Sports InjuryNCT04768088
Training of Falling Techniques on Landing Mechanics
A study testing Falling Training in people with Sports Injury and Orthopedic Disorder, run by University of Wyoming at 1 site in United States.
Trial summary
The overall purpose of this study is to quantify the effect and retention of one-week training of falling techniques on landing biomechanics associated with anterior cruciate ligament (ACL) loading compared to soft-landing techniques in young recreational athletes. Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Injury, Orthopedic Disorder, Knee Injuries
- What is being tested?
- Falling Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 31 Dec 2025
- 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 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between 14 and 30 years old.
- Participation in exercise and sports at least two times per week for a total of 2 hours per week.
- Having experience in playing sports that involved jump-landing activities. Sports experience is defined as currently playing sports at least one time per week at the time of testing or having played at high school, college, or club levels.
Who cannot join
- Having had major lower extremity or spinal injuries that have involved surgical treatment.
- Having had an injury that prevented participation in physical activity for more than two weeks over the previous six months.
- Possessing any other conditions that prevent him/her from participating at maximal effort in sporting activities.
- Having had training experience of falling techniques for ACL injury prevention.
- Allergies to adhesives.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wyoming
Laramie, Wyoming, 82070
Boyi Dai, Ph.D., 307-766-5423, bdai@uwyo.edu
Qin Zhu, Ph.D.
About this study
Official title: One-week Training of Falling Techniques on Landing Biomechanics Associated With Anterior Cruciate Ligament Loading
The overall purpose of this study is to quantify the effect and retention of one-week training of falling techniques on landing biomechanics associated with anterior cruciate ligament (ACL) loading compared to soft-landing techniques in young recreational athletes. The secondary purpose is to assess the safety of the training program.
Aim 1: To quantify the effect of one-week training of falling techniques on landing biomechanics during forward, lateral, vertical, and diagonal landings compared to soft-landing techniques. We hypothesize that falling techniques will result in increased knee flexion angles and decreased landing forces, knee abduction and internal rotation angles, and knee moments for all landing directions compared to soft-landing techniques immediately after the training.
Read more
Aim 2: To assess the retention effects of the falling techniques on landing biomechanics compared to soft landings. We hypothesize that the effects of falling techniques on ACL loading variables will be more highly retained compared to soft-landing techniques two weeks after the training.
Aim 3: To identify the safety of the training program. We hypothesize that participants can complete the training without suffering minor, moderate, or major injuries, while occasional minor bruises might be observed.
Read the detailed description
Fifteen male and 15 female recreational athletes between 14 and 17 years old and 15 male and 15 female recreational athletes between 18 and 30 years old will be recruited to complete the study. These age ranges are selected as they show significantly higher injury rates compared to other age ranges and allow us to account for maturational effects. Participants younger than 18 years old will be primarily recruited through local sports clubs. Adult participants will be primarily recruited among the students at the University of Wyoming.
The researchers who will have direct contact with participants will be fully vaccinated against COVID-19 and wear surgical masks. Participants and researchers must pass the Centers for Disease Control and Prevention Facilities COVID-19 Screening prior to each training session and assessment. Participants will be separated by a minimum of 6 feet when multiple participants are trained at the same time. Only one participant will be tested at a time during the assessment. The equipment will be sanitized before and after each use.
Participants will perform one-week training of single-leg falling techniques, a post-training assessment, a two-week break, and a retention assessment. A pre-training assessment will not be performed, and a control group will not be included because it will be unsafe for participants to fall on a hard surface without proper training of falling techniques. The post-training assessment will be performed within three days after the one-week training. The retention assessment will be performed within three days after the two-week break. The one-week falling training will include the forward, lateral, and vertical landing directions and mats with different thicknesses. Participants' landing mechanics will be evaluated during the post-training and retention assessments, which will include the forward, lateral, and vertical landing directions as well as the diagonal landing direction as the novel transfer task. Any injuries that occur during the training and assessments will be documented.
For both post-training and retention assessments, participants will wear spandex clothes and standard running shoes provided by the researchers. After a warm-up protocol, retroreflective markers will be placed on each participants' 7th cervical vertebra and bilateral acromioclavicular joints, greater trochanters, anterior thighs, lateral and medial femoral epicondyles, tibia tuberosities, inferior shanks, lateral and medial malleolus, first toes, first and fifth metatarsal heads, and calcaneus. Motion data will be captured using eight Bonita 10 cameras at 160 Hz (Vicon Motion Systems Ltd, Oxford, U.K.). Ground reaction force data will be measured using one FP4060-10 force platform at 1600 Hz (Bertec Corporation, Columbus, OH, USA). Kinematic and force data will be collected simultaneously by the Vicon Nexus software.
After a static trial, participants will perform a minimum of two practice trials and three recorded trials of single-leg soft landings and falling in the forward, lateral, vertical, and diagonal directions. The forward and vertical directions were included in our previous study. The lateral direction is added to increase the challenges associated with the frontal plane to load the knee. The diagonal direction is incorporated as the transfer task, which imposes challenges to both the sagittal and frontal planes as a more complex movement. The order of the testing legs (left or right), landing directions (forward, lateral, vertical, or diagonal,), and landing techniques (soft-landing or falling techniques) will be randomized. A 0.5-inch mat with minimal effects of impact absorption will cover the concrete floor for the falling conditions.
A lower extremity model will be established to calculate the three-dimensional internal knee joint resultant moments using the inverse dynamic approach and three-dimensional knee joint angles characterized by the Cardan angles as previously described. The independent variables are the two landing techniques (soft-landing and falling) and two assessments (post-training and retention). For each landing direction and each leg, each landing variable will be compared among the two landing techniques and two assessments using repeated-measures analysis of variables (ANOVA). Significant interactions of ANOVA will be followed by pairwise comparisons.
- Being tested
- Falling Training
- Keywords
- Biomechanics, Sports Medicine, Knee, Injury Prevention, ACL
- Medical subject headings
- Athletic Injuries, Musculoskeletal Diseases, Knee Injuries, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Falling TrainingOther
For the falling training, participants will be instructed to initially land softly with increased knee and hip flexion and then smoothly fall to the direction of the movement while transferring the weight from the feet to the hands and subsequently to the lateral trunk and hip. The training program includes three one-hour training sessions over a week with one or two days between two sessions. Each training session will begin with a warm-up protocol. Participants will progressively increase the task difficulty and decrease the thickness of the mat. For each training session, participants will perform a minimum of one successful practice trial for each task difficulty and each landing direction on the thicker mat and then complete a minimum of three successful practice trials for each task difficulty and landing direction on the thinner mat. The last training session involves falling on a 0.5-inch mat, which is the same as the surface for the post-training and retention assessments.
| Study group | Role | What they receive |
|---|---|---|
| One-week training of falling techniques on landing biomechanics associated with ACL loading | Experimental | Participants will perform one-week training of single-leg falling techniques, a post-training assessment, a two-week break, and a retention assessment. Receives: Other: Falling Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak vertical ground reaction forces during landings
Increases in this variable have been shown to be associated with increased ACL loading
Measured: Immediate after the training
Peak vertical ground reaction forces during landings
Increases in this variable have been shown to be associated with increased ACL loading
Measured: Two weeks after the training
Secondary outcomes (12)
Peak knee flexion angles during landings
Decreases in this variable have been shown to be associated with increased ACL loading
Measured: Immediate after the training
Peak knee flexion angles during landings
Decreases in this variable have been shown to be associated with increased ACL loading
Measured: Two weeks after the training
Peak knee abduction angles during landings
Decreases in this variable have been shown to be associated with increased ACL loading
Measured: Immediate after the training
Peak knee abduction angles during landings
Decreases in this variable have been shown to be associated with increased ACL loading
Measured: Two weeks after the training
Peak knee internal rotation angles during landings
Decreases in this variable have been shown to be associated with increased ACL loading
Measured: Immediate after the training
Peak knee internal rotation angles during landings
Decreases in this variable have been shown to be associated with increased ACL loading
Measured: Two weeks after the training
Peak internal knee extension moments during landings
Decreases in this variable have been shown to be associated with increased ACL loading
Measured: Immediate after the training
Peak internal knee extension moments during landings
Decreases in this variable have been shown to be associated with increased ACL loading
Measured: Two weeks after the training
Peak internal knee adduction moments during landings
Decreases in this variable have been shown to be associated with increased ACL loading
Measured: Immediate after the training
Peak internal knee adduction moments during landings
Decreases in this variable have been shown to be associated with increased ACL loading
Measured: Two weeks after the training
Peak internal knee external rotation moments during landings
Decreases in this variable have been shown to be associated with increased ACL loading
Measured: Immediate after the training
Peak internal knee external rotation moments during landings
Decreases in this variable have been shown to be associated with increased ACL loading
Measured: Two weeks after the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will perform one-week training of single-leg falling techniques, a post-training assessment, a two-week break, and a retention assessment. A pre-training assessment will not be performed, and a control group will not be included because it will be unsafe for participants to fall on a hard surface without proper training of falling techniques.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wyoming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boyi Dai, Ph.D., Principal investigator, University of Wyoming
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768088
- Sponsor's protocol ID
- 20210219BD02958
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only data that has been anonymized will be shared. Electronic data will be archived to the University of Wyoming Digital Repository (http://uwdigital.uwyo.edu/). All data in the repository will also receive a unique DOI (digital object identifier). The DOI function as a hyperlink and will always refer to that specific dataset.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-week Training of Falling Techniques on Landing Biomechanics Associated With Anterior Cruciate Ligament Loading
- ClinicalTrials.gov ID
- NCT04768088
- Acronym / sponsor ID
- 20210219BD02958
- Keywords
- Biomechanics, Sports Medicine, Knee, Injury Prevention, ACL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of WyomingUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Feb 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.
The overall purpose of this study is to quantify the effect and retention of one-week training of falling techniques on landing biomechanics associated with anterior cruciate ligament (ACL) loading compared to soft-landing techniques in young recreational athletes. The secondary purpose is to assess the safety of the training program.
Aim 1: To quantify the effect of one-week training of falling techniques on landing biomechanics during forward, lateral, vertical, and diagonal landings compared to soft-landing techniques. We hypothesize that falling techniques will result in increased knee flexion angles and decreased landing forces, knee abduction and internal rotation angles, and knee moments for all landing directions compared to soft-landing techniques immediately after the training.
Aim 2: To assess the retention effects of the falling techniques on landing biomechanics compared to soft landings. We hypothesize that the effects of falling techniques on ACL loading variables will be more highly retained compared to soft-landing techniques two weeks after the training.
Aim 3: To identify the safety of the training program. We hypothesize that participants can complete the training without suffering minor, moderate, or major injuries, while occasional minor bruises might be observed.
Detailed description
Fifteen male and 15 female recreational athletes between 14 and 17 years old and 15 male and 15 female recreational athletes between 18 and 30 years old will be recruited to complete the study. These age ranges are selected as they show significantly higher injury rates compared to other age ranges and allow us to account for maturational effects. Participants younger than 18 years old will be primarily recruited through local sports clubs. Adult participants will be primarily recruited among the students at the University of Wyoming.
The researchers who will have direct contact with participants will be fully vaccinated against COVID-19 and wear surgical masks. Participants and researchers must pass the Centers for Disease Control and Prevention Facilities COVID-19 Screening prior to each training session and assessment. Participants will be separated by a minimum of 6 feet when multiple participants are trained at the same time. Only one participant will be tested at a time during the assessment. The equipment will be sanitized before and after each use.
Participants will perform one-week training of single-leg falling techniques, a post-training assessment, a two-week break, and a retention assessment. A pre-training assessment will not be performed, and a control group will not be included because it will be unsafe for participants to fall on a hard surface without proper training of falling techniques. The post-training assessment will be performed within three days after the one-week training. The retention assessment will be performed within three days after the two-week break. The one-week falling training will include the forward, lateral, and vertical landing directions and mats with different thicknesses. Participants' landing mechanics will be evaluated during the post-training and retention assessments, which will include the forward, lateral, and vertical landing directions as well as the diagonal landing direction as the novel transfer task. Any injuries that occur during the training and assessments will be documented.
For both post-training and retention assessments, participants will wear spandex clothes and standard running shoes provided by the researchers. After a warm-up protocol, retroreflective markers will be placed on each participants' 7th cervical vertebra and bilateral acromioclavicular joints, greater trochanters, anterior thighs, lateral and medial femoral epicondyles, tibia tuberosities, inferior shanks, lateral and medial malleolus, first toes, first and fifth metatarsal heads, and calcaneus. Motion data will be captured using eight Bonita 10 cameras at 160 Hz (Vicon Motion Systems Ltd, Oxford, U.K.). Ground reaction force data will be measured using one FP4060-10 force platform at 1600 Hz (Bertec Corporation, Columbus, OH, USA). Kinematic and force data will be collected simultaneously by the Vicon Nexus software.
After a static trial, participants will perform a minimum of two practice trials and three recorded trials of single-leg soft landings and falling in the forward, lateral, vertical, and diagonal directions. The forward and vertical directions were included in our previous study. The lateral direction is added to increase the challenges associated with the frontal plane to load the knee. The diagonal direction is incorporated as the transfer task, which imposes challenges to both the sagittal and frontal planes as a more complex movement. The order of the testing legs (left or right), landing directions (forward, lateral, vertical, or diagonal,), and landing techniques (soft-landing or falling techniques) will be randomized. A 0.5-inch mat with minimal effects of impact absorption will cover the concrete floor for the falling conditions.
A lower extremity model will be established to calculate the three-dimensional internal knee joint resultant moments using the inverse dynamic approach and three-dimensional knee joint angles characterized by the Cardan angles as previously described. The independent variables are the two landing techniques (soft-landing and falling) and two assessments (post-training and retention). For each landing direction and each leg, each landing variable will be compared among the two landing techniques and two assessments using repeated-measures analysis of variables (ANOVA). Significant interactions of ANOVA will be followed by pairwise comparisons.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will perform one-week training of single-leg falling techniques, a post-training assessment, a two-week break, and a retention assessment. A pre-training assessment will not be performed, and a control group will not be included because it will be unsafe for participants to fall on a hard surface without proper training of falling techniques.
| Arm | Type | Receives |
|---|---|---|
| One-week training of falling techniques on landing biomechanics associated with ACL loading | Experimental | Other: Falling TrainingParticipants will perform one-week training of single-leg falling techniques, a post-training assessment, a two-week break, and a retention assessment. |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Between 14 and 30 years old.
- Participation in exercise and sports at least two times per week for a total of 2 hours per week.
- Having experience in playing sports that involved jump-landing activities. Sports experience is defined as currently playing sports at least one time per week at the time of testing or having played at high school, college, or club levels.
Key exclusion criteria (6 listed)
- Having had major lower extremity or spinal injuries that have involved surgical treatment.
- Having had an injury that prevented participation in physical activity for more than two weeks over the previous six months.
- Possessing any other conditions that prevent him/her from participating at maximal effort in sporting activities.
- Having had training experience of falling techniques for ACL injury prevention.
- Allergies to adhesives.
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 |
|---|---|---|
| Falling TrainingFor the falling training, participants will be instructed to initially land softly with increased knee and hip flexion and then smoothly fall to the direction of the movement while transferring the weight from the feet to the hands and subsequently to the lateral trunk and hip. The training program includes three one-hour training sessions over a week with one or two days between two sessions. Each training session will begin with a warm-up protocol. Participants will progressively increase the task difficulty and decrease the thickness of the mat. For each training session, participants will perform a minimum of one successful practice trial for each task difficulty and each landing direction on the thicker mat and then complete a minimum of three successful practice trials for each task difficulty and landing direction on the thinner mat. The last training session involves falling on a 0.5-inch mat, which is the same as the surface for the post-training and retention assessments. | Other | One-week training of falling techniques on landing biomechanics associated with ACL loading |
Primary outcome
Peak vertical ground reaction forces during landings
Time frame: Immediate after the training
Increases in this variable have been shown to be associated with increased ACL loading
Peak vertical ground reaction forces during landings
Time frame: Two weeks after the training
Increases in this variable have been shown to be associated with increased ACL loading
12 secondary outcomes
Peak knee flexion angles during landings
Time frame: Immediate after the training
Peak knee flexion angles during landings
Time frame: Two weeks after the training
Peak knee abduction angles during landings
Time frame: Immediate after the training
Peak knee abduction angles during landings
Time frame: Two weeks after the training
Peak knee internal rotation angles during landings
Time frame: Immediate after the training
Peak knee internal rotation angles during landings
Time frame: Two weeks after the training
Peak internal knee extension moments during landings
Time frame: Immediate after the training
Peak internal knee extension moments during landings
Time frame: Two weeks after the training
Peak internal knee adduction moments during landings
Time frame: Immediate after the training
Peak internal knee adduction moments during landings
Time frame: Two weeks after the training
Peak internal knee external rotation moments during landings
Time frame: Immediate after the training
Peak internal knee external rotation moments during landings
Time frame: Two weeks after the training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: Yes. Only data that has been anonymized will be shared. Electronic data will be archived to the University of Wyoming Digital Repository (http://uwdigital.uwyo.edu/). All data in the repository will also receive a unique DOI (digital object identifier). The DOI function as a hyperlink and will always refer to that specific dataset.
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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.
Boyi Dai, Ph.D. principal investigator
University of Wyoming
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Falling Training in people with Sports Injury and Orthopedic Disorder, run by University of Wyoming at 1 site in United States.
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 6 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 24 Feb 2021. 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 United States. 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 Boyi Dai, Ph.D. (3077665423, bdai@uwyo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak vertical ground reaction forces during landings (time frame: Immediate after the training). The study lists 2 primary outcomes in all. 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 24 Feb 2021.