NCT05955599

Brief Summary

The anterior Cruciate Ligament (ACL) injuries rates in female handball are high, particularly among adolescents. Therefore, the primary purpose of this randomized control trial is to explore the effects of an 8-week ACL injury prevention program on muscle activation of the medial hamstring muscles during sidecutting in female handball players. Secondary aims are to evaluate if training effects are age-related (pre-adolescent: 11-13 year old vs. adults: ≥18 years old). The age-related comparisons Include:

  1. 1.Medial hamstring muscles activation during sidecutting;
  2. 2.Well-known biomechanical ACL injury-risk factors during high risk movements, such as cutting and landing tasks;
  3. 3.Cortical and muscular activity and functional connectivity patterns during controlled knee movements;
  4. 4.Visuomotor skill learning during a simple task involving the hamstring muscles.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

January 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

April 21, 2023

Last Update Submit

July 13, 2023

Conditions

Keywords

ACL InjuriesAge-relatedNeuromuscularMotor-Learning

Outcome Measures

Primary Outcomes (1)

  • Neuromuscular adaptations during sidecutting

    Semitendinosus muscle pre-activity (sEMG) duirng handball specific sidecutting. Outcome measure is expressed in %MVC.during sidecutting.

    Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.

Secondary Outcomes (7)

  • Changes in isometric strength

    Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.

  • Changes in 3D hip and knee joint angles

    Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.

  • Changes in 3D hip and knee joint moments

    Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.

  • Changes in hamstring and quadriceps pre-activation

    Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.

  • Visuomotor Skill Learning

    Change from Baseline to Baseline +1 Day, Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.

  • +2 more secondary outcomes

Other Outcomes (2)

  • Injury monitoring

    Weekly for 16 weeks (from the start of the intervention to the end of the 8-week retention period)

  • Training and match exposure

    Weekly for 16 weeks (from the start of the intervention to the end of the 8-week retention period)

Study Arms (4)

Pre-adolescent Intervention

EXPERIMENTAL

11-13 year old female handball players complete a supervised ACL injury prevention program twice a week (2 x 15 minutes) for a duration of 8 weeks. The ACL injury prevention training consists of three tracks focusing on 1) hamstring and hip external rotation strength; 2) medial hamstring activation; 3) single leg landing technique training with a special focus on knee control. The training is integrated in the players/team's normal handball practice.

Other: ACL Injury Prevention Training

Pre-adolescent Control

OTHER

11-13 year old female handball players complete a supervised shoulder injury prevention program twice a week (2 x 15 minutes) for a duration of 8 weeks. The shoulder injury prevention training consists of three tracks focusing on 1) external rotator cuff strength; 2) scapula stability; 3) core strength and trunk rotation. The training is integrated in the players/team's normal handball practice.

Other: Control - Shoulder Injury Prevention Training

Adult Intervention

EXPERIMENTAL

Adult (≥18 year old) female handball players complete a supervised ACL injury prevention program twice a week (2 x 15 minutes) for a duration of 8 weeks. The ACL injury prevention training consists of three tracks focusing on 1) hamstring and hip external rotation strength; 2) medial hamstring activation; 3) single leg landing technique training with a special focus on knee control. The training is integrated in the players/team's normal handball practice.

Other: ACL Injury Prevention Training

Adult Control

OTHER

Adult (≥18 year old) female handball players completed a supervised shoulder injury prevention program twice a week (2 x 15 minutes) for a duration of 8 weeks. The shoulder injury prevention training consists of three tracks focusing on 1) external rotator cuff strength; 2) scapula stability; 3) core strength and trunk rotation. The training is integrated in the players/team's normal handball practice.

Other: Control - Shoulder Injury Prevention Training

Interventions

Supervised ACL injury prevention training twice a week (2 x 15 minutes) over an 8-week period.

Adult InterventionPre-adolescent Intervention

Supervised shoulder injury prevention training twice a week (2 x 15 minutes) over an 8-week period.

Adult ControlPre-adolescent Control

Eligibility Criteria

Age11 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female handball players playing in youth teams from the age group under 13 (11-13 years old) and adult (≥18 - 40 years old) females playing for elite u19 or senior teams in Denmark
  • Have minimum 1 year of experience from playing handball
  • Mental and physical skills to complete the electrophysiological and biomechanical tests

You may not qualify if:

  • Girls/women outside the age groups listed above
  • Prior surgeries to the lower limbs (e.g. ACL-reconstructions, meniscus lesions)
  • Current intake of medications that include antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
  • Neurological and/or psychiatric diagnoses
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Midwifery, Physiotherapy, Occupational Therapy and Psychomotor Therapy, Faculty of Health, University College Copenhagen

Copenhagen, 2200, Denmark

Location

Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark

Copenhagen, 2200, Denmark

Location

Human Movement Analysis Laboratory, Department of Orthopaedic Surgery, Copenhagen University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • Nedergaard NJ, Bencke J, Egholm J, Nielsen AL, Karabanov AN, Lundbye-Jensen J, Zebis MK. No Alterations in ACL Injury Risk Factors in Preadolescent Elite Female Handball Players Following an Eight-Week Targeted Training Intervention: A Randomised Controlled Trial. Transl Sports Med. 2026 Jan 2;2026:2570210. doi: 10.1155/tsm2/2570210. eCollection 2026.

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sub-Investigator

Study Record Dates

First Submitted

April 21, 2023

First Posted

July 21, 2023

Study Start

January 1, 2022

Primary Completion

February 28, 2023

Study Completion

December 31, 2025

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations