Development; UnilateralAsymTenNCT03128814
The Degree, Development and Interrelationship of Structural and Functional Asymmetry in (Pre)Adolescent Elite Tennis Players
An observational study of Development; Unilateral, run by Laurent Chapelle at 1 site in Belgium.
Trial summary
Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven loading, this gradually results in structural (e.g. increased bone and muscle mass) and functional (e.g. increased strength) adaptations to the dominant side of the body. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Development; Unilateral
- How many people
- 240 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2017to 31 Jan 2022
- 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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Young elite tennis players enrolled in Belgian high-performance tennis academies as well as age- and gender-matched (within two months) controls.
Who may be able to join
- Being enrolled in a Belgian high-performance tennis academy
Who cannot join
- Injury at the start of the data collection, any known musculoskeletal abnormality, developmental disorder or metabolic disease.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Physical Education and Physical Therapy
Brussels, 1050
Laurent Chapelle, MSc, +32477472756, laurent.chapelle@vub.ac.be
About this study
Official title: The Degree, Development and Interrelationship of Structural and Functional Asymmetry in (Pre)Adolescent Elite Tennis Players: A Prospective Cohort Study With a Link to Growth and Maturation, Technical Skill Performance and Whole Body Injury
Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven loading, this gradually results in structural (e.g. increased bone and muscle mass) and functional (e.g. increased strength) adaptations to the dominant side of the body. The corresponding structural and functional asymmetry can be further accentuated by (intensively) practicing a unilateral sport such as tennis, which is very popular. Yet, research on this particular topic is scarce, especially in (pre)adolescent players. Existing studies, which often face methodological shortcomings (e.g. crosssectional designs, small sample sizes, no link to field methods), mainly focus on adults and structural asymmetry of the upper extremity itself, with very little or no attention to whole body structural as well as functional asymmetry. Moreover, the link of both forms of asymmetry with growth and maturation, everyday locomotion, technical skill performance and whole body injury is currently not (fully) understood. Therefore, the main purpose of this research project is to gain comprehensive knowledge on the degree, development and implications of both structural and functional asymmetry during a critical period in life using a longitudinal approach. As such, this project among youth elite tennis players will provide insights on the extent to which structural and/or functional asymmetry is acceptable for being most successful but remaining injury free.
- Conditions
- Development; Unilateral
- Keywords
- Tennis, Asymmetry, Structural, Functional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elite (pre)adolescent tennis players | Not described | |
| Age- and gender-matched controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometry
Stature (cm) Sitting height (cm) Upper- and lower extremity length (cm) body weight (kg) Body Mass Index (kg/m²) Age at Peak height Velocity (years) Skeletal muscle mass (kg)
These values will be determined every two months during a maximum period of three years, expressed as mean and standard deviation and will be used to develop growth charts and velocity curves.
Measured: September 2017 - December 2020
Body composition
Dual X-Ray Absorptiometry
- lean mass (g)
- fat mass (g)
- bone mass (g)
- total bone area (cm²)
- Bone Mineral Content (g)
- Bone Mineral Density (g/cm²)
Circumferences - upper and lower arm, thigh and calf (in cm)
Ultrasound
- Muscle thickness ((in mm) of M. Biceps, M. Triceps, M. Rectus Abdominis, Quadriceps and Hamstrings)
Bioelectric impedance
- fat (g)
- fat free mass (g)
These outcome measures will be determined on both the dominant and the non-dominant extremity/side every six months during a maximum period of three years. The side-to-side difference will be calculated using the symmetry index (see outcome measure 4). Every outcome measure described above will be expressed as mean and standard deviation for both the dominant and non-dominant extremity/side
Measured: September 2017 - December 2020
Functional test battery
Strength and Power:
- Seated shot put functional test (distance in cm)
- Grip Strength (kg)
- Unilateral countermovement jump (distance in cm)
- Single hop test (distance in cm)
- Medicine Ball throws (distance in cm)
Speed and Agility:
- Plate tapping (time s)
- Single leg 6-m hop test (time in s)
Balance and Flexibility:
- Upper- and Lower extremity Y-balance test (distance in cm)
- Standing On One Leg with Eyes Closed (time in s)
Motor control and Coordination:
- Unilateral hand wall toss test (score in points)
- 270 degrees tap test (time in s)
Locomotion pattern:
- Ground Reaction Forces (force in N)
Every test will be performed unilaterally for both the dominant and non-dominant extremity/side every six months during a maximum period of three years. The side-to-side difference will be calculated using the symmetry index (see outcome measure 4). The mean (plus standard deviation) of every test (dominant and non-dominant test score) will be reported
Measured: September 2017 - December 2020
Structural and functional asymmetry index
Side-to-side difference (i.e. dominant vs non-dominant extremity/side) will be calculated and expressed as a percentage (extremity symmetry index (%)) for the outcome measures described above (anthropometry, body composition and functional test battery) using following formula:
((measure dominant extremity/measure non-dominant extremity)-1) x 100
Measured: September 2017 - December 2020
Secondary outcomes (2)
Injury incidence
Injury incidence in young elite tennis players (patterns and occurence) will be recorded and reported continuously for a maximum period of three years.
Measured: September 2017 - December 2020
Technical tennis skills performance
technical skill of young elite tennis players. - Technical skill performance will be examined by means of video analysis once a year and scored by an independent expert panel. Mean technical ability will be reported.
Tennis specific performance:
- Tennis players will perform the Dutch Technical-Tactical Tennis Test (D4T) once a year. The mean test score will be reported.
Measured: September 2017 - December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 Sep 2017 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development; UnilateralStudies 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
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laurent Chapelle
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laurent Chapelle, Vrije Universiteit Brussel
- Investigators
- Peter Clarys, PhD, Study director, Vrije Universiteit BrusselEva D'Hondt, PhD, Study director, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128814
- Sponsor's protocol ID
- Asymmetry in tennis
- Acronym
- AsymTen
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2017
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared or will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Degree, Development and Interrelationship of Structural and Functional Asymmetry in (Pre)Adolescent Elite Tennis Players: A Prospective Cohort Study With a Link to Growth and Maturation, Technical Skill Performance and Whole Body Injury
- ClinicalTrials.gov ID
- NCT03128814
- Acronym / sponsor ID
- AsymTen / Asymmetry in tennis
- Conditions
- Development; Unilateral
- Keywords
- Tennis, Asymmetry, Structural, Functional
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Laurent ChapelleUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 25 Apr 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.
Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven loading, this gradually results in structural (e.g. increased bone and muscle mass) and functional (e.g. increased strength) adaptations to the dominant side of the body. The corresponding structural and functional asymmetry can be further accentuated by (intensively) practicing a unilateral sport such as tennis, which is very popular. Yet, research on this particular topic is scarce, especially in (pre)adolescent players. Existing studies, which often face methodological shortcomings (e.g. crosssectional designs, small sample sizes, no link to field methods), mainly focus on adults and structural asymmetry of the upper extremity itself, with very little or no attention to whole body structural as well as functional asymmetry. Moreover, the link of both forms of asymmetry with growth and maturation, everyday locomotion, technical skill performance and whole body injury is currently not (fully) understood. Therefore, the main purpose of this research project is to gain comprehensive knowledge on the degree, development and implications of both structural and functional asymmetry during a critical period in life using a longitudinal approach. As such, this project among youth elite tennis players will provide insights on the extent to which structural and/or functional asymmetry is acceptable for being most successful but remaining injury free.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elite (pre)adolescent tennis players | – | – |
| Age- and gender-matched controls | – | – |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Young elite tennis players enrolled in Belgian high-performance tennis academies as well as age- and gender-matched (within two months) controls.
Key inclusion criteria (1 listed)
- Being enrolled in a Belgian high-performance tennis academy
Key exclusion criteria (1 listed)
- Injury at the start of the data collection, any known musculoskeletal abnormality, developmental disorder or metabolic disease.
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
Anthropometry
Time frame: September 2017 - December 2020
Stature (cm) Sitting height (cm) Upper- and lower extremity length (cm) body weight (kg) Body Mass Index (kg/m²) Age at Peak height Velocity (years) Skeletal muscle mass (kg) These values will be determined every two months during a maximum period of three years, expressed as mean and standard deviation and will be used to develop growth charts and velocity curves.
Body composition
Time frame: September 2017 - December 2020
Dual X-Ray Absorptiometry * lean mass (g) * fat mass (g) * bone mass (g) * total bone area (cm²) * Bone Mineral Content (g) * Bone Mineral Density (g/cm²) Circumferences - upper and lower arm, thigh and calf (in cm) Ultrasound - Muscle thickness ((in mm) of M. Biceps, M. Triceps, M. Rectus Abdominis, Quadriceps and Hamstrings) Bioelectric impedance * fat (g) * fat free mass (g) These outcome measures will be determined on both the dominant and the non-dominant extremity/side every six months during a maximum period of three years. The side-to-side difference will be calculated using the symmetry index (see outcome measure 4). Every outcome measure described above will be expressed as mean and standard deviation for both the dominant and non-dominant extremity/side
Functional test battery
Time frame: September 2017 - December 2020
Strength and Power: * Seated shot put functional test (distance in cm) * Grip Strength (kg) * Unilateral countermovement jump (distance in cm) * Single hop test (distance in cm) * Medicine Ball throws (distance in cm) Speed and Agility: * Plate tapping (time s) * Single leg 6-m hop test (time in s) Balance and Flexibility: * Upper- and Lower extremity Y-balance test (distance in cm) * Standing On One Leg with Eyes Closed (time in s) Motor control and Coordination: * Unilateral hand wall toss test (score in points) * 270 degrees tap test (time in s) Locomotion pattern: - Ground Reaction Forces (force in N) Every test will be performed unilaterally for both the dominant and non-dominant extremity/side every six months during a maximum period of three years. The side-to-side difference will be calculated using the symmetry index (see outcome measure 4). The mean (plus standard deviation) of every test (dominant and non-dominant test score) will be reported
Structural and functional asymmetry index
Time frame: September 2017 - December 2020
Side-to-side difference (i.e. dominant vs non-dominant extremity/side) will be calculated and expressed as a percentage (extremity symmetry index (%)) for the outcome measures described above (anthropometry, body composition and functional test battery) using following formula: ((measure dominant extremity/measure non-dominant extremity)-1) x 100
2 secondary outcomes
Injury incidence
Time frame: September 2017 - December 2020
Technical tennis skills performance
Time frame: September 2017 - December 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared or will not be available to other researchers
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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.
Peter Clarys, PhD study director
Vrije Universiteit Brussel
Eva D'Hondt, PhD study director
Vrije Universiteit Brussel
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 Development; Unilateral, run by Laurent Chapelle at 1 site in Belgium.
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: status not confirmed, as of the sponsor's last update on 25 Apr 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurent Chapelle, Msc (+32477472756, laurent.chapelle@vub.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometry (time frame: September 2017 - December 2020). The study lists 4 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 25 Apr 2017.