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Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males

Primary Purpose

Femoroacetabular Impingement

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Reliability of 3D motion analysis protocol
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Femoroacetabular Impingement focused on measuring 3D motion analysis, Reliability

Eligibility Criteria

12 Years - 35 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Group 1: adolescent males aged 12-16 years old
  • Group 2: adult males aged 25-35 years old

Exclusion Criteria:

- Volunteers who received major prior surgery of the lower limbs or with any pathology, injury or disorder known to affect the locomotor system

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Adolescent volunteers

Adult volunteers

Arm Description

Adolescent males aged 12-16 years old

Adult males aged 25-35 years old

Outcomes

Primary Outcome Measures

Kinematic parameters in order for reliability
The construction of all kinematic measurements in order for reliability using 3D motion analysis

Secondary Outcome Measures

Copenhagen Hip and Groin Outcome Score (HAGOS)
The assessment of symptoms, activity limitations, participation restrictions and QOL in physically active, young to middle-aged patients with long-standing hip and/or groin pain
International Hip Outcome Tool (IHOT)
To obtaine subjective measures of symptoms, as well as determining emotional and social health status

Full Information

First Posted
March 16, 2021
Last Updated
March 29, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04822571
Brief Title
Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males
Official Title
Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Femoroacetabular impingement is an orthopedic condition that is primarily characterized by the presence of anatomic bony abnormalities in the femoral head and/or the acetabulum resulting in an abnormal contact between the two during hip motion, especially in positions of increased hip flexion and rotation, ultimately leading to hip pain. The main study was initiated with the goal of exploring the etiology of FAI in a multidimensional and novel way that addresses the major gaps in literature. Within the main study a 3D motion capture protocol has been designed in line with the latest literature recommendations, which called for more hip ROM specific movements and athlete oriented 3D motion capture protocols that incorporate the spinopelvic complex. While the protocol surely contains movements that have been previously validated and published such as squats and lunges, a unique addition of high velocity soccer kicks and hop- lunges have been included. Such additions elevate the relevancy of the 3D motion analysis protocol, however they also pose questions on how reliable and accurate these additions are. This is especially important a 3D motion analysis has a very subjective component, which is the placement of the skin markers by the clinician. Errors or alteration to markers placement between different sessions or different subjects have been shown to significantly affect the quality of data. Furthermore, not all physical movement can be properly documented using motion analysis. The velocity at which the movement is preformed combined with how complex it is can affect the quality of data collected by the motion analysis system. Also another important component is the uniqueness of the population recruited for the main study. Most studies with highly dynamic motion protocols have been validated and published on adult populations. Thus the investigators cannot use their findings liberally to compare with the adolescent protocol, as differences in patterns of motion between adults and adolescence have been documented. Indeed, a need to test the reliability of the investigators' protocol among their own study groups is highly imperative.
Detailed Description
Femoroacetabular impingement is an orthopedic condition that is primarily characterized by the presence of anatomic bony abnormalities in the femoral head and/or the acetabulum resulting in an abnormal contact between the two during hip motion, especially in positions of increased hip flexion and rotation, ultimately leading to hip pain. FAI can be radiologically classified into 3 types of morphology: Pincer, CAM and mixed type. Pincer morphology is mainly characterized on radiological films by an over-coverage of the acetabulum, has a high center edge angle and is seen in females more frequently. CAM morphology is characterized by an increase in bone formation at the femoral head-neck junction and is mainly identified by a large alpha angle on medical imaging scans. Unlike pincer, CAM morphology occurs mainly in males. Mixed morphology is a third type of FAI and consists of a combination of both CAM and pincer impingement characteristics. FAI has been increasingly garnering attention in the last two decades due to two main reasons. The first reason is its recognition as a leading cause of hip pain in the young economically-active adult. Epidemiological reports show the average age of FAI patients is 28 years old. Furthermore, a significant number of FAI patients are athletes who have professional careers that heavily depend on their physical wellbeing. The second reason FAI has been in the spotlight of orthopedic research recently, is the growing evidence linking it to early cartilage and labral damage, and subsequently to the development of hip osteoarthritis (OA). Ganz and colleagues were the first to make this link and assumed that the presence of the inter-articular morphological abnormality leads to abutment of the femoral head-neck junction against the acetabular rim. This repeated mechanical abutment is assumed to then lead to acetabular labral damage and progressive breakdown