Cumulative Trauma DisordersFMSNCT02091713
Musculoskeletal Injuries' Prediction Tool for Military Combatants in the Israeli Defense Force
An observational study of Cumulative Trauma Disorders, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Emerging evidences indicate that performance on a variety of functional movement screens can identify athletes/soldiers at risk for injury. These field expedient tests have not been validated in a military setting or across different military occupational specialties. Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Cumulative Trauma Disorders
- What is being tested?
- Functional movement screen
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2014to Nov 2016
- Phase
- Observational
- 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 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 300 soldiers in 3 units will be recruited and will undergo medical evaluation and functional movment screening as describes in the protocol.
Who may be able to join
- Ages 18-21 years old
- A combat medical profile according the IDF Medical Corp regulations
- Hebrew speaking and reading.
Who cannot join
- Currently seeking medical care for musculoskeletal injuries or has sought medical care for musculoskeletal injury in the last 30 days.
- Currently unable to participate in routine physical training due to injury in foot, ankle, knee, hip, neck, shoulder, elbow, wrist, or hand injury.
- Cardiac or pulmonary problems limiting physical activity.
- Known history of balance or visual impairment, neurological disorders, or chronic musculoskeletal conditions precluding their involvement in military training, physical training, or sports.
- Pregnancy, subjects that become pregnant during the course of the study will be excluded based on the different injury risk factors that are associated with musculoskeletal injury during pregnancy.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Heller institute of medical research
Tel HaShomer
Oren Schwarz, M.D, +972529283702, Oren.Schwarz@sheba.health.gov.il
Oren Schwarz, M.D
About this study
Official title: Musculoskeletal Injuries' Prediction Tool for Military Combatants in the Israeli Defense Force (FMS)
Emerging evidences indicate that performance on a variety of functional movement screens can identify athletes/soldiers at risk for injury. These field expedient tests have not been validated in a military setting or across different military occupational specialties. In this prospective study the investigators plan to screen 300 combatants for a 1-year time frame in order to validate the suggested algorithm of a list of modifiable and non-modifiable risk factors which are hypothesized to predict injury risk during the military service.
Read the detailed description
Injury data will be collected through physician exam, self-report, profile data, and healthcare utilization data. Injury data will be collected at baseline and for six iterations, every 60 days, over the course of one year following baseline. Based on the data collected, clinical prediction rules will be used to develop computerized algorithm to predict injury risk in these populations. Moreover, these results will assist in creating individualized preventing physical training program.
- Conditions
- Cumulative Trauma Disorders
- Being tested
- Functional movement screen
- Keywords
- FMS, functional movement screen
- Medical subject headings
- Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional movement screenOther
The subjects will undergo movement and balance screens, measures of power, demographic data and biopsychosocial measures. Injury data will be collected through physician exam, self-report, profile data, and healthcare utilization data. Injury data will be collected at baseline and for six iterations, every 60 days, over the course of one year following baseline. Based on the data collected, clinical prediction rules will be used to develop computerized algorithm to predict injury risk in these populations.
| Study group | Role | What they receive |
|---|---|---|
| Experimental/Functional movement screen | 300 subjects from three different combat units will undergo functional movement screening Receives: Other: Functional movement screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline surveillance
In this study all subjects will undergo a baseline assessment on recruitment, in which demographic, biopsychosocial, and physical data will be collected.
Measured: 1 week
Injury surveillance
Yearly injury surveillance will be conducted on a 2-month basis in which the research team will prospectively collect data on any injury occurrence and medical health utilization among the study's subjects.
Measured: 1 year
Secondary outcomes (2)
Physical assessment
The physical assessment of risk factors will include the following 8 tests: foot structure and mobility (foot length, seated and standing AHI), assessment of functional movement (FMS), lower extremity power (SLVJ), hop testing, lower quarter Y-Balance Test (LQYBT), and upper quarter Y Balance test (UQYBT), ankle dorsiflexion, and the 240m shuttle run as detailed.
Measured: 1 year
Demographic and biopsychosocial data
Demographic and biopsychosocial data collection will include general information, such as: age, gender, anthropometrics (height, weight), past medical history previous sport engagements, injury in the last 12 months, past physical activities and levels, smoking status, marital status, and educational level. In addition to these demographic variables all subjects will answer questions related to biopsychosocial factors associated with injury.
This includes questions related to job/life satisfaction, numeric pain ratings associated with depression, anxiety, frustration, anger, and fear, and completion of the patient health questionnaire (PHQ-9) which will help in determining the influence of indicators of depression on future injury risk.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cumulative Trauma DisordersStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Oren Schwarz, Sheba Medical Center
- Investigators
- Oren Schwarz, M.D, Principal investigator, Heller institute of medical research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091713
- Sponsor's protocol ID
- SHEBA-13-0529-BA-CTIL
- Other IDs
- 1294-2013
- Acronym
- FMS
- Status last verified
- Mar 2014
- First submitted
- 12 Mar 2014
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Injuries' Prediction Tool for Military Combatants in the Israeli Defense Force (FMS)
- ClinicalTrials.gov ID
- NCT02091713
- Acronym / sponsor ID
- FMS / SHEBA-13-0529-BA-CTIL
- Conditions
- Cumulative Trauma Disorders
- Keywords
- FMS, functional movement screen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 19 Mar 2014 (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.
Emerging evidences indicate that performance on a variety of functional movement screens can identify athletes/soldiers at risk for injury. These field expedient tests have not been validated in a military setting or across different military occupational specialties. In this prospective study the investigators plan to screen 300 combatants for a 1-year time frame in order to validate the suggested algorithm of a list of modifiable and non-modifiable risk factors which are hypothesized to predict injury risk during the military service.
Detailed description
Injury data will be collected through physician exam, self-report, profile data, and healthcare utilization data. Injury data will be collected at baseline and for six iterations, every 60 days, over the course of one year following baseline. Based on the data collected, clinical prediction rules will be used to develop computerized algorithm to predict injury risk in these populations. Moreover, these results will assist in creating individualized preventing physical training program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental/Functional movement screen | – | Other: Functional movement screen300 subjects from three different combat units will undergo functional movement screening |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 300 soldiers in 3 units will be recruited and will undergo medical evaluation and functional movment screening as describes in the protocol.
Key inclusion criteria (3 listed)
- Ages 18-21 years old
- A combat medical profile according the IDF Medical Corp regulations
- Hebrew speaking and reading.
Key exclusion criteria (5 listed)
- Currently seeking medical care for musculoskeletal injuries or has sought medical care for musculoskeletal injury in the last 30 days.
- Currently unable to participate in routine physical training due to injury in foot, ankle, knee, hip, neck, shoulder, elbow, wrist, or hand injury.
- Cardiac or pulmonary problems limiting physical activity.
- Known history of balance or visual impairment, neurological disorders, or chronic musculoskeletal conditions precluding their involvement in military training, physical training, or sports.
- Pregnancy, subjects that become pregnant during the course of the study will be excluded based on the different injury risk factors that are associated with musculoskeletal injury during pregnancy.
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 |
|---|---|---|
| Functional movement screenThe subjects will undergo movement and balance screens, measures of power, demographic data and biopsychosocial measures. Injury data will be collected through physician exam, self-report, profile data, and healthcare utilization data. Injury data will be collected at baseline and for six iterations, every 60 days, over the course of one year following baseline. Based on the data collected, clinical prediction rules will be used to develop computerized algorithm to predict injury risk in these populations. | Other | Experimental/Functional movement screen |
Primary outcome
Baseline surveillance
Time frame: 1 week
In this study all subjects will undergo a baseline assessment on recruitment, in which demographic, biopsychosocial, and physical data will be collected.
Injury surveillance
Time frame: 1 year
Yearly injury surveillance will be conducted on a 2-month basis in which the research team will prospectively collect data on any injury occurrence and medical health utilization among the study's subjects.
2 secondary outcomes
Physical assessment
Time frame: 1 year
Demographic and biopsychosocial data
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
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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.
Oren Schwarz, M.D principal investigator
Heller institute of medical research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cumulative Trauma Disorders, run by Sheba Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 19 Mar 2014. 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 Israel. 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 Oren Schwarz, M.D (+972529283702, Oren.Schwarz@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline surveillance (time frame: 1 week). 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 19 Mar 2014.