Athletic InjuriesNCT02727049
Motion Capture and Analysis of NYIT Athletes
A study testing Osteopathic manipulative medicine (OMM) in people with Athletic Injuries, run by New York Institute of Technology at 2 sites in United States.
Trial summary
The purpose of this research is to: 1. determine the normal or existing dynamic biomechanics of college athletes and 2. test the effectiveness of osteopathic manipulative medicine in the treatment of athletic injuries. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Injuries
- What is being tested?
- Osteopathic manipulative medicine (OMM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to Oct 2017
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- athlete at new York Institute of Technology
- approval by NYIT Athletics Physical for participation in sports
- no current injury
Who cannot join
- illness preventing participation in sports
- any current injury
- younger than 18 years of age
- pregnancy
- allergy to spandex, nylon, or polyester
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York Institute of Technology College of Osteopathic Medicine Academic Health Care Center
Old Westbury, New York, 11568
New York Institute of Technology
Old Westbury, New York, 11568
About this study
The purpose of this research is to:
- determine the normal or existing dynamic biomechanics of college athletes and
- test the effectiveness of osteopathic manipulative medicine in the treatment of athletic injuries.
Motion capture using Vicon systems allows researchers to quantify characteristics of a body such as the range of motion of the hip or shoulder during an athletic technique such as kicking or shooting a basketball into the basket. The quantified information has been used before to better understand human mobility and performance. Osteopathic manipulative medicine (OMM) is manual medicine applied to joints, muscles, and connective tissue with a goal of improved body functions. Research demonstrating effectiveness of OMM on the musculoskeletal and associated connective tissue systems health includes, among others, prospective clinical trials of OMM for treatment of neck pain, low back pain, and acute first- and second-degree ankle sprains.
Read the detailed description
Volunteers for the study will be recruited through their Athletic director, coach, or physician by an announcement made verbally or via email. The motion capture will be performed under Matthew Cornelius, MS using the Vicon Bonita Motion Capture system in the Fine Arts Department of NYIT. Following the motion capture, body biomechanics will be analyzed to determine the range of motion of each joint in sagittal, frontal, and horizontal planes as well as the timing and sequence of the movements. The motion analysis will be compared to the Sports Physical exam, including the general, structural/neuromusculoskeletal, and central neurological (ImPACT) exams. The comparison will add validity to the physical exam. In addition, determining if the quantitative, 3-dimensional motion analysis can be correlated with information from the physical exam with regards to restrictions to motion may be useful for athletes to optimize their abilities in the future. If during the course of the athlete's training and competition season s/he sustains an injury, s/he will be evaluated by the NYIT athletics physician, who will randomly assign the injured athletes to either the 'standard of care without OMM' or 'standard of care with OMM' cohorts when medically appropriate. OMM will be performed by an NYITCOM physician specializing in family medicine and OMT or neuromusculoskeletal systems and OMM. "Return to play' time and post-intervention/post-control quantitative motion analysis of biomechanics during the athletes demonstration of the same athletic maneuvers as before the injury.
- Conditions
- Athletic Injuries
- Being tested
- Osteopathic manipulative medicine (OMM)
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative medicine (OMM)Other
Also called osteopathic manual therapy
Osteopathic manipulative medicine includes all types of manual therapies to gently restore and/or optimize one's natural joint, muscle, and other soft tissue balance.
