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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Latvia
      • Riga, Latvia, LV-1013
        • Recruiting
        • Latvian Football Federation
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. youth football league players;
  2. agree to participate in the study;
  3. age from 14 to 18 years;
  4. understands and speaks Latvian.

Exclusion Criteria:

  1. operative treatment in the lower limb within the last 9 months;
  2. injuries or pain in the lower limb during the last 6 months;
  3. disorders of the vestibular apparatus
  4. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Smart Textile Solution Biofeedback Method
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.
Device: Smart Textile Solution Biofeedback Method
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riga Stradins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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