NCT06114654

Brief Summary

The goal of this observational study is to to evaluate and correlate muscle activation in the gluteal musculature and ankle stability in a healthy population. The main question it aims to answer is: Is there a significant positive correlation between gluteal muscle activation and ankle stability? Participants will complete questionnaires on the functionality of foot and ankle pathologies related to their daily life and sports activities, and perform specific physical tests to assess muscle strength, ankle stability, and activation of the lower extremity musculature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

October 29, 2023

Last Update Submit

November 2, 2023

Conditions

Ankle DiseaseMuscle Weakness

Keywords

biomechanicselectromyographyankle stabilitygluteal musculature

Outcome Measures

Primary Outcomes (2)

  • Muscle activation (%MVIC)

    This was measured with wireless electromyography sensors electromiografía (BTS FreeEMG 1000, BTS Bioengineering, Milan, Italy).

    1 year

  • Ankle stability

    This was measured with force platform (Dynamic Walkway P6000, BTS Bioengineering, Milan, Italy).

    1 year

Secondary Outcomes (6)

  • Aye

    1 year

  • Gender

    1 year

  • Height

    1 year

  • Body weight

    1 year

  • Ankle functionality

    1 year

  • +1 more secondary outcomes

Study Arms (1)

Participants

Physiotherapy students of the Rovira i Virgili University aged between 18 and 35 years enrolled during the academic year 2022-2023. All participants were allowed three practice trials for each test. Consistent feedback was provided throughout to ensure proper technique. Electrodes were placed to assess muscle activity according to SENIAM recommendations in gluteus medius, gluteus maximus, tibialis anterior and peroneus longus. After electrode placement, a maximal isometric strength test (MVIC) was performed for each muscle to normalize the electromyographic data. During this MVIC test, the maximum isometric force was measured using the Chronojump Boscosystem force gauge. Following this, ankle stability evaluation tests were performed. The Single Leg Stance Test, the Hurdle Step test and finally the Single leg vertical jump will be performed.

Behavioral: Physical Therapy

Interventions

Physical TherapyBEHAVIORAL

Specific physical tests to assess muscle strength, ankle stability and activation of the lower extremity musculature: Single Leg Stance Test, Hurdle Step test and Single leg vertical jump.

Participants

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Health students from the Faculty of Medicine and Health Sciences of the Rovira i Virgili University.

You may qualify if:

  • To be between 18 and 35 years of age.
  • To sign the informed consent form.

You may not qualify if:

  • To have an injury at the time of selection.
  • To have psychological and/or psychiatric illnesses.
  • To take anticoagulants, to have an infectious process.
  • To have a heart disease.
  • To be hypersensitive to pain.
  • To have skin infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rovira i Virgili University

Tarragona, 43201, Spain

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Cristina Adillón, PhD

    University Rovira i Virgili

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2023

First Posted

November 2, 2023

Study Start

January 1, 2022

Primary Completion

June 30, 2023

Study Completion

September 30, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)