- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06551454
Smart Textile Solutions as Biofeedback Method for Injury Prevention for Latvian Football Youth League Players
September 25, 2025 updated by: Guna Semjonova, Riga Stradins University
Lower limb injuries are the most common in youth football leagues, accounting for 72% to 93% of all injuries.
The leading prevention program in football today is the FIFA 11+ warm-up program, which reduces the risk of injury by 30%.
Evidence from several studies confirms the addition of feedback during training reduces the incidence of injury by 40% .
Recent studies have shown that the smart textile sock system is an objective, easy-to-use tool for real-time foot monitoring and is an interactive feedback tool for athletes.
However, there is a lack of information on the impact of the objective feedback provided by the Smart Textile Sensor Socks System on the outcome measures of football players prevention programs.
In the first phase of the project, a cross-sectional study involving youth league footballers will be conducted to identify the most effective feedback elements of the smart sock system.
In the second phase, a pilot study will be conducted to evaluate the effectiveness of prevention exercises using the feedback provided by smart textile sensor socks.
The results of the functional tests and the study outcomes will be selected as performance indicators to evaluate the smart textile sensor sock system.
Conclusions on the use of the smart textile sensor sock system as a feedback method for injury prevention in Latvian Youth Football League players will be drawn based on the results obtained from the project.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guna Semjonova, Ph.D.
- Phone Number: +37126035528
- Email: guna.semjonova@rsu.lv
Study Contact Backup
- Name: Anna Davidovica, M.H.Sc.
- Email: anna.davidovica@rsu.lv
Study Locations
-
-
-
Riga, Latvia, LV-1013
- Recruiting
- Latvian Football Federation
-
Contact:
- Sergejs Davidovics, M.Sc.
- Email: sergejs.davidovics@gmail.com
-
Principal Investigator:
- Anna Davidovica, M.Sc.
-
Principal Investigator:
- Guna Semjonova, Ph.D.
-
Principal Investigator:
- Linda Lancere, Dr.Sc.Ing.
-
Principal Investigator:
- Signe Tomsone, Dr.Med.
-
Sub-Investigator:
- Alise Jonate, B.Sc.
-
Principal Investigator:
- Aleksandrs Okss, Dr.Habil.Sc.Ing.
-
Principal Investigator:
- Aleksejs Katasevs, Dr.Sc.Ing.
-
Sub-Investigator:
- Lydia Kamynina, B.Sc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- youth football league players;
- agree to participate in the study;
- age from 14 to 18 years;
- understands and speaks Latvian.
Exclusion Criteria:
- operative treatment in the lower limb within the last 9 months;
- injuries or pain in the lower limb during the last 6 months;
- disorders of the vestibular apparatus
- presence of metallic implants in the sensor application areas.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Football Youth League Players group
Intervention for all participants: 12 weeks of prevention exercise program in football FIFA 11+ tasks of part 2: single leg stance and squats.
Followed by exercise monitoring instructions in the FIFA 11+ user manual.
|
The Smart Textile Solution Biofeedback Method for injury prevention in youth league football players integrates sensors within socks to monitor key biomechanical indicators such as center of pressure and plantar pressure of the foot in real-time.
By providing immediate feedback and alerts on potential injury risks, the system helps players adjust their techniques during training sessions and prevent injuries during training and games.
|
|
Experimental: Smart Textile Biofeedback Football Youth League Players group
Using the biofeedback method provided by the DAid® smart sock system as the monitoring method of positioning the lower limb for the study group during 12 weeks of prevention exercise program in football FIFA 11+ tasks of part 2: single leg stance and squats.
|
The Smart Textile Solution Biofeedback Method for injury prevention in youth league football players integrates sensors within socks to monitor key biomechanical indicators such as center of pressure and plantar pressure of the foot in real-time.
By providing immediate feedback and alerts on potential injury risks, the system helps players adjust their techniques during training sessions and prevent injuries during training and games.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Foot plantar pressure changes during functional tasks (FIFA 11+; Part 2)
Time Frame: 12 weeks
|
Data from the biofeedback method provided by the biofeedback DAid® smart sock system
|
12 weeks
|
|
Functional Movement
Time Frame: 2 times: pre and post 12 week intervention
|
Change of Functional Movement Screening (FMS™) Scores
|
2 times: pre and post 12 week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: 1 time.
|
Age in years
|
1 time.
|
|
Sex
Time Frame: 1 time
|
Answers: male, female
|
1 time
|
|
Foot size
Time Frame: 1 time
|
By using In the Continental European system, where the shoe size is the length of the last, expressed in Paris points or 2⁄3 cm (6.67 mm), for both sexes and for adults and children alike.
The Continental European system is used in Austria, Belgium, Denmark, France, Germany, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland and most other continental European countries such as Latvia.
The system is sometimes described as Stich size (from Pariser Stich, the German name for the Paris point), or Stichmaß size (from a German name of a micrometer for internal measurements).
Shoe/ Stichmaß size 32 - 48.
|
1 time
|
|
positions on football field
Time Frame: 1 time
|
1 - Goalkeeper · 2 - Right Back · 3 - Left Back · 4 - Center Back · 5 - Center Back · 6 - Defensive Midfield · 7 - Right Wing/Forward · 8 - Central Midfield.
|
1 time
|
|
User experience
Time Frame: Once - after 12 weeks of intervention
|
Evaluated by System Usability Scale scale, user motivation intrinsic scale.
The system usability scale (SUS) is a simple, ten-item attitude Likert scale giving a global view of subjective assessments of usability.
The usability of a system, as defined by the ISO standard ISO 9241 Part 11, can be measured by taking into account the context of use of the system-i.e., who is using the system, what they are using it for, and the environment in which they are using it.
Furthermore, measurements of usability have several different aspects: - effectiveness (can users successfully achieve their objectives); - efficiency (how much effort and resource is expended in achieving those objectives); - satisfaction (was the experience satisfactory).
The formula for computing the final SUS score requires converting the raw scores, by subtracting 1 from each raw score, then utilizing the equation.
|
Once - after 12 weeks of intervention
|
|
Frequency of non-contact injuries (predicted number of injuries)
Time Frame: 1 year after 12-weeks intervention
|
A one-year follow-up of records of the Frequency of non-contact injuries (predicted number of injuries)
|
1 year after 12-weeks intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Signe Tomsone, Dr.Med., Faculty of Health and Sports Sciences, Department of Rehabilitation, Riga Stradiņš University
- Principal Investigator: Linda Lancere, Dr.sc.ing., Vidzeme University of Applied Sciences
- Principal Investigator: Aleksejs Katasevs, Dr.phys, Riga Technical University
- Principal Investigator: Aleksandrs Okss, Dr.Habil.Sci-Eng., Riga Technical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 25, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
July 24, 2024
First Submitted That Met QC Criteria
August 12, 2024
First Posted (Actual)
August 13, 2024
Study Record Updates
Last Update Posted (Estimated)
October 1, 2025
Last Update Submitted That Met QC Criteria
September 25, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- lzp-2023/1-0027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
https://zenodo.org/records/12804841
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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