Healthy2MOTNCT06820346
New Manual Test for Hip Abductor Extensibility
A study testing Manual and instrumental evaluation of hip adduction in people with Healthy, run by Manusapiens at 1 site in Italy.
Trial summary
This pilot study aims to evaluate the precision and accuracy of a new manual test for assessing hip abductor extensibility. The iliotibial band (ITB) and hip abductor muscles play a crucial role in lower limb biomechanics, and their flexibility is commonly assessed using the Ober test. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Manual and instrumental evaluation of hip adduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 1 Mar 2023
- 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
- healthy subjects
Who cannot join
- absence of symptomatic lower limb conditions that could impede measurement, such as ligament injuries of the knee or degenerative joint diseases of the hip
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Manual Test for the Assessment of Hip Abductor Extensibility: a Pilot Study on Precision and Accuracy
This pilot study aims to evaluate the precision and accuracy of a new manual test for assessing hip abductor extensibility. The iliotibial band (ITB) and hip abductor muscles play a crucial role in lower limb biomechanics, and their flexibility is commonly assessed using the Ober test. However, the Ober test has limitations, including excessive pelvic movement and reliance on qualitative evaluation. This study introduces and validates a novel manual test designed to improve the accuracy and reliability of hip abductor extensibility assessment.
The primary objective is to determine the intra-rater and inter-rater reliability of the new test, measured using the intraclass correlation coefficient (ICC). The secondary objective is to compare the test's accuracy against an inertial motion sensor system and to quantify pelvic movement during the new test. To provide a comparative measure of pelvic motion, a subgroup of participants will also undergo the modified Ober test.
Read more
Forty healthy participants (20 males and 20 females) aged 18 to 30 years will be recruited. Each participant will undergo the new test, performed by two independent raters. A subset of participants will also be evaluated using the modified Ober test to assess differences in pelvic movement. Inertial sensors will be used to measure hip adduction angles and pelvic motion. Statistical analyses will include ICC calculations for reliability and paired t-tests to compare pelvic movement between the tests.
This study aims to establish a more precise and objective method for evaluating hip abductor extensibility, which may enhance clinical assessment and management of conditions associated with iliotibial band tension.
Read the detailed description
This study aims to evaluate the reliability and accuracy of a new manual test for assessing iliotibial band (ITB) tension. The current standard for ITB extensibility assessment, the modified Ober test, presents limitations such as excessive pelvic movement and qualitative evaluation. The newly proposed test seeks to address these issues by minimizing extraneous movement and providing a more controlled and reproducible measurement of hip adduction.
Study Design The study follows a repeated-measures design, where intra-rater and inter-rater reliability are the primary outcomes, measured using the intraclass correlation coefficient (ICC). Secondary outcomes include the accuracy of the new test compared to an inertial motion sensor and an analysis of pelvic movement during the new test versus the modified Ober test in a subset of participants.
Participants A total of 40 healthy adults (20 males and 20 females), aged between 18 and 30 years, were recruited. The only exclusion criterion was the presence of symptomatic lower limb conditions that could interfere with the measurement, such as ligament injuries or degenerative joint diseases. No additional selection criteria were imposed, as existing literature does not categorize ITB extensibility based on age, sex, or pathology.
New Test Execution
The new test was originally proposed by Colonna (2012) and is designed to provide a more reliable and precise measurement of ITB tension. The test procedure consists of the following steps:
- Patient Positioning: The patient lies supine on the edge of a treatment table, with the non-tested leg flexed at the hip and knee, stabilizing the pelvis by resting the lateral malleolus against the table edge. The tested leg remains extended.
- Operator Positioning: The operator stands on the opposite side of the tested leg, stabilizing the knee of the non-tested leg with one hand and grasping the ankle of the tested leg with the other.
- Hip Adduction: The tested leg is gently adducted until a determined resistance is felt or the patient reports discomfort, ensuring no pain occurs.
- Measurement: The hip adduction angle is visually assessed and assigned a degree value.
This procedure is designed to enhance measurement accuracy by providing a clear and stable reference point while reducing the risk of excessive pelvic movement.
Modified Ober Test Execution A subset of participants underwent the modified Ober test for comparison. The patient lay on the side with the lower leg flexed at the hip and knee, while the upper leg remained extended. The therapist stabilized the pelvis while abducting and extending the hip, then allowing passive adduction. A goniometer was used to obtain quantitative measurements of hip adduction angles. The modified Ober test was chosen over the classic Ober test as it reduces the influence of knee flexors and patellar tension, providing a more specific assessment of ITB extensibility.
Phases of the Study
The study was conducted in six phases:
- Agreement on Measurement Methodology: Standardization of the new test and the modified Ober test procedures.
- Recruitment: Participants were enrolled at the OSCE (Osteopathic Spine Center Education) school of osteopathy in Bologna, Italy.
- Training Phase: Operators practiced test execution using a goniometer and dynamometer (100N force standardization), validated their visual assessments with inertial sensors, and refined their technique.
- Preliminary Testing for Agreement: Ten participants underwent preliminary tests to confirm measurement consistency.
- Official Data Collection: Each operator conducted the new test on both lower limbs of each participant at two time points (T0 and T1), with a minimum four-hour interval. The modified Ober test was performed on 20 participants by one operator for pelvic movement comparison.
- Data Analysis: Reliability and accuracy of the new test were assessed by comparing results to the modified Ober test and inertial sensor data.
Measurement Instruments
- Hip adduction angles and pelvic rotation were measured using Xsens® inertial sensors. These wireless sensors, placed on the pelvis and thigh, provided real-time kinematic data to validate the accuracy of visual assessments and quantify pelvic movement.
Statistical Analysis
Data were analyzed using SPSS software. Reliability was assessed using ICC values, interpreted as follows:
Below 0.5: Poor reliability 0.5 to 0.75: Moderate reliability 0.75 to 0.9: Good reliability Above 0.9: Excellent reliability Accuracy of the new test was determined by comparing operator assessments with inertial sensor data. Paired t-tests were used to compare pelvic movement between the new test and the modified Ober test, with statistical significance set at p < 0.05.
By addressing the limitations of the modified Ober test, this study seeks to introduce a more precise and clinically applicable method for assessing ITB extensibility.
- Conditions
- Healthy
- Being tested
- Manual and instrumental evaluation of hip adduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual and instrumental evaluation of hip adductionOther
The intervention consists of a new manual test for assessing iliotibial band (ITB) tension and hip abductor extensibility. The patient lies supine on the edge of a treatment table with the non-tested leg flexed at the hip and knee, stabilizing the pelvis. The tested leg remains extended. The examiner stabilizes the non-tested leg with one hand and adducts the tested leg until a resistance is felt, ensuring no pain. The hip adduction angle is visually assessed and recorded. A subset of participants also undergoes the modified Ober test for comparison. Inertial motion sensors are used to validate the accuracy of visual assessments. The primary outcomes include intra-rater and inter-rater reliability, while secondary outcomes evaluate the test's accuracy and pelvic movement reduction.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Experimental | Manual and instrumental evaluation of hip adduction Receives: Other: Manual and instrumental evaluation of hip adduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precison of visual hip adduction evaluation
intra-day concordance intra and inter examiners of the visual identification of the degrees of hip adduction by means of intraclass correlation coefficient
Measured: 15 seconds for each evaluation (day 1)
Accuracy of visual hip adduction evaluation
Concordance intra-day between the visual and instrumental evaluation of the degrees of hip adduction. The instrumental data are obtained using a Xsens inertial sensors, which measure hip adduction angles. The sensor is placed on the shank of the tested leg, providing objective kinematic data. The concordance between the two methods is evaluated with the intraclass correlation coefficient.
Measured: 15 seconds for each evaluation (day 1)
Secondary outcomes (1)
Pelvis rotation during hip adduction evaluation
Degrees of pelvis rotation during hip adduction evaluation measured with Xsens inertial sensors, both during the new test and the modified Ober test. The average values will be compared.
