Single Leg Squat PerformanceNCT03203083
Single Leg Squat Performance in Physically and Non-physically Active Individuals
An observational study of Single Leg Squat Performance and Athletic Injuries, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
Trial summary
Single-leg squat (SLS) is a functional test visually rated by clinicians for assessing lower limb function as a preventive injury strategy. SLS clinical rating is a qualitative evaluation and it does not count objective outcomes as kinematics data and surface electromyography (sEMG) assessment. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Single Leg Squat Performance, Athletic Injuries
- What is being tested?
- performance of the single leg squat task
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 19 Mar 2014to Jul 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A cohort of healthy young subjects was recruited.
Who may be able to join
- body mass index (BMI) between 18.5-25.5,
- age between 18-35 years old,
- written informed consent to participate,
Who cannot join
- musculoskeletal pain or history of lower extremity injuries lasting more than three months
About this study
Official title: Single Leg Squat Performance in Physically and Non-physically Active Individuals: a Cross-sectional Study
Single-leg squat (SLS) is a functional test visually rated by clinicians for assessing lower limb function as a preventive injury strategy. SLS clinical rating is a qualitative evaluation and it does not count objective outcomes as kinematics data and surface electromyography (sEMG) assessment. Based on the SLS rating, the aims of this study were (i) to determine the clinical rating agreement among six raters and (ii) to assess kinematic and sEMG predictors of good SLS performance in physically and non-physically active individuals.
- Conditions
- Single Leg Squat Performance, Athletic Injuries
- Being tested
- performance of the single leg squat task
- Keywords
- Reproducibility of Results, Clinical Assessment
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
performance of the single leg squat taskOther
Also called clinical assessment
The single-leg squat (SLS) is a clinical functional test commonly used to evaluate clinical abnormal movement patterns of the lower limbs in terms of kinetic chain or co-ordinating muscle activity. This scale accounts for the assessment of five dimensions: overall impression, trunk posture, pelvis in space, hip joint motion and knee join motion. The SLS is potentially promising as a functional test since it involves both daily activity and athletic task.
| Study group | Role | What they receive |
|---|---|---|
| physically active individuals | subjects who perform sports activities more than 6 hours per week Receives: Other: performance of the single leg squat task | |
| non-physically active individuals | subjects who perform less than 2 hours per week of sport activities Receives: Other: performance of the single leg squat task |
What is being measured
The primary outcome is the main question the study is designed to answer.
reliability of the clinical assessment
intra- and inter-rater reliability for six clinicians when performing the SLS clinical rating assessment
Measured: Baseline
reliability of the clinical assessment
intra- and inter-rater reliability for six clinicians when performing the SLS clinical rating assessment
Measured: 2 weeks after the first evaluation
reliability of the clinical assessment
intra- and inter-rater reliability for six clinicians when performing the SLS clinical rating
Measured: 1 month after the first evaluation
Secondary outcomes (2)
kinematic predictors
The following kinematic variables were considered during the single-leg squat: ipsilateral hip flexion in the lateral plane, hip internal rotation, hip adduction, pelvic obliquity, knee flexion (lateral plane) and medio-lateral displacement (frontal plane).
Measured: Baseline
sEMG predictors
The surface Electromyography (sEMG) activity of the following muscles were assessed: tensor fasciae latae, rectus femoris, adductor longus, gluteus maximus and transversus abdominis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start19 Mar 2014
- Primary completion3 Jul 2014
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Single Leg Squat PerformanceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203083
- Sponsor's protocol ID
- Core Stability L3017
- Status last verified
- Jun 2017
- First submitted
- 21 Jun 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gianola S, Castellini G, Stucovitz E, Nardo A, Banfi G. Single leg squat performance in physically and non-physically active individuals: a cross-sectional study. BMC Musculoskelet Disord. 2017 Jul 14;18(1):299. doi: 10.1186/s12891-017-1660-8.
PubMed 28709418
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Leg Squat Performance in Physically and Non-physically Active Individuals: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03203083
- Acronym / sponsor ID
- Core Stability L3017
- Conditions
- Single Leg Squat Performance, Athletic Injuries
- Keywords
- Reproducibility of Results, Clinical Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 19 Mar 2014 (actual)
- Primary completion
- 3 Jul 2014 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 29 Jun 2017 (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.
Single-leg squat (SLS) is a functional test visually rated by clinicians for assessing lower limb function as a preventive injury strategy. SLS clinical rating is a qualitative evaluation and it does not count objective outcomes as kinematics data and surface electromyography (sEMG) assessment. Based on the SLS rating, the aims of this study were (i) to determine the clinical rating agreement among six raters and (ii) to assess kinematic and sEMG predictors of good SLS performance in physically and non-physically active individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physically active individuals | – | Other: performance of the single leg squat tasksubjects who perform sports activities more than 6 hours per week |
| non-physically active individuals | – | Other: performance of the single leg squat tasksubjects who perform less than 2 hours per week of sport activities |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A cohort of healthy young subjects was recruited.
Key inclusion criteria (3 listed)
- body mass index (BMI) between 18.5-25.5,
- age between 18-35 years old,
- written informed consent to participate,
Key exclusion criteria (1 listed)
- musculoskeletal pain or history of lower extremity injuries lasting more than three months
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 |
|---|---|---|
| performance of the single leg squat taskAlso: clinical assessmentThe single-leg squat (SLS) is a clinical functional test commonly used to evaluate clinical abnormal movement patterns of the lower limbs in terms of kinetic chain or co-ordinating muscle activity. This scale accounts for the assessment of five dimensions: overall impression, trunk posture, pelvis in space, hip joint motion and knee join motion. The SLS is potentially promising as a functional test since it involves both daily activity and athletic task. | Other | non-physically active individuals, physically active individuals |
Primary outcome
reliability of the clinical assessment
Time frame: Baseline
intra- and inter-rater reliability for six clinicians when performing the SLS clinical rating assessment
reliability of the clinical assessment
Time frame: 2 weeks after the first evaluation
intra- and inter-rater reliability for six clinicians when performing the SLS clinical rating assessment
reliability of the clinical assessment
Time frame: 1 month after the first evaluation
intra- and inter-rater reliability for six clinicians when performing the SLS clinical rating
2 secondary outcomes
kinematic predictors
Time frame: Baseline
sEMG predictors
Time frame: Baseline
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 29 Jun 2017.
- Derived from this study: PubMed 28709418Gianola S, Castellini G, Stucovitz E, Nardo A, Banfi G. Single leg squat performance in physically and non-physically active individuals: a cross-sectional study. BMC Musculoskelet Disord. 2017 Jul 14;18(1):299. doi: 10.1186/s12891-017-1660-8.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Single Leg Squat Performance and Athletic Injuries, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
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 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
reliability of the clinical assessment (time frame: Baseline). 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 NCT03203083, which also lists 1 linked publication.
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 29 Jun 2017.