Effect of Neck Training on Outcomes Related to Sport-Related Concussion
NCT ID: NCT06774976
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-09-30
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Physiological Effects of Soccer Heading
NCT04810130
The Impact of Eye and Body Training on the Injury Rate of Concussions in Female Soccer Players
NCT06473883
Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners
NCT03080246
Neuromuscular Training in Female Youth Soccer
NCT06136299
Effects of Injury Prevention Exercises on Performance and Neuromuscular Function
NCT03251404
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Neck Resistance Training
8-week Evidence-Based Neck Resistance Training Program
8-week Evidence-Based Neck Resistance Training Program
See arm/group description.
Training as Usual
Usual Training Regiment
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
8-week Evidence-Based Neck Resistance Training Program
See arm/group description.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
16 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lund University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eva Ageberg, PhD
Role: PRINCIPAL_INVESTIGATOR
Lund University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MoRe Lab
Lund, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MLP1033
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.