Measured: 15 seconds for each evaluation (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Oct 2022
- Primary completion1 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manusapiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820346
- Sponsor's protocol ID
- 2MOT
- Acronym
- 2MOT
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Manual Test for the Assessment of Hip Abductor Extensibility: a Pilot Study on Precision and Accuracy
- ClinicalTrials.gov ID
- NCT06820346
- Acronym / sponsor ID
- 2MOT / 2MOT
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ManusapiensUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 11 Feb 2025 (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.
This pilot study aims to evaluate the precision and accuracy of a new manual test for assessing hip abductor extensibility. The iliotibial band (ITB) and hip abductor muscles play a crucial role in lower limb biomechanics, and their flexibility is commonly assessed using the Ober test. However, the Ober test has limitations, including excessive pelvic movement and reliance on qualitative evaluation. This study introduces and validates a novel manual test designed to improve the accuracy and reliability of hip abductor extensibility assessment.
The primary objective is to determine the intra-rater and inter-rater reliability of the new test, measured using the intraclass correlation coefficient (ICC). The secondary objective is to compare the test's accuracy against an inertial motion sensor system and to quantify pelvic movement during the new test. To provide a comparative measure of pelvic motion, a subgroup of participants will also undergo the modified Ober test.
Forty healthy participants (20 males and 20 females) aged 18 to 30 years will be recruited. Each participant will undergo the new test, performed by two independent raters. A subset of participants will also be evaluated using the modified Ober test to assess differences in pelvic movement. Inertial sensors will be used to measure hip adduction angles and pelvic motion. Statistical analyses will include ICC calculations for reliability and paired t-tests to compare pelvic movement between the tests.
This study aims to establish a more precise and objective method for evaluating hip abductor extensibility, which may enhance clinical assessment and management of conditions associated with iliotibial band tension.
Detailed description
This study aims to evaluate the reliability and accuracy of a new manual test for assessing iliotibial band (ITB) tension. The current standard for ITB extensibility assessment, the modified Ober test, presents limitations such as excessive pelvic movement and qualitative evaluation. The newly proposed test seeks to address these issues by minimizing extraneous movement and providing a more controlled and reproducible measurement of hip adduction.
Study Design The study follows a repeated-measures design, where intra-rater and inter-rater reliability are the primary outcomes, measured using the intraclass correlation coefficient (ICC). Secondary outcomes include the accuracy of the new test compared to an inertial motion sensor and an analysis of pelvic movement during the new test versus the modified Ober test in a subset of participants.
Participants A total of 40 healthy adults (20 males and 20 females), aged between 18 and 30 years, were recruited. The only exclusion criterion was the presence of symptomatic lower limb conditions that could interfere with the measurement, such as ligament injuries or degenerative joint diseases. No additional selection criteria were imposed, as existing literature does not categorize ITB extensibility based on age, sex, or pathology.
New Test Execution
The new test was originally proposed by Colonna (2012) and is designed to provide a more reliable and precise measurement of ITB tension. The test procedure consists of the following steps:
- Patient Positioning: The patient lies supine on the edge of a treatment table, with the non-tested leg flexed at the hip and knee, stabilizing the pelvis by resting the lateral malleolus against the table edge. The tested leg remains extended.
- Operator Positioning: The operator stands on the opposite side of the tested leg, stabilizing the knee of the non-tested leg with one hand and grasping the ankle of the tested leg with the other.
- Hip Adduction: The tested leg is gently adducted until a determined resistance is felt or the patient reports discomfort, ensuring no pain occurs.
- Measurement: The hip adduction angle is visually assessed and assigned a degree value.
This procedure is designed to enhance measurement accuracy by providing a clear and stable reference point while reducing the risk of excessive pelvic movement.
Modified Ober Test Execution A subset of participants underwent the modified Ober test for comparison. The patient lay on the side with the lower leg flexed at the hip and knee, while the upper leg remained extended. The therapist stabilized the pelvis while abducting and extending the hip, then allowing passive adduction. A goniometer was used to obtain quantitative measurements of hip adduction angles. The modified Ober test was chosen over the classic Ober test as it reduces the influence of knee flexors and patellar tension, providing a more specific assessment of ITB extensibility.
Phases of the Study
The study was conducted in six phases:
- Agreement on Measurement Methodology: Standardization of the new test and the modified Ober test procedures.
- Recruitment: Participants were enrolled at the OSCE (Osteopathic Spine Center Education) school of osteopathy in Bologna, Italy.
- Training Phase: Operators practiced test execution using a goniometer and dynamometer (100N force standardization), validated their visual assessments with inertial sensors, and refined their technique.
- Preliminary Testing for Agreement: Ten participants underwent preliminary tests to confirm measurement consistency.
- Official Data Collection: Each operator conducted the new test on both lower limbs of each participant at two time points (T0 and T1), with a minimum four-hour interval. The modified Ober test was performed on 20 participants by one operator for pelvic movement comparison.
- Data Analysis: Reliability and accuracy of the new test were assessed by comparing results to the modified Ober test and inertial sensor data.
Measurement Instruments
- Hip adduction angles and pelvic rotation were measured using Xsens® inertial sensors. These wireless sensors, placed on the pelvis and thigh, provided real-time kinematic data to validate the accuracy of visual assessments and quantify pelvic movement.
Statistical Analysis
Data were analyzed using SPSS software. Reliability was assessed using ICC values, interpreted as follows:
Below 0.5: Poor reliability 0.5 to 0.75: Moderate reliability 0.75 to 0.9: Good reliability Above 0.9: Excellent reliability Accuracy of the new test was determined by comparing operator assessments with inertial sensor data. Paired t-tests were used to compare pelvic movement between the new test and the modified Ober test, with statistical significance set at p < 0.05.
By addressing the limitations of the modified Ober test, this study seeks to introduce a more precise and clinically applicable method for assessing ITB extensibility.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | Experimental | Other: Manual and instrumental evaluation of hip adductionManual and instrumental evaluation of hip adduction |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (1 listed)
- absence of symptomatic lower limb conditions that could impede measurement, such as ligament injuries of the knee or degenerative joint diseases of the hip
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 |
|---|---|---|
| Manual and instrumental evaluation of hip adductionThe intervention consists of a new manual test for assessing iliotibial band (ITB) tension and hip abductor extensibility. The patient lies supine on the edge of a treatment table with the non-tested leg flexed at the hip and knee, stabilizing the pelvis. The tested leg remains extended. The examiner stabilizes the non-tested leg with one hand and adducts the tested leg until a resistance is felt, ensuring no pain. The hip adduction angle is visually assessed and recorded. A subset of participants also undergoes the modified Ober test for comparison. Inertial motion sensors are used to validate the accuracy of visual assessments. The primary outcomes include intra-rater and inter-rater reliability, while secondary outcomes evaluate the test's accuracy and pelvic movement reduction. | Other | Healthy adults |
Primary outcome
Precison of visual hip adduction evaluation
Time frame: 15 seconds for each evaluation (day 1)
intra-day concordance intra and inter examiners of the visual identification of the degrees of hip adduction by means of intraclass correlation coefficient
Accuracy of visual hip adduction evaluation
Time frame: 15 seconds for each evaluation (day 1)
Concordance intra-day between the visual and instrumental evaluation of the degrees of hip adduction. The instrumental data are obtained using a Xsens inertial sensors, which measure hip adduction angles. The sensor is placed on the shank of the tested leg, providing objective kinematic data. The concordance between the two methods is evaluated with the intraclass correlation coefficient.
1 secondary outcome
Pelvis rotation during hip adduction evaluation
Time frame: 15 seconds for each evaluation (day 1)
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 11 Feb 2025.
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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?
A study testing Manual and instrumental evaluation of hip adduction in people with Healthy, run by Manusapiens at 1 site in Italy.
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 1 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 11 Feb 2025. 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 Italy. 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?
Precison of visual hip adduction evaluation (time frame: 15 seconds for each evaluation (day 1)). 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 11 Feb 2025; AzTrials last refreshed its copy on 31 Oct 2026.