NCT06820346

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 5, 2025

Last Update Submit

February 5, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    15 seconds for each evaluation (day 1)

Secondary Outcomes (1)

  • Pelvis rotation during hip adduction evaluation

    15 seconds for each evaluation (day 1)

Study Arms (1)

Healthy adults

EXPERIMENTAL

Manual and instrumental evaluation of hip adduction

Other: Manual and instrumental evaluation of hip adduction

Interventions

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.

Healthy adults

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects

You may not qualify if:

  • absence of symptomatic lower limb conditions that could impede measurement, such as ligament injuries of the knee or degenerative joint diseases of the hip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spine Center

Bologna, Bologna, 40128, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 11, 2025

Study Start

October 1, 2022

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations