Hip JointNCT03080727
Intraobserver and Interobserver Reproducibility on Hip Clinical Assessment
An observational study of Hip Joint, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
The functional assessment of the hip joint is complex and challenging. Reproducible measures are necessary to identify changes in the structures and functionality of the hip joint over time and to evaluate the outcomes of treatments. A systematic evaluation process is critical to evidence-based practice. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hip Joint
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 13 Apr 2017to 31 Aug 2017
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male healthy subjects
Who may be able to join
- No complaints of pain or knowledge of hip pathology
- Subjects willing to enroll
Who cannot join
- Subjects reporting that they can not perform the tests due to pain
- With previous surgery of the hip or pelvis;
- Diabetes Mellitus;
- Neuromuscular or neurological diseases;
- Cardiovascular diseases that prevent the realization of maximum voluntary effort;
- Subjects presenting positive hip clinical tests
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90690-200
About this study
The functional assessment of the hip joint is complex and challenging. Reproducible measures are necessary to identify changes in the structures and functionality of the hip joint over time and to evaluate the outcomes of treatments. A systematic evaluation process is critical to evidence-based practice. However, there are few studies investigating the reproducibility of these measures such as muscle strength, range of motion (ROM) and hip functionality in healthy subjects.
Read the detailed description
Twenty subjects were randomized in two different days: (1) First evaluation of muscle strength, range of motion and single-leg squat performed by the evaluator 1; (2) Repeat the first evaluation with 3 different evaluators
- Conditions
- Hip Joint
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip muscle strength
Measured with isometric hand hel dynamometry
Measured: Day 1 (evaluator 1) and after 4 days of rest repeat measures on day 2 with 3 different evaluators
Secondary outcomes (1)
Hip range of motion
Measured with goniometer
Measured: Day 1 (evaluator 1) and after 4 days of rest repeat measures on day 2 with 3 different evaluators
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start13 Apr 2017
- Primary completion19 May 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip JointStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Aurélio Vaz, PhD, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080727
- Sponsor's protocol ID
- UFRGS 1.822.689
- Status last verified
- Oct 2017
- First submitted
- 9 Mar 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraobserver and Interobserver Reproducibility on Hip Clinical Assessment
- ClinicalTrials.gov ID
- NCT03080727
- Acronym / sponsor ID
- UFRGS 1.822.689
- Conditions
- Hip Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 19 May 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 15 Mar 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.
The functional assessment of the hip joint is complex and challenging. Reproducible measures are necessary to identify changes in the structures and functionality of the hip joint over time and to evaluate the outcomes of treatments. A systematic evaluation process is critical to evidence-based practice. However, there are few studies investigating the reproducibility of these measures such as muscle strength, range of motion (ROM) and hip functionality in healthy subjects.
Detailed description
Twenty subjects were randomized in two different days: (1) First evaluation of muscle strength, range of motion and single-leg squat performed by the evaluator 1; (2) Repeat the first evaluation with 3 different evaluators
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male healthy subjects
Key inclusion criteria (2 listed)
- No complaints of pain or knowledge of hip pathology
- Subjects willing to enroll
Key exclusion criteria (6 listed)
- Subjects reporting that they can not perform the tests due to pain
- With previous surgery of the hip or pelvis;
- Diabetes Mellitus;
- Neuromuscular or neurological diseases;
- Cardiovascular diseases that prevent the realization of maximum voluntary effort;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hip muscle strength
Time frame: Day 1 (evaluator 1) and after 4 days of rest repeat measures on day 2 with 3 different evaluators
Measured with isometric hand hel dynamometry
1 secondary outcome
Hip range of motion
Time frame: Day 1 (evaluator 1) and after 4 days of rest repeat measures on day 2 with 3 different evaluators
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 26 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hip Joint, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
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 2 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: finished, as of the sponsor's last update on 26 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 1 site in Brazil. 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 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?
Hip muscle strength (time frame: Day 1 (evaluator 1) and after 4 days of rest repeat measures on day 2 with 3 different evaluators). 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 26 Oct 2017; AzTrials last refreshed its copy on 1 Nov 2026.