Sport-related ConcussionNCT06774976
Effect of Neck Training on Outcomes Related to Sport-Related Concussion
A study testing 8-week Evidence-Based Neck Resistance Training Program in people with Sport-related Concussion, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sport-related Concussion
- What is being tested?
- 8-week Evidence-Based Neck Resistance Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 8 Jan 2026to 7 May 2026
- Phase
- Interventional
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Acceptability of an Evidence-Based Neck Resistance Training Program on Head Acceleration and Isometric Neck Strength in Female Soccer Players: A Pilot Quasi-Experimental Trial
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.
Read the detailed description
This study aims to evaluate the efficacy and acceptability of a novel evidence-based neck resistance training program for female soccer players. The primary objective is to assess the program's impact on neck strength and head accelerations during impact, with the broader goal of informing strategies to reduce the risk of sport-related concussions in soccer. A pilot quasi-experimental design will be employed to test the intervention and collect preliminary data for future large-scale trials.
Two senior-level female soccer teams will be invited to participate in the study. One team will be allocated to the intervention group, while the other will serve as the control group. The intervention group will undertake an eight-week neck resistance training program designed according to current resistance training prescription guidelines. The program consists of both static and dynamic exercises implemented with a head harness and resistance tubing to allow variable resistance loads. To ensure flexibility and adherence, the program is designed to be conducted either during the team's regular on-field soccer training or off-field gym sessions. Participants will complete the exercises two to three times per week. The control group will continue their usual training practices without incorporating any neck-specific resistance training during the study period.
Before the intervention, participants from both teams will undergo comprehensive baseline testing at Lund University's Movement and Reality Lab (MoRe-Lab). The testing will include three main components: isometric neck strength testing, head acceleration testing, and muscle activation analysis. Neck strength will be assessed in four cervical directions-flexion, extension, lateral flexion, and rotation-using a handheld dynamometer. Athletes will be seated in a high-backed chair and secured with straps to isolate head and neck movement. A snugly fitted head harness will be connected to the dynamometer, and participants will be instructed to exert maximal force during three-second isometric contractions in each direction. Each athlete will perform three repetitions, and the highest force value recorded in newtons will be used for data analysis.
Head acceleration will be assessed using a custom-built device designed to measure safe, controlled head movements. Athletes will be seated in the device and strapped securely to ensure only head and neck movement is permitted. A head harness connected to a drop mechanism will deliver a one-kilogram weight drop from a height proportional to the athlete's stature. This will produce safe, measurable linear and rotational head accelerations, with head movement captured by the Qualisys motion capture system. Data from this system will be used to calculate both linear and rotational accelerations in all four cervical directions.
To evaluate muscle activation patterns during head acceleration testing, surface electromyography (EMG) sensors will be placed on the sternocleidomastoid muscles and the trapezius (pars descendens). These exploratory outcomes will provide additional insights into the neuromuscular responses elicited by the intervention.
Following the baseline assessments, teams will proceed to the intervention phase. After the eight-week intervention, participants will return for follow-up testing, which will replicate the baseline assessments. At the conclusion of the study, all players and coaches will complete a questionnaire designed to evaluate the acceptability of the exercise program. This questionnaire will include both Likert-scale items and open-ended questions, allowing participants to provide detailed feedback and suggest potential improvements to the program.
Data analysis will focus on comparing changes in key outcomes within and between the intervention and control groups. The primary outcomes-changes in isometric neck strength and head accelerations-will be analyzed using repeated measures analysis of variance (ANOVA). Secondary outcomes, including the acceptability data, will be analyzed descriptively for Likert-scale responses, while qualitative feedback from open-ended questions will undergo thematic analysis. Exploratory outcomes, such as muscle activation data, will be evaluated descriptively to assess activation patterns during head accelerations.
