NCT06490354

Brief Summary

Lightback is a patented device that allows instrumental stretching of the gluteal muscles. Football players overload this musculature and this type of device is effective and the cost/benefit ratio is high. The intention is to carry out a randomised clinical trial to carry out a study on athletes to see the differences between a group of football players with their normal training and a group of football players with their normal training and the application of lightback beforehand. The variables studied will be sprint speed in 20 and 40m, vertical jump height, hamstring muscle injuries throughout the season, triceps sural injuries throughout the season, internal and external hip ROM, dorsal flexion ankle ROM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

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

First Submitted

Initial submission to the registry

June 29, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

June 29, 2024

Last Update Submit

March 24, 2025

Conditions

Keywords

hipgluteal regionsrange of motion, articularfootballs

Outcome Measures

Primary Outcomes (1)

  • Range of motion

    Measurement of hip joint range and ankle dorsiflexion measured with goniometer

    5 weeks

Secondary Outcomes (2)

  • Sprint

    5 weeks

  • Vertical jump height

    5 weeks

Study Arms (2)

Lightback group

EXPERIMENTAL

Use of the lightback device to relax the gluteal musculature.

Device: Lightback group

Conventional group

ACTIVE COMPARATOR

Conventional treatment to relax the gluteal musculature and prevent hamstring injuries.

Other: Conventional treatment

Interventions

Use of the patented Lightback device to relax the gluteal musculature and prevent hamstring injuries.

Lightback group

Conventional treatment to relax the gluteal musculature and prevent hamstring injuries.

Conventional group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Professional football players
  • Age range 18 to 45 years
  • Able to perform physical exertion without discomfort.

You may not qualify if:

  • Football players recently injured or in an active recovery phase.
  • Heterometrics
  • Non-collaborators
  • Alteration of sensitivity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica de Ávila

Ávila, 05005, Spain

Location

Related Publications (7)

  • Fernandes CA, Norte GE, Schwab SM, Gokeler A, Murray A, Bazett-Jones DM, Sherman DA. Interpersonal Coordination between Female Soccer Players: Leader-Follower Roles within a Collision-Avoidance Task. Int J Sports Phys Ther. 2024 May 1;19(5):548-560. doi: 10.26603/001c.116156. eCollection 2024.

    PMID: 38707861BACKGROUND
  • Junge A, Dvorak J. Soccer injuries: a review on incidence and prevention. Sports Med. 2004;34(13):929-38. doi: 10.2165/00007256-200434130-00004.

  • Pirri C, Pirri N, Guidolin D, Macchi V, Porzionato A, De Caro R, Stecco C. Ultrasound Imaging in Football Players with Previous Multiple Ankle Sprains: Keeping a Close Eye on Superior Ankle Retinaculum. Bioengineering (Basel). 2024 Apr 25;11(5):419. doi: 10.3390/bioengineering11050419.

  • Al Attar WSA, Soomro N, Sinclair PJ, Pappas E, Sanders RH. Effect of Injury Prevention Programs that Include the Nordic Hamstring Exercise on Hamstring Injury Rates in Soccer Players: A Systematic Review and Meta-Analysis. Sports Med. 2017 May;47(5):907-916. doi: 10.1007/s40279-016-0638-2.

  • Biz C, Nicoletti P, Baldin G, Bragazzi NL, Crimi A, Ruggieri P. Hamstring Strain Injury (HSI) Prevention in Professional and Semi-Professional Football Teams: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Aug 4;18(16):8272. doi: 10.3390/ijerph18168272.

  • Petersen J, Thorborg K, Nielsen MB, Budtz-Jorgensen E, Holmich P. Preventive effect of eccentric training on acute hamstring injuries in men's soccer: a cluster-randomized controlled trial. Am J Sports Med. 2011 Nov;39(11):2296-303. doi: 10.1177/0363546511419277. Epub 2011 Aug 8.

  • Lovell R, Knox M, Weston M, Siegler JC, Brennan S, Marshall PWM. Hamstring injury prevention in soccer: Before or after training? Scand J Med Sci Sports. 2018 Feb;28(2):658-666. doi: 10.1111/sms.12925. Epub 2017 Jun 28.

MeSH Terms

Conditions

Hip Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Single blinding.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 29, 2024

First Posted

July 8, 2024

Study Start

July 1, 2024

Primary Completion

November 30, 2024

Study Completion

March 24, 2025

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations