NCT06217835

Brief Summary

Gluteus Medius (GM) has also been implicated in the development of Low Back Pain (LBP). GM is one of the main pelvic, where he actively participates in control of motion in the frontal and transverse plane, and hip , improving stability to the lumbopelvic-hip complex. The aim of present study was to investigate whether modifying lower limb length with a different foot insoles of 0.5, 1 and 1.5 cm in a normal population has an effect on ES and GM activity and as a consequence in LBP. As a secondary objective, in turn, to evaluate whether ES and GM activity has an effect on jumping ability as assessed through CMJ.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

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

March 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

December 4, 2023

Last Update Submit

April 29, 2024

Conditions

Keywords

Low Back PainelectromyographyLeg Length Inequalitylower limb length

Outcome Measures

Primary Outcomes (5)

  • Height CMJ

    CMJ jump flight height

    1 week

  • Height DJ LEFT

    Flying height in drop jump left leg

    1 week

  • Height DJ RIGHT

    Flying height in drop jump right leg

    1 week

  • Gluteus medius (mv)

    Gluteus medius activation (mv)

    1 week

  • Erector Spinae (mv)

    Erector Spinae activation (mv)

    1 week

Study Arms (3)

0,5 cm jig

EXPERIMENTAL

A template with the dimensions indicated is introduced to the user and he/she walks for 1 minute.

Other: To evaluate the response of an orthopedic insoleOther: evaluate activation of musculature

1 cm jig

EXPERIMENTAL

A template with the dimensions indicated is introduced to the user and he/she walks for 1 minute.

Other: To evaluate the response of an orthopedic insoleOther: evaluate activation of musculature

1,5 cm jig

EXPERIMENTAL

A template with the dimensions indicated is introduced to the user and he/she walks for 1 minute.

Other: To evaluate the response of an orthopedic insoleOther: evaluate activation of musculature

Interventions

To evaluate the response of an orthopedic insole of different heights on gait.

0,5 cm jig1 cm jig1,5 cm jig

To evaluate the response caused by an orthopedic insole of different heights on the indicated musculature.

0,5 cm jig1 cm jig1,5 cm jig

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • The volunteers had no problems in range of motion of joints of the lower limbs
  • pelvic obliquity due to a functional leg length discrepancy.
  • obesity with body mass index (BMI) 35 \> kg/m²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan Hernández Lougedo

Villanueva de la Cañada, Madrid, Spain

Location

MeSH Terms

Conditions

Muscular Disorders, AtrophicLow Back PainLeg Length Inequality

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBone Diseases, DevelopmentalBone DiseasesPathological Conditions, Anatomical

Study Officials

  • Eduardo Cimadevilla, PT

    Camilo Jose Cela University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

January 23, 2024

Study Start

March 20, 2023

Primary Completion

June 3, 2023

Study Completion

September 8, 2023

Last Updated

April 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations