NCT06551454

Brief 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%. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Sep 2025Oct 2026

First Submitted

Initial submission to the registry

July 24, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

July 24, 2024

Last Update Submit

September 25, 2025

Conditions

Keywords

smart textile sock systemyouth athletesfootballsoccerbiofeedbackinjurie prevention

Outcome Measures

Primary Outcomes (2)

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

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

    12 weeks

  • Functional Movement

    Change of Functional Movement Screening (FMS™) Scores

    2 times: pre and post 12 week intervention

Secondary Outcomes (6)

  • Age

    1 time.

  • Sex

    1 time

  • Foot size

    1 time

  • positions on football field

    1 time

  • User experience

    Once - after 12 weeks of intervention

  • +1 more secondary outcomes

Study Arms (2)

Football Youth League Players group

ACTIVE COMPARATOR

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

Smart Textile Biofeedback Football Youth League Players group

EXPERIMENTAL

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

Interventions

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.

Football Youth League Players groupSmart Textile Biofeedback Football Youth League Players group

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Latvian Football Federation

Riga, LV-1013, Latvia

RECRUITING

Related Links

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guna Semjonova, Ph.D.

CONTACT

Anna Davidovica, M.H.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Principal Investigator, Scientific Project Coordinator, Department of Rehabilitation at Riga Stradins University

Study Record Dates

First Submitted

July 24, 2024

First Posted

August 13, 2024

Study Start

September 25, 2025

Primary Completion

January 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

https://zenodo.org/records/12804841

Locations