NCT06425185

Brief Summary

The goal of this observational study is to analyze the differences in muscle activation of six muscles of the lower leg (soleus, gastrocnemius medialis, gastrocnemius lateralis, tibialis anterior, peroneus longus, peroneus brevis) in seven possible configurations of a specific instability device, the Blackboard (BB), as well as on the floor, among healthy active subjects. The main questions it aims to answer are:

  1. 1.Which configuration of the BB produces the highest activation for each studied muscle?
  2. 2.Which muscle is the most activated in each configuration of the BB?
  3. 3.What is the muscle activation pattern obtained in each configuration of the BB?

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 Apr 2024

Shorter than P25 for all trials

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

April 9, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 22, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

May 12, 2024

Last Update Submit

May 31, 2024

Conditions

Keywords

Ankle stabilityMuscle activationInstability deviceHealthy

Outcome Measures

Primary Outcomes (1)

  • nEMG level of six leg muscles during single-leg stance across eight different conditions

    The electrode placement area will be shaved and cleaned with alcohol. Muscles analyzed will include soleus, gastrocnemius medialis, gastrocnemius lateralis, tibialis anterior, peroneus longus and peroneus brevis. The MuscleLab 4020e, Ergotest Technology AS surface electromyography device will be used, and adhesive electrode placement will follow SENIAM guidelines. Muscle activity will be recorded during 3 periods of 20" with 30" of rest in between. The single-leg stance will be done on the Floor condition and on the 7 instability configurations of the BB. The central 10" of the measurement will be used for subsequent analysis. The electromyography signal will be processed and cleaned, and the maximum value registered will be subsequently normalized by the muscle activation obtained during a maximal voluntary isometric contraction, yielding the normalized electromyography (nEMG) for each muscle. The average of the three attempts will be the value used for statistical analysis.

    Immediately after the MIVC test, during the single evaluation session, with an approximate duration of 30 minutes (20 minutes of measurement duration, plus time for familiarization and subject preparation)

Secondary Outcomes (1)

  • Maximum value of muscle activation of six leg muscles during a maximal voluntary isometric contraction

    Immediately after the warm-up, during the single evaluation session, with an approximate duration of 40 minutes (36 minutes of measurement duration, plus time for familiarization and subject preparation)

Study Arms (1)

Cross-sectional study group

The study group consists of 30 subjects who are free from any specific medical condition or injury affecting the lower extremities. These subjects are physically active individuals without any known musculoskeletal disorders or impairments. They all will be assessed in the same way. Data collection will take place during single-leg stance on the BB in its different configurations and on the floor. Three attempts of 20 seconds each will be recorded for each condition. The subjects will perform these exercises under the guidance of a trained physiotherapist.

Other: Single-leg stance under different instability conditions

Interventions

Participants will perform three attempts of 20 seconds of single-leg stance on the floor and on the 7 selected configurations of the BB. The order of measurement will be randomized. The description of the chosen configurations can be found in the Detailed Description section. In all cases, the participant's objective is to ensure that the edges of the BB are not in contact with the floor. The position of the participant on the BB will be a single-leg stance on the randomly chosen foot, with the contralateral knee slightly flexed and hands placed on the hips. Participants will look at a fixed point placed 3 meters in front of them. A rest period of 30 seconds will be allowed between trials. The physiotherapist responsible for supervising the measurements will be the one to adjust the BB configurations when needed.

Cross-sectional study group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The participants are being sourced from the Faculty of Physiotherapy of the University of Valencia. They are undergraduate or master's students who have responded to an email invitation sent by one of the professors from the department involved in the study.

You may qualify if:

  • Not to have experienced lower limb injury or pain within the last year prior to the study
  • Self-report as physically active, such that they perform at least 90 minutes of weekly physical activity

You may not qualify if:

  • Previous participation in any lower limb balance or proprioception exercise program
  • The presence of known balance impairments such as vertigo, vestibular or central alterations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rodrigo Martin-San Agustin

Valencia, Spain

Location

Study Officials

  • Rodrigo Martín-San Agustín, Doctor

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 12, 2024

First Posted

May 22, 2024

Study Start

April 9, 2024

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations