NCT04221698

Brief Summary

In running 70% of the lower limb, injuries are produced in the running segment. The vast majority of sports-related musculoskeletal injuries in young athletes are caused by overuse. Previous research has shown a clear association between running-related injuries and kinematic patterns, showing the existence of a causal relationship between biomechanical alterations and injures. According to the evidence, that real-time visual and auditory feedback based on gait retraining should be considered to treat injured runners or prevent injuries. However, no previous studies have been carried out on whether gait retraining decreases running-related injuries incidence in young triathletes. The investigators propose a study to determine the effect of gait retraining on the decrease in the number of running-related injuries and improve the running efficiency in young triathletes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

December 19, 2019

Last Update Submit

January 7, 2020

Conditions

Keywords

Gait AnalysisTriathlonRunningGait Retraining

Outcome Measures

Primary Outcomes (1)

  • Surface Electromyography

    Mean activation amplitude of gluteus medius.

    Baseline - 7 months

Secondary Outcomes (2)

  • 3D Kinematic Analysis

    Baseline - 7 months

  • Maximal Oxygen Consumption (VO2max)

    Baseline - 7 months

Other Outcomes (1)

  • Self-report Questionnaire about Running-related injuries

    Baseline - 7 months

Study Arms (1)

Gait Retraining Group

EXPERIMENTAL

Athletes from the Triathlon Plan in High Performance of the Valencian Community in Spain performing individual gait retraining sessions

Other: Gait retraining

Interventions

5 gait retraining sessions of continuous feedback in real time during running sessions; using videotape feedback, a digital metronome to increase step rate, and verbal feedback to reduce the tendency to heel strike upon ground contact. Verbal feedback is offered during the 25- to 30-minute running sessions following a series of drills aimed at improving running mechanics.

Gait Retraining Group

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Triathletes included in the Triathlon Plan in High Performance of the Valencian Community in Spain.
  • Reported running a minimum of 2 days per week for the last 3 months with no reported injury.
  • Worst pain rated a minimum of 3 out 10 on a numerical rating scale (NRS) for pain (0=no pain, 10=worst possible pain)

You may not qualify if:

  • Previous musculoskeletal surgery.
  • Neurological impairment
  • Structural deformity in the knee.
  • Pain suffered by trauma or sports activity, having stopped running or receiving additional treatment outside the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan J. Amer-Cuenca

Alfara del Patriarca, Valencia, 46113, Spain

Location

Related Publications (2)

  • Bramah C, Preece SJ, Gill N, Herrington L. A 10% Increase in Step Rate Improves Running Kinematics and Clinical Outcomes in Runners With Patellofemoral Pain at 4 Weeks and 3 Months. Am J Sports Med. 2019 Dec;47(14):3406-3413. doi: 10.1177/0363546519879693. Epub 2019 Oct 28.

  • Bramah C, Preece SJ, Gill N, Herrington L. Is There a Pathological Gait Associated With Common Soft Tissue Running Injuries? Am J Sports Med. 2018 Oct;46(12):3023-3031. doi: 10.1177/0363546518793657. Epub 2018 Sep 7.

Study Officials

  • Javier Martínez-Gramage, PhD

    CEU Cardenal Herrera University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice Dean

Study Record Dates

First Submitted

December 19, 2019

First Posted

January 9, 2020

Study Start

October 1, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

January 9, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations