NCT06774976

Brief Summary

Sport-related concussion (SRC) is a significant concern in soccer. This pilot quasi-experimental trial aims to investigate the efficacy and acceptability of an evidence-based neck resistance exercise program in female soccer athletes for SRC prevention. The 8-week intervention includes dynamic and static neck exercises designed to reduce linear and rotational head accelerations, improve neck muscle strength, and minimise SRC risk. The study will evaluate program outcomes through laboratory testing, questionnaires, and user feedback. Findings from this pilot study will inform the design and implementation of a full-scale study, aiming to advance preventive strategies in SRC and address the underrepresentation of female athletes in research.

Trial Health

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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Sep 2025Dec 2026

First Submitted

Initial submission to the registry

January 7, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

January 7, 2025

Last Update Submit

March 14, 2025

Conditions

Keywords

Sport-related concussionNeck musclesPrimary preventionResistance training

Outcome Measures

Primary Outcomes (3)

  • Linear head acceleration

    Linear head accelerations will be assessed during impulsive loads applied to the head in four cervical directions: flexion, extension, lateral flexion, and rotation. The impulsive load will be induced using a custom-made device, and linear accelerations will be measured with a Qualisys motion capture system, reported in units of gravitational force (g-force).

    Measurements will be taken at baseline and after the 8-week intervention program.

  • Rotational head acceleration

    Rotational head accelerations will be assessed during impulsive loads applied to the head in four cervical directions: flexion, extension, lateral flexion, and rotation. The impulsive load will be induced using a custom-made device, and rotational accelerations will be measured with a Qualisys motion capture system, reported in radians per second squared (rad/s²).

    Measurements will be taken at baseline and after the 8-week intervention program.

  • Isometric neck strength

    Isometric neck strength measured in all four cervical directions (flexion, extension, lateral flexion, and rotation) using a handheld dynamometer and will be reported in Newtons (N).

    Measurements will be taken at baseline and after the 8-week intervention program.

Secondary Outcomes (1)

  • Acceptability of an evidence-based neck resistance training program

    The questionnaire will be distributed to athletes and trainers at the end of the 8-week

Other Outcomes (2)

  • Neck Muscle Activation Timing

    Measurements will be taken at baseline and after the 8-week intervention program.

  • Neck Muscle Activation Amplitude

    Measurements will be taken at baseline and after the 8-week intervention program.

Study Arms (2)

Neck Resistance Training

EXPERIMENTAL

8-week Evidence-Based Neck Resistance Training Program

Other: 8-week Evidence-Based Neck Resistance Training Program

Training as Usual

NO INTERVENTION

Usual Training Regiment

Interventions

See arm/group description.

Neck Resistance Training

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Teams that are located in Skåne county
  • Teams that are trained by professional trainers who are financially compensated for their work
  • Teams that are not engaged in any targeted neck-strengthening exercises during the trial period beyond those prescribed within the trial
  • Players that are 16 years of age or older
  • Players that regularly attend all senior-level team activities, including training and match sessions
  • Players that free of any injuries to their upper or lower limbs, torso, neck, or head at the time of enrolment
  • Players with no history of undiagnosed neck pain within the previous three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MoRe Lab

Lund, 22100, Sweden

Location

Study Officials

  • Eva Ageberg, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 14, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

De-identified IPD for primary and secondary outcomes will be made available upon reasonable request.

Locations