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Sport InjuryNCT06551454

Smart Textile Solutions as Biofeedback Method for Injury Prevention for Latvian Football Youth League Players

A study testing Smart Textile Solution Biofeedback Method in people with Sport Injury, run by Riga Stradins University at 1 site in Latvia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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%. Read more about this study

Who is it for?
Ages 14 to 18 years
Conditions the study is for
Sport Injury
What is being tested?
Smart Textile Solution Biofeedback Method
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteLatvia
Study dates
25 Sep 2025to 1 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 14 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guna Semjonova, Ph.D. contact

+37126035528

guna.semjonova@rsu.lv

Anna Davidovica, M.H.Sc. contact

anna.davidovica@rsu.lv

Latvia1 site, 1 recruiting

  • Latvian Football Federation

    Riga, LV-1013

    Sergejs Davidovics, M.Sc., sergejs.davidovics@gmail.com

    Anna Davidovica, M.Sc.

    Recruiting

Other trials in Latvia

About this study

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.

Conditions
Sport Injury
Being tested
Smart Textile Solution Biofeedback Method
Keywords
smart textile sock system, youth athletes, football, soccer, biofeedback, injurie prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smart Textile Solution Biofeedback MethodDevice

    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.

Study groups in NCT06551454
Study groupRoleWhat they receive
Football Youth League Players groupActive comparatorIntervention 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.
Receives: Device: Smart Textile Solution Biofeedback Method
Smart Textile Biofeedback Football Youth League Players groupExperimentalUsing 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.
Receives: Device: Smart Textile Solution Biofeedback Method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Foot plantar pressure changes during functional tasks (FIFA 11+; Part 2)

    Data from the biofeedback method provided by the biofeedback DAid® smart sock system

    Measured: 12 weeks

  2. Functional Movement

    Change of Functional Movement Screening (FMS™) Scores

    Measured: 2 times: pre and post 12 week intervention

Secondary outcomes (6)

  1. Age

    Age in years

    Measured: 1 time.

  2. Sex

    Answers: male, female

    Measured: 1 time

  3. Foot size

    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.

    Measured: 1 time

  4. positions on football field

    1 - Goalkeeper · 2 - Right Back · 3 - Left Back · 4 - Center Back · 5 - Center Back · 6 - Defensive Midfield · 7 - Right Wing/Forward · 8 - Central Midfield.

    Measured: 1 time

  5. User experience

    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.

    Measured: Once - after 12 weeks of intervention

  6. Frequency of non-contact injuries (predicted number of injuries)

    A one-year follow-up of records of the Frequency of non-contact injuries (predicted number of injuries)

    Measured: 1 year after 12-weeks intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2024
  2. Study start25 Sep 2025
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Oct 2026 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06551454
Sponsor's protocol ID
lzp-2023/1-0027
Status last verified
Sep 2025
First submitted
24 Jul 2024
Last updated
1 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: https://zenodo.org/records/12804841

Questions about this trial

What is this clinical trial studying?

A study testing Smart Textile Solution Biofeedback Method in people with Sport Injury, run by Riga Stradins University at 1 site in Latvia.

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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. 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 Latvia. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guna Semjonova, Ph.D. (+37126035528, guna.semjonova@rsu.lv), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Foot plantar pressure changes during functional tasks (FIFA 11+; Part 2) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06551454.

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 1 Oct 2025.

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