of the chondrolabral junction, thereby leading to chondral defects and the eventual onset of OA. Hip OA by itself is an acknowledged source of pain/disability and is associated with an ever-increasing socioeconomic cost. A recent systematic review on the prevalence of symptomatic hip morphology reported the prevalence of CAM type deformity to be 37%; the prevalence of pincer deformity was 67% in the general population. Interestingly, there was an almost 3:1 ratio of CAM deformity in an athletic population compared with non-athletes. This was not the case for pincer deformity. Furthermore, such morphological findings are increasingly being reported in the adolescent athletic population specifically. A number of recent studies found a markedly higher prevalence of cam deformities in asymptomatic adolescents participating in, specifically, soccer, ice-hockey and basketball as compared with their non-athlete controls. Such reports have led researchers to speculate whether participating in high intensity physical activity at the critical period of bone maturation prior to femoral physis closure (10 - 15 years of age) could cause CAM deformity post femoral physis closure (15 -18 years of age old). It is hypothesized that a CAM in this population could form either due to new bone formation at the anterosuperior head-neck junction, or be induced by changes in the shape of the growth plate due to high shear forces acting on the growing hip during these athletic activities. However, as of date there is no concrete evidence to support this hypothesis. Consequently, the reasons behind the formations of CAM deformity in adolescent athletes remain unclear and call for further research. Such research is imperative to increase our understanding of the effect high training load can have on the wellbeing and long term health of young athletes. It is with this background in mind that the main study was initiated with the goal of exploring the etiology of FAI in a multidimensional and novel way that addresses the major gaps in literature. Within the main study a 3D motion capture protocol has been designed in line with the latest literature recommendations, which called for more hip ROM specific movements and athlete oriented 3D motion capture protocols that incorporate the spinopelvic complex. While the protocol surely contains movements that have been previously validated and published such as squats and lunges, a unique addition of high velocity soccer kicks and hop- lunges have been included. Such additions elevate the relevancy of the 3D motion analysis protocol, however they also pose questions on how reliable and accurate these additions are. This is especially important a 3D motion analysis has a very subjective component, which is the placement of the skin markers by the clinician. Errors or alteration to markers placement between different sessions or different subjects have been shown to significantly affect the quality of data. Furthermore, not all physical movement can be properly documented using motion analysis. The velocity at which the movement is preformed combined with how complex it is can affect the quality of data collected by the motion analysis system. Also another important component is the uniqueness of the population recruited for the main study. Most studies with highly dynamic motion protocols have been validated and published on adult populations. Thus the investigators cannot use their findings liberally to compare with the adolescent protocol, as differences in patterns of motion between adults and adolescence have been documented. Indeed, a need to test the reliability of the investigators' protocol among their own study groups is highly imperative.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement
Keywords
3D motion analysis, Reliability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adolescent volunteers
Arm Type
Other
Arm Description
Adolescent males aged 12-16 years old
Arm Title
Adult volunteers
Arm Type
Other
Arm Description
Adult males aged 25-35 years old
Intervention Type
Other
Intervention Name(s)
Reliability of 3D motion analysis protocol
Intervention Description
The intrinsic and extrinsic reliability of the designed 3D motion analysis protocol is measured in cases of high velocity dynamic movement such as kicking a soccer ball.
Primary Outcome Measure Information:
Title
Kinematic parameters in order for reliability
Description
The construction of all kinematic measurements in order for reliability using 3D motion analysis
Time Frame
within a time interval of 1 month
Secondary Outcome Measure Information:
Title
Copenhagen Hip and Groin Outcome Score (HAGOS)
Description
The assessment of symptoms, activity limitations, participation restrictions and QOL in physically active, young to middle-aged patients with long-standing hip and/or groin pain
Time Frame
within a time interval of 1 month
Title
International Hip Outcome Tool (IHOT)
Description
To obtaine subjective measures of symptoms, as well as determining emotional and social health status
Time Frame
within a time interval of 1 month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Group 1: adolescent males aged 12-16 years old Group 2: adult males aged 25-35 years old Exclusion Criteria: - Volunteers who received major prior surgery of the lower limbs or with any pathology, injury or disorder known to affect the locomotor system
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stijn Ghijselings
Phone
+3216338825
Email
stijn.ghijselings@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Lennart Scheys
Phone
+3216340885
Email
lennart.scheys@uzleuven.be
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Investigating the Reliability of Highly Dynamic 3D Motion Analysis Protocol in Adolescence and Adult Males

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