To ensure adequate statistical power, an a priori sample size calculation using G*Power (v. 3.1.9.7, Düsseldorf, Germany) determined that a minimum of 34 participants would be required for repeated measures ANOVA (effect size f > 0.25, power 0.80, α = 0.05). Adjusting for cluster randomization using a variance inflation factor with a moderate intracluster correlation coefficient (ρ = 0.05) and accounting for a 25% dropout rate, the target sample size increased to 96 participants. For this pilot study, approximately half of the required sample size-around 50 participants-will be enrolled across the two soccer teams. This approach ensures the safety and feasibility of the intervention, provides preliminary effect sizes, and informs the design of a future full-scale trial.
The research team includes Branimir Ivanic, PT, MSc, Anna Cronström, PT, PhD, Nicholas Ryan, PhD, and Professor Eva Ageberg, PT, PhD, all affiliated with Lund University, Sweden. Professor Ageberg serves as the Principal Investigator for the study.
- Conditions
- Sport-related Concussion
- Being tested
- 8-week Evidence-Based Neck Resistance Training Program
- Keywords
- Sport-related concussion, Neck muscles, Primary prevention, Resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-week Evidence-Based Neck Resistance Training ProgramOther
See arm/group description.
| Study group | Role | What they receive |
|---|---|---|
| Neck Resistance Training | Experimental | 8-week Evidence-Based Neck Resistance Training Program Receives: Other: 8-week Evidence-Based Neck Resistance Training Program |
| Training as Usual | No intervention | Usual Training Regiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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, which has been developed in accordance with the Theoretical Framework of Acceptability, consists of seven statements that athletes will rate on a 5-point Likert scale (1=strongly disagree; 5=strongly agree), as well as two open-ended questions.
Measured: The questionnaire will be distributed to athletes and trainers at the end of the 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start8 Jan 2026
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport-related ConcussionStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Ageberg, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774976
- Sponsor's protocol ID
- MLP1033
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD for primary and secondary outcomes will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Acceptability of an Evidence-Based Neck Resistance Training Program on Head Acceleration and Isometric Neck Strength in Female Soccer Players: A Pilot Quasi-Experimental Trial
- ClinicalTrials.gov ID
- NCT06774976
- Acronym / sponsor ID
- MLP1033
- Conditions
- Sport-related Concussion
- Keywords
- Sport-related concussion, Neck muscles, Primary prevention, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 14 Jan 2025 (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.
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.
Detailed description
This study aims to evaluate the efficacy and acceptability of a novel evidence-based neck resistance training program for female soccer players. The primary objective is to assess the program's impact on neck strength and head accelerations during impact, with the broader goal of informing strategies to reduce the risk of sport-related concussions in soccer. A pilot quasi-experimental design will be employed to test the intervention and collect preliminary data for future large-scale trials.
Two senior-level female soccer teams will be invited to participate in the study. One team will be allocated to the intervention group, while the other will serve as the control group. The intervention group will undertake an eight-week neck resistance training program designed according to current resistance training prescription guidelines. The program consists of both static and dynamic exercises implemented with a head harness and resistance tubing to allow variable resistance loads. To ensure flexibility and adherence, the program is designed to be conducted either during the team's regular on-field soccer training or off-field gym sessions. Participants will complete the exercises two to three times per week. The control group will continue their usual training practices without incorporating any neck-specific resistance training during the study period.
Before the intervention, participants from both teams will undergo comprehensive baseline testing at Lund University's Movement and Reality Lab (MoRe-Lab). The testing will include three main components: isometric neck strength testing, head acceleration testing, and muscle activation analysis. Neck strength will be assessed in four cervical directions-flexion, extension, lateral flexion, and rotation-using a handheld dynamometer. Athletes will be seated in a high-backed chair and secured with straps to isolate head and neck movement. A snugly fitted head harness will be connected to the dynamometer, and participants will be instructed to exert maximal force during three-second isometric contractions in each direction. Each athlete will perform three repetitions, and the highest force value recorded in newtons will be used for data analysis.
Head acceleration will be assessed using a custom-built device designed to measure safe, controlled head movements. Athletes will be seated in the device and strapped securely to ensure only head and neck movement is permitted. A head harness connected to a drop mechanism will deliver a one-kilogram weight drop from a height proportional to the athlete's stature. This will produce safe, measurable linear and rotational head accelerations, with head movement captured by the Qualisys motion capture system. Data from this system will be used to calculate both linear and rotational accelerations in all four cervical directions.
To evaluate muscle activation patterns during head acceleration testing, surface electromyography (EMG) sensors will be placed on the sternocleidomastoid muscles and the trapezius (pars descendens). These exploratory outcomes will provide additional insights into the neuromuscular responses elicited by the intervention.
Following the baseline assessments, teams will proceed to the intervention phase. After the eight-week intervention, participants will return for follow-up testing, which will replicate the baseline assessments. At the conclusion of the study, all players and coaches will complete a questionnaire designed to evaluate the acceptability of the exercise program. This questionnaire will include both Likert-scale items and open-ended questions, allowing participants to provide detailed feedback and suggest potential improvements to the program.
Data analysis will focus on comparing changes in key outcomes within and between the intervention and control groups. The primary outcomes-changes in isometric neck strength and head accelerations-will be analyzed using repeated measures analysis of variance (ANOVA). Secondary outcomes, including the acceptability data, will be analyzed descriptively for Likert-scale responses, while qualitative feedback from open-ended questions will undergo thematic analysis. Exploratory outcomes, such as muscle activation data, will be evaluated descriptively to assess activation patterns during head accelerations.
To ensure adequate statistical power, an a priori sample size calculation using G*Power (v. 3.1.9.7, Düsseldorf, Germany) determined that a minimum of 34 participants would be required for repeated measures ANOVA (effect size f > 0.25, power 0.80, α = 0.05). Adjusting for cluster randomization using a variance inflation factor with a moderate intracluster correlation coefficient (ρ = 0.05) and accounting for a 25% dropout rate, the target sample size increased to 96 participants. For this pilot study, approximately half of the required sample size-around 50 participants-will be enrolled across the two soccer teams. This approach ensures the safety and feasibility of the intervention, provides preliminary effect sizes, and informs the design of a future full-scale trial.
The research team includes Branimir Ivanic, PT, MSc, Anna Cronström, PT, PhD, Nicholas Ryan, PhD, and Professor Eva Ageberg, PT, PhD, all affiliated with Lund University, Sweden. Professor Ageberg serves as the Principal Investigator for the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck Resistance Training | Experimental | Other: 8-week Evidence-Based Neck Resistance Training Program8-week Evidence-Based Neck Resistance Training Program |
| Training as Usual | No intervention | –Usual Training Regiment |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8-week Evidence-Based Neck Resistance Training ProgramSee arm/group description. | Other | Neck Resistance Training |
Primary outcome
Linear head acceleration
Time frame: Measurements will be taken at baseline and after the 8-week intervention program.
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).
Rotational head acceleration
Time frame: Measurements will be taken at baseline and after the 8-week intervention program.
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).
Isometric neck strength
Time frame: Measurements will be taken at baseline and after the 8-week intervention program.
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).
1 secondary outcome
Acceptability of an evidence-based neck resistance training program
Time frame: The questionnaire will be distributed to athletes and trainers at the end of the 8-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD for primary and secondary outcomes will be made available upon reasonable request.
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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.
Eva Ageberg, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-week Evidence-Based Neck Resistance Training Program in people with Sport-related Concussion, run by Lund University at 1 site in Sweden.
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 7 inclusion and 0 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: finished, as of the sponsor's last update on 5 Oct 2026. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear head acceleration (time frame: Measurements will be taken at baseline and after the 8-week intervention program.). The study lists 3 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 5 Oct 2026.