| Study group | Role | What they receive |
|---|---|---|
| injured athlete for OMM | Experimental | Participating athletes who sustain an injury will receive standard of care with the Intervention osteopathic manipulative medicine (OMM) Receives: Other: Osteopathic manipulative medicine (OMM) |
| injured athlete no OMM | No intervention | Participating athletes who sustain an injury will receive standard of care withOUT osteopathic manipulative medicine (OMM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in joint angles (degrees)
quantitative biomechanical testing will be performed before and after OMM or control
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startFeb 2015
- Primary completionOct 2017
- Study completionOct 2017
Why it stopped: no college athlete availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic InjuriesStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayme D Mancini, DO PhD, Principal investigator, New York Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727049
- Sponsor's protocol ID
- BHS1064
- Status last verified
- Oct 2017
- First submitted
- 12 Feb 2015
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Capture and Analysis of NYIT Athletes
- ClinicalTrials.gov ID
- NCT02727049
- Acronym / sponsor ID
- BHS1064
- Conditions
- Athletic Injuries
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no college athlete availability
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 4 Apr 2016 (estimated)
- 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 purpose of this research is to:
- determine the normal or existing dynamic biomechanics of college athletes and
- test the effectiveness of osteopathic manipulative medicine in the treatment of athletic injuries.
Motion capture using Vicon systems allows researchers to quantify characteristics of a body such as the range of motion of the hip or shoulder during an athletic technique such as kicking or shooting a basketball into the basket. The quantified information has been used before to better understand human mobility and performance. Osteopathic manipulative medicine (OMM) is manual medicine applied to joints, muscles, and connective tissue with a goal of improved body functions. Research demonstrating effectiveness of OMM on the musculoskeletal and associated connective tissue systems health includes, among others, prospective clinical trials of OMM for treatment of neck pain, low back pain, and acute first- and second-degree ankle sprains.
Detailed description
Volunteers for the study will be recruited through their Athletic director, coach, or physician by an announcement made verbally or via email. The motion capture will be performed under Matthew Cornelius, MS using the Vicon Bonita Motion Capture system in the Fine Arts Department of NYIT. Following the motion capture, body biomechanics will be analyzed to determine the range of motion of each joint in sagittal, frontal, and horizontal planes as well as the timing and sequence of the movements. The motion analysis will be compared to the Sports Physical exam, including the general, structural/neuromusculoskeletal, and central neurological (ImPACT) exams. The comparison will add validity to the physical exam. In addition, determining if the quantitative, 3-dimensional motion analysis can be correlated with information from the physical exam with regards to restrictions to motion may be useful for athletes to optimize their abilities in the future. If during the course of the athlete's training and competition season s/he sustains an injury, s/he will be evaluated by the NYIT athletics physician, who will randomly assign the injured athletes to either the 'standard of care without OMM' or 'standard of care with OMM' cohorts when medically appropriate. OMM will be performed by an NYITCOM physician specializing in family medicine and OMT or neuromusculoskeletal systems and OMM. "Return to play' time and post-intervention/post-control quantitative motion analysis of biomechanics during the athletes demonstration of the same athletic maneuvers as before the injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injured athlete for OMM | Experimental | Other: Osteopathic manipulative medicine (OMM)Participating athletes who sustain an injury will receive standard of care with the Intervention osteopathic manipulative medicine (OMM) |
| injured athlete no OMM | No intervention | –Participating athletes who sustain an injury will receive standard of care withOUT osteopathic manipulative medicine (OMM) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- athlete at new York Institute of Technology
- approval by NYIT Athletics Physical for participation in sports
- no current injury
Key exclusion criteria (5 listed)
- illness preventing participation in sports
- any current injury
- younger than 18 years of age
- pregnancy
- allergy to spandex, nylon, or polyester
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 |
|---|---|---|
| Osteopathic manipulative medicine (OMM)Also: osteopathic manual therapyOsteopathic manipulative medicine includes all types of manual therapies to gently restore and/or optimize one's natural joint, muscle, and other soft tissue balance. | Other | injured athlete for OMM |
Primary outcome
change in joint angles (degrees)
Time frame: 1 year
quantitative biomechanical testing will be performed before and after OMM or control
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- 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.
Jayme D Mancini, DO PhD principal investigator
New York Institute of Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manipulative medicine (OMM) in people with Athletic Injuries, run by New York Institute of Technology at 2 sites 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 5 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: withdrawn, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
change in joint angles (degrees) (time frame: 1 year). 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 12 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.