Gait RetrainingNCT04221698
Do Young Triathletes Have a Greater Predisposition to Suffer Running Injuries
A study testing Gait retraining in people with Gait Retraining and Kinematics, run by J.J. Amer-Cuenca at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Retraining, Kinematics
- What is being tested?
- Gait retraining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Gait Retraining, Kinematics
- Being tested
- Gait retraining
- Keywords
- Gait Analysis, Triathlon, Running, Gait Retraining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait retrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Gait Retraining Group | Experimental | Athletes from the Triathlon Plan in High Performance of the Valencian Community in Spain performing individual gait retraining sessions Receives: Other: Gait retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface Electromyography
Mean activation amplitude of gluteus medius.
Measured: Baseline - 7 months
Secondary outcomes (2)
3D Kinematic Analysis
Peak angle at midstance defined as of the maximum pelvis joint angle between initial contact and toe-off. The tool to assess this variable would be an Inertial measurement unit (IMU) located at sacral vertebra S1
Measured: Baseline - 7 months
Maximal Oxygen Consumption (VO2max)
Oxygen Consumption during running
Measured: Baseline - 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Oct 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gait RetrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- J.J. Amer-Cuenca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, J.J. Amer-Cuenca, Cardenal Herrera University
- Investigators
- Javier Martínez-Gramage, PhD, Principal investigator, CEU Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221698
- Sponsor's protocol ID
- CEI18/137
- Status last verified
- Jan 2020
- First submitted
- 19 Dec 2019
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31657964Bramah 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.
PubMed 30193080
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Young Triathletes Have a Greater Predisposition to Suffer Running Injuries
- ClinicalTrials.gov ID
- NCT04221698
- Acronym / sponsor ID
- CEI18/137
- Conditions
- Gait Retraining, Kinematics
- Keywords
- Gait Analysis, Triathlon, Running, Gait Retraining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- J.J. Amer-CuencaUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 9 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait Retraining Group | Experimental | Other: Gait retrainingAthletes from the Triathlon Plan in High Performance of the Valencian Community in Spain performing individual gait retraining sessions |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait retraining5 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. | Other | Gait Retraining Group |
Primary outcome
Surface Electromyography
Time frame: Baseline - 7 months
Mean activation amplitude of gluteus medius.
2 secondary outcomes
3D Kinematic Analysis
Time frame: Baseline - 7 months
Maximal Oxygen Consumption (VO2max)
Time frame: Baseline - 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Results publication: PubMed 31657964Bramah 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.
- Results publication: PubMed 30193080Bramah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Martínez-Gramage, PhD principal investigator
CEU Cardenal Herrera University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait retraining in people with Gait Retraining and Kinematics, run by J.J. Amer-Cuenca at 1 site in Spain.
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 3 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: finished, as of the sponsor's last update on 9 Jan 2020. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surface Electromyography (time frame: Baseline - 7 months). 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 NCT04221698, which also lists 2 linked publications.
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 9 Jan 2020.