/s13018-020-02175-7.
PubMed 33422109Burton I. Autoregulation in Resistance Training for Lower Limb Tendinopathy: A Potential Method for Addressing Individual Factors, Intervention Issues, and Inadequate Outcomes. Front Physiol. 2021 Aug 5;12:704306. doi: 10.3389/fphys.2021.704306. eCollection 2021.
PubMed 34421641Trojian T, Driban J, Nuti R, Distefano L, Root H, Nistler C, LaBella C. Osteoarthritis action alliance consensus opinion - best practice features of anterior cruciate ligament and lower limb injury prevention programs. World J Orthop. 2017 Sep 18;8(9):726-734. doi: 10.5312/wjo.v8.i9.726. eCollection 2017 Sep 18.
PubMed 28979857Franke TPC, Backx FJG, Huisstede BMA. Lower extremity compression garments use by athletes: why, how often, and perceived benefit. BMC Sports Sci Med Rehabil. 2021 Mar 24;13(1):31. doi: 10.1186/s13102-020-00230-8.
PubMed 33761989Ghram A, Young JD, Soori R, Behm DG. Unilateral Knee and Ankle Joint Fatigue Induce Similar Impairment to Bipedal Balance in Judo Athletes. J Hum Kinet. 2019 Mar 27;66:7-18. doi: 10.2478/hukin-2018-0063. eCollection 2019 Mar.
PubMed 30988836Cejudo A, Sainz de Baranda P, Ayala F, De Ste Croix M, Santonja-Medina F. Assessment of the Range of Movement of the Lower Limb in Sport: Advantages of the ROM-SPORT I Battery. Int J Environ Res Public Health. 2020 Oct 19;17(20):7606. doi: 10.3390/ijerph17207606.
PubMed 33086605DeLang MD, Salamh PA, Farooq A, Tabben M, Whiteley R, van Dyk N, Chamari K. The dominant leg is more likely to get injured in soccer players: systematic review and meta-analysis. Biol Sport. 2021 Sep;38(3):397-435. doi: 10.5114/biolsport.2021.100265. Epub 2020 Oct 28.
PubMed 34475623Gilbert FC, Burdette GT, Joyner AB, Llewellyn TA, Buckley TA. Association Between Concussion and Lower Extremity Injuries in Collegiate Athletes. Sports Health. 2016 Nov/Dec;8(6):561-567. doi: 10.1177/1941738116666509. Epub 2016 Sep 20.
PubMed 27587598Drury B, Ratel S, Clark CCT, Fernandes JFT, Moran J, Behm DG. Eccentric Resistance Training in Youth: Perspectives for Long-Term Athletic Development. J Funct Morphol Kinesiol. 2019 Nov 28;4(4):70. doi: 10.3390/jfmk4040070.
PubMed 33467385Mang CS, Whitten TA, Cosh MS, Dukelow SP, Benson BW. Assessment of Postural Stability During an Upper Extremity Rapid, Bimanual Motor Task After Sport-Related Concussion. J Athl Train. 2020 Nov 1;55(11):1160-1173. doi: 10.4085/1062-6050-378-19.
PubMed 33064821Avedesian JM, Covassin T, Dufek JS. The Influence of Sport-Related Concussion on Lower Extremity Injury Risk: A Review of Current Return-to-Play Practices and Clinical Implications. Int J Exerc Sci. 2020 Aug 1;13(3):873-889. doi: 10.70252/WVYL1782. eCollection 2020.
PubMed 32922630Frutuoso AS, Diefenthaeler F, Vaz MA, Freitas Cde L. LOWER LIMB ASYMMETRIES IN RHYTHMIC GYMNASTICS ATHLETES. Int J Sports Phys Ther. 2016 Feb;11(1):34-43.
PubMed 26900498Siupsinskas L, Garbenyte-Apolinskiene T, Salatkaite S, Gudas R, Trumpickas V. Association of pre-season musculoskeletal screening and functional testing with sports injuries in elite female basketball players. Sci Rep. 2019 Jun 26;9(1):9286. doi: 10.1038/s41598-019-45773-0.
PubMed 31243317Dubose DF, Herman DC, Jones DL, Tillman SM, Clugston JR, Pass A, Hernandez JA, Vasilopoulos T, Horodyski M, Chmielewski TL. Lower Extremity Stiffness Changes after Concussion in Collegiate Football Players. Med Sci Sports Exerc. 2017 Jan;49(1):167-172. doi: 10.1249/MSS.0000000000001067.
PubMed 27501359
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Most Commonly Used Physiotherapeutic Treatments for Acute Lower Limb Fatigue in Athletes
- ClinicalTrials.gov ID
- NCT05167162
- Acronym / sponsor ID
- ART-GLB-ACUTE FATIGUE
- Conditions
- Lower Limb Injury
- Keywords
- Lower limbs, Physiotherapy, Athlete, Biomechanics, Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Clinica Gema LeonUniversity, hospital or other
- Study start
- 6 Nov 2021 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 22 Dec 2021 (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.
Acute fatigue is the inability to generate a required or expected level of force or exercise intensity, whether or not preceded by previous exercise. It is an important risk factor in overuse injuries. It is multifactorial in nature and its mechanisms of formation are imprecise. This type of fatigue can affect both the peripheral level, generating neuromuscular or peripheral fatigue, and the central level, generating central fatigue Objective: To study several physiotherapeutic protocols, analyzing the degree of effectiveness of each one for the recovery of acute fatigue in athletes. Design: Prospective randomized experimental study with 4 groups of physiotherapeutic protocols suitable in acute fatigue recovery. Participants: Presentation of 80 patients treated with 4 therapeutic protocols, equally divided and purposely sexed. The four protocols were divided into: Active recovery (n=20) hydrotherapy (n=20) massage (n=20) and compression (n=20) for 4 weeks of treatment. Intervention: Active recovery protocols (group 1) hydrotherapy protocol (group 2) massage protocol (group 3) and comprehension protocol (group 4).
Keywords: Lower limbs, physiotherapy, athlete, biomechanics, protocol.
Detailed description
The etiology of injury in sport is multifactorial, generated by both intrinsic and extrinsic factors. There is evidence that supports that the management and handling of loads is the factor that generates the greatest risk of injury and that not respecting the load-recovery balance can lead to an accumulation of fatigue resulting in poor training adaptation which leads to increased risk of injury. From a physiological approach, fatigue is defined as a functional failure of the organism which, due to excessive energy expenditure and depletion of substrates necessary for energy production, leads to a decrease in performance.
Acute fatigue is the inability to generate a required or expected level of exercise force or intensity, whether or not preceded by previous exercise. Acute fatigue is an important risk factor in overuse injuries. It is multifactorial in nature and its mechanisms of formation are imprecise. This type of fatigue can affect both the peripheral level, generating neuromuscular or peripheral fatigue, and the central level, generating central fatigue. Peripheral or neuromuscular fatigue is the result of altered musculoskeletal homeostasis due to a limitation or failure of one or more motor unit processes, producing a dysfunction in the contraction process. Central fatigue is an involuntary failure in brain function or nerve impulse conduction, resulting in impaired transmission from the central nervous system (CNS) and impaired motor axon recruitment. One of the main factors associated with central fatigue is the alteration of synthesis and activity of some neurotransmitters.
Elite athletes push their training to the limit in order to maximize their performance. This generates muscle damage that results in a breakdown of structural proteins of muscle fibers and connective tissues, causing tissue inflammation, Delayed Onset Muscle Soreness (DOMS) and an increase in perceived fatigue. To maximize an athlete's ability to perform, it is not only the training that must be addressed, but also the balance between training and recovery. This prevents maladaptation to physiological and psychological stresses induced by the load. Therefore, it is important for the athlete to optimize the recovery period to reduce the risk of injury.
The purpose of this research is to demonstrate the efficacy of various physiotherapeutic protocols, analyzing the degree of effectiveness in each of these for recovery from acute fatigue in athletes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- 80 patients divided into 4 groups of equal size and randomly selected. The 4 treatment methods used will be as follows: Group 1: Compression techniques (n=20). Group 2: Massage techniques (n=20) Group 3: Hydrotherapy (n=20) Group 4: Active recovery technique (n=20)
| Arm | Type | Receives |
|---|---|---|
| Group 1: Compression technique | Active comparator | Diagnostic Test: State-Trait Anxiety Questionnaire, Diagnostic Test: Rating of Perceived Exertion, Diagnostic Test: Motor coordination tests, Procedure: Physiotherapeutic intervention, Other: Data Analysis20 participants make up the compression technique group. |
| Group 2: Massage techniques | Active comparator | Diagnostic Test: State-Trait Anxiety Questionnaire, Diagnostic Test: Rating of Perceived Exertion, Diagnostic Test: Motor coordination tests, Procedure: Physiotherapeutic intervention, Other: Data Analysis20 participants make up the massage technique group. |
| Group 3: Hydromassage | Active comparator | Diagnostic Test: State-Trait Anxiety Questionnaire, Diagnostic Test: Rating of Perceived Exertion, Diagnostic Test: Motor coordination tests, Procedure: Physiotherapeutic intervention, Other: Data Analysis20 participants make up the hydromassage technique group. |
| Group 4: Active recovery technique. | Active comparator | Diagnostic Test: State-Trait Anxiety Questionnaire, Diagnostic Test: Rating of Perceived Exertion, Diagnostic Test: Motor coordination tests, Procedure: Physiotherapeutic intervention, Other: Data Analysis20 participants make up the active recovery technique group. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Active athletes
- Presentation of typical clinical signs of acute fatigue in one of the two lower limbs
- Positive diagnosis of acute fatigue
Key exclusion criteria (3 listed)
- Not compatible with age range
- Healthy athletes
- Diagnosed injuries other than acute fatigue
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 |
|---|---|---|
| State-Trait Anxiety QuestionnaireAlso: STAIThe scale measures ordinally (1 to 5) the values observed during exposure to anxiety patterns during exercise, such as higher repetitions, greater weight gain or longer exercise duration, as follows: 1. Not at all 2. Little 3. Sometimes 4. Almost always 5. Always | Diagnostic test | Group 1: Compression technique, Group 2: Massage techniques, Group 3: Hydromassage, Group 4: Active recovery technique. |
| Rating of Perceived ExertionAlso: RPEThe scale measures in ordinal form (1 to 6) the perceived effort during the exercise as follows: 1. No pain 2. Little pain 3. Moderate 4. Severe 5. Very strong 6. Unbearable | Diagnostic test | Group 1: Compression technique, Group 2: Massage techniques, Group 3: Hydromassage, Group 4: Active recovery technique. |
| Motor coordination testsThe motor coordination tests are divided into three: 1. Jumping with 2 feet together. 2. Throwing 2 balls from a given distance and space. 3. Proprioception turns | Diagnostic test | Group 1: Compression technique, Group 2: Massage techniques, Group 3: Hydromassage, Group 4: Active recovery technique. |
| Physiotherapeutic interventionParticipants received one session per week, until a total of 20 sessions were completed: Group 1 (n=20) received the muscle compression treatment. Group 2 (n=20) received the manual massage treatment. Group 3 (n=20) received the hydrotherapy treatment and group 4 (n=20) received the active recovery treatment. | Procedure or surgery | Group 1: Compression technique, Group 2: Massage techniques, Group 3: Hydromassage, Group 4: Active recovery technique. |
| Data AnalysisThe usual descriptive parameters (mean and standard deviation) of the sample were calculated. The distribution and analysis of the other data were performed by means of a nonparametric test (Mann-Whitney U test) comparing the groups. A confidence level of 95% was established, considering a value of p<0.05 as statistically significant. | Other | Group 1: Compression technique, Group 2: Massage techniques, Group 3: Hydromassage, Group 4: Active recovery technique. |
Primary outcome
State-Trait Anxiety Questionnaire (STAI)
Time frame: five months
The range or index of anxiety perceived during the exam and the ability to tolerate anxious moments are evaluated.
Rating of Perceived Exertion (RPE)
Time frame: five months
The range or rate of perceived exertion during the scan is evaluated.
Scale Countermovement jump (CMJ)
Time frame: five months
The range or index of neuromuscular performance during the scan is evaluated.
1 secondary outcome
Number of participants in each physical therapy application
Time frame: five months
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 12 Aug 2024.
- Background: PubMed 30659497Benjaminse A, Webster KE, Kimp A, Meijer M, Gokeler A. Revised Approach to the Role of Fatigue in Anterior Cruciate Ligament Injury Prevention: A Systematic Review with Meta-Analyses. Sports Med. 2019 Apr;49(4):565-586. doi: 10.1007/s40279-019-01052-6.
- Background: PubMed 33422109Guan Y, Bredin S, Jiang Q, Taunton J, Li Y, Wu N, Wu L, Warburton D. The effect of fatigue on asymmetry between lower limbs in functional performances in elite child taekwondo athletes. J Orthop Surg Res. 2021 Jan 9;16(1):33. doi: 10.1186/s13018-020-02175-7.
- Background: PubMed 34421641Burton I. Autoregulation in Resistance Training for Lower Limb Tendinopathy: A Potential Method for Addressing Individual Factors, Intervention Issues, and Inadequate Outcomes. Front Physiol. 2021 Aug 5;12:704306. doi: 10.3389/fphys.2021.704306. eCollection 2021.
- Background: PubMed 28979857Trojian T, Driban J, Nuti R, Distefano L, Root H, Nistler C, LaBella C. Osteoarthritis action alliance consensus opinion - best practice features of anterior cruciate ligament and lower limb injury prevention programs. World J Orthop. 2017 Sep 18;8(9):726-734. doi: 10.5312/wjo.v8.i9.726. eCollection 2017 Sep 18.
- Background: PubMed 33761989Franke TPC, Backx FJG, Huisstede BMA. Lower extremity compression garments use by athletes: why, how often, and perceived benefit. BMC Sports Sci Med Rehabil. 2021 Mar 24;13(1):31. doi: 10.1186/s13102-020-00230-8.
- Background: PubMed 30988836Ghram A, Young JD, Soori R, Behm DG. Unilateral Knee and Ankle Joint Fatigue Induce Similar Impairment to Bipedal Balance in Judo Athletes. J Hum Kinet. 2019 Mar 27;66:7-18. doi: 10.2478/hukin-2018-0063. eCollection 2019 Mar.
- Background: PubMed 33086605Cejudo A, Sainz de Baranda P, Ayala F, De Ste Croix M, Santonja-Medina F. Assessment of the Range of Movement of the Lower Limb in Sport: Advantages of the ROM-SPORT I Battery. Int J Environ Res Public Health. 2020 Oct 19;17(20):7606. doi: 10.3390/ijerph17207606.
- Background: PubMed 34475623DeLang MD, Salamh PA, Farooq A, Tabben M, Whiteley R, van Dyk N, Chamari K. The dominant leg is more likely to get injured in soccer players: systematic review and meta-analysis. Biol Sport. 2021 Sep;38(3):397-435. doi: 10.5114/biolsport.2021.100265. Epub 2020 Oct 28.
- Background: PubMed 27587598Gilbert FC, Burdette GT, Joyner AB, Llewellyn TA, Buckley TA. Association Between Concussion and Lower Extremity Injuries in Collegiate Athletes. Sports Health. 2016 Nov/Dec;8(6):561-567. doi: 10.1177/1941738116666509. Epub 2016 Sep 20.
- Background: PubMed 33467385Drury B, Ratel S, Clark CCT, Fernandes JFT, Moran J, Behm DG. Eccentric Resistance Training in Youth: Perspectives for Long-Term Athletic Development. J Funct Morphol Kinesiol. 2019 Nov 28;4(4):70. doi: 10.3390/jfmk4040070.
- Background: PubMed 33064821Mang CS, Whitten TA, Cosh MS, Dukelow SP, Benson BW. Assessment of Postural Stability During an Upper Extremity Rapid, Bimanual Motor Task After Sport-Related Concussion. J Athl Train. 2020 Nov 1;55(11):1160-1173. doi: 10.4085/1062-6050-378-19.
- Background: PubMed 32922630Avedesian JM, Covassin T, Dufek JS. The Influence of Sport-Related Concussion on Lower Extremity Injury Risk: A Review of Current Return-to-Play Practices and Clinical Implications. Int J Exerc Sci. 2020 Aug 1;13(3):873-889. doi: 10.70252/WVYL1782. eCollection 2020.
- Individual participant dataSharing planned: No. The request for the data will be studied and considered upon prior and justified request.
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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.
Gema León Bravo, Physiotherap principal investigator
Gema León Physiotherapy and Rehabilitation Clinic
Rafael Arenas Quiles, Physiotherap study chair
Universidad de Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing State-Trait Anxiety Questionnaire, Rating of Perceived Exertion and Motor coordination tests in people with Lower Limb Injury, run by Clinica Gema Leon 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 3 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: finished, as of the sponsor's last update on 12 Aug 2024. 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?
State-Trait Anxiety Questionnaire (STAI) (time frame: five months). 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 NCT05167162, which also lists 16 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 12 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.