Injury LegNCT04748718
Serial Movement Assessment in Collegiate Athletes Who Perform Injury Prevention Training
A study testing Exercise-based injury prevention program in people with Injury Leg and Injury, Knee, run by Northern Vermont University at 1 site in United States.
Trial summary
Athletic injury can result in decreased athletic performance or removal from sport participation. There may also be psychological and financial impacts of athletic injury. Additionally, there can be long-term consequences, such as increased risk of subsequent injury or arthritis. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury Leg, Injury, Knee, Injury;Sports
- What is being tested?
- Exercise-based injury prevention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2021to 29 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- National Collegiate Athletics Association (NCAA) Division III Athlete
- Coach and athletic trainer elect to receive injury prevention services
- Ages 18-24
Who cannot join
- -Does not participate on NCAA Division III Athletic Team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serial Movement Assessment in Athletes Who Perform Injury Prevention Training
Athletic injury can result in decreased athletic performance or removal from sport participation. There may also be psychological and financial impacts of athletic injury. Additionally, there can be long-term consequences, such as increased risk of subsequent injury or arthritis. Therefore, determining ways to prevent athletic injury from occurring is critical. Movement quality during sport is related to injury risk. Athletes who move poorly are generally at increased risk of injury compared to athletes who move well. Movement quality can be improved through exercise-based injury prevention training, thereby decreasing injury risk. This purposed of this study is to evaluate movement quality multiple times over the course of an athletic season in collegiate athletes who perform injury prevention training. The hypothesis is that movement quality will improve over the course of an athletic season.
Read the detailed description
Neuromuscular control, or quality of movement, during sport is related to injury risk. Athletes who move poorly are generally at increased risk of injury compared to athletes who move well. Neuromuscular control can be improved through exercise-based injury prevention training (called preventive training programs, or PTPs), thereby decreasing injury risk. Neuromuscular control is dynamic and therefore should be evaluated regularly; however, no study has serially evaluated neuromuscular control in athletes who perform PTPs. The overall objective of the proposed study is to longitudinally evaluate multiple aspects of neuromuscular control (i.e., movement quality, balance) across several time points during a single athletic season in collegiate athletes who perform PTPs. Therefore, two specific aims are proposed: Specific Aim 1: Evaluate neuromuscular control at multiple time points during an athletic season in collegiate athletes who perform PTPs. Specific Aim 2: Evaluate multiple measures of neuromuscular control over the course of an athletic season in collegiate athletes who perform PTPs. A field-based, experimental, cohort study will be used to address both specific aims. Subjects will be recruited from NCAA-Division III men's and women's soccer, volleyball and basketball teams. Neuromuscular control will be assessed four times during the athletic season using the Landing Error Scoring System (LESS), the Balance Error Scoring System (BESS), and the Star Excursion Balance Test (SEBT). The LESS evaluates movement quality, while the BESS and the SEBT evaluate static and dynamic balance, respectively. Subjects will perform PTPs for about 10 minutes/day, at least 4 days/week.
- Conditions
- Injury Leg, Injury, Knee, Injury;Sports, Injury, Ankle
- Being tested
- Exercise-based injury prevention program
- Keywords
- sport injury, injury prevention, neuromuscular control
- Medical subject headings
- Leg Injuries, Knee Injuries, Athletic Injuries, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-based injury prevention programOther
~10-minute, 4+ times/week exercise-based injury prevention program. Includes flexibility, strengthening, balance, agility and plyometric exercises.
| Study group | Role | What they receive |
|---|---|---|
| Injury Prevention Arm | Experimental | exercise-based neuromuscular training injury prevention program Receives: Other: Exercise-based injury prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Landing Error Scoring System (LESS) Score
number of errors; scale is 0-17; lower score indicates better outcome
Measured: assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)
Balance Error Scoring System (BESS) Score
number of errors; scale is 0-60; higher score indicates worse outcome
Measured: assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start17 Aug 2021
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Injury LegStudies 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
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Vermont University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleanor Beltz, Northern Vermont University
- Investigators
- Eleanor Beltz, PhD, ATC, Principal investigator, Northern Vermont University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748718
- Sponsor's protocol ID
- Beltz FAW2122 NMC PTP
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2021
- Last updated
- 1 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Movement Assessment in Athletes Who Perform Injury Prevention Training
- ClinicalTrials.gov ID
- NCT04748718
- Acronym / sponsor ID
- Beltz FAW2122 NMC PTP
- Conditions
- Injury Leg, Injury, Knee, Injury;Sports, Injury, Ankle
- Keywords
- sport injury, injury prevention, neuromuscular control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Northern Vermont UniversityUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Posted 1 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Athletic injury can result in decreased athletic performance or removal from sport participation. There may also be psychological and financial impacts of athletic injury. Additionally, there can be long-term consequences, such as increased risk of subsequent injury or arthritis. Therefore, determining ways to prevent athletic injury from occurring is critical. Movement quality during sport is related to injury risk. Athletes who move poorly are generally at increased risk of injury compared to athletes who move well. Movement quality can be improved through exercise-based injury prevention training, thereby decreasing injury risk. This purposed of this study is to evaluate movement quality multiple times over the course of an athletic season in collegiate athletes who perform injury prevention training. The hypothesis is that movement quality will improve over the course of an athletic season.
Detailed description
Neuromuscular control, or quality of movement, during sport is related to injury risk. Athletes who move poorly are generally at increased risk of injury compared to athletes who move well. Neuromuscular control can be improved through exercise-based injury prevention training (called preventive training programs, or PTPs), thereby decreasing injury risk. Neuromuscular control is dynamic and therefore should be evaluated regularly; however, no study has serially evaluated neuromuscular control in athletes who perform PTPs. The overall objective of the proposed study is to longitudinally evaluate multiple aspects of neuromuscular control (i.e., movement quality, balance) across several time points during a single athletic season in collegiate athletes who perform PTPs. Therefore, two specific aims are proposed: Specific Aim 1: Evaluate neuromuscular control at multiple time points during an athletic season in collegiate athletes who perform PTPs. Specific Aim 2: Evaluate multiple measures of neuromuscular control over the course of an athletic season in collegiate athletes who perform PTPs. A field-based, experimental, cohort study will be used to address both specific aims. Subjects will be recruited from NCAA-Division III men's and women's soccer, volleyball and basketball teams. Neuromuscular control will be assessed four times during the athletic season using the Landing Error Scoring System (LESS), the Balance Error Scoring System (BESS), and the Star Excursion Balance Test (SEBT). The LESS evaluates movement quality, while the BESS and the SEBT evaluate static and dynamic balance, respectively. Subjects will perform PTPs for about 10 minutes/day, at least 4 days/week.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injury Prevention Arm | Experimental | Other: Exercise-based injury prevention programexercise-based neuromuscular training injury prevention program |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- National Collegiate Athletics Association (NCAA) Division III Athlete
- Coach and athletic trainer elect to receive injury prevention services
- Ages 18-24
Key exclusion criteria (1 listed)
- -Does not participate on NCAA Division III Athletic Team
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 |
|---|---|---|
| Exercise-based injury prevention program~10-minute, 4+ times/week exercise-based injury prevention program. Includes flexibility, strengthening, balance, agility and plyometric exercises. | Other | Injury Prevention Arm |
Primary outcome
Landing Error Scoring System (LESS) Score
Time frame: assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)
number of errors; scale is 0-17; lower score indicates better outcome
Balance Error Scoring System (BESS) Score
Time frame: assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)
number of errors; scale is 0-60; higher score indicates worse outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Eleanor Beltz, PhD, ATC principal investigator
Northern Vermont 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 Exercise-based injury prevention program in people with Injury Leg and Injury, Knee, run by Northern Vermont University 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 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 1 Apr 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 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?
Yes. Results are posted in the registry (first posted 1 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Landing Error Scoring System (LESS) Score (time frame: assessing change over 3 timepoints: baseline (week 0), midseason (weeks 4-6), end-of-season (weeks 10-12)). 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 1 Apr 2024.