Viewing Study NCT06425185



Ignite Creation Date: 2024-06-16 @ 11:48 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06425185
Status: COMPLETED
Last Update Posted: 2024-06-03
First Post: 2024-05-12

Brief Title: Differences and Changes in Lower Limb Muscle Activation and Ankle Stability in Different Blackboard Configurations
Sponsor: University of Valencia
Organization: University of Valencia

Study Overview

Official Title: Differences in Electromyographic Activity of Ankle Stabilizer Muscles in the Different Configurations of a Specific Instability Device an Observational Study
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Which configuration of the BB produces the highest activation for each studied muscle
2 Which muscle is the most activated in each configuration of the BB
3 What is the muscle activation pattern obtained in each configuration of the BB

A single group of participants will be analyzed Both the studied leg and the order of configurations of the instability device and ground condition will be randomly assigned Participants will first undergo a 2-minute continuous walking warm-up followed by a performance of a maximum voluntary isometric contraction MVIC for each muscle during which the maximum activation produced will be recorded Each participant will be allowed a 30-second familiarization period on the most unstable configuration of the BB Three repetitions of 20 seconds will be recorded on both the ground and each configuration with a 30-second rest between repetitions The central 10 seconds of each trial will be used for subsequent analysis The mean of the three repetitions for each muscle will be calculated and subsequently processed and normalized by the maximum activation value during the MIVC

Finally a statistical analysis of the differences in muscle activation in each configuration will be conducted with the intention of addressing the mentioned questions
Detailed Description: The use of different instability devices is common in the clinical setting both for preventive and therapeutic purposes Numerous studies have demonstrated their effectiveness in improving stability and proprioception although in most cases in a generalized manner The need to selectively target specific structures and joints has led to the development of specific instability systems such as the Blackboard BB

The BB is an instability device composed of two rectangular wooden boards joined together with Velcro on its base where rounded slats can be freely placed to generate the desired instability according to the patients or subjects requirements It is known for its portability small size and adaptability and as demonstrated in a previous study similar to traditional devices BOSU or Wobble board in activating the Peroneus longus muscle essential for single-leg stability However its detailed functioning is still not fully understood as the muscle activation it produces during single-leg stance in its different configurations has not been analyzed yet

This study is a single-group cross-sectional observational study and it will include a sample of 30 participants who will be analyzed in a single session during single-leg stance on the floor and on the different configurations of the BB Electrode placement will follow SENIAM guidelines The session will begin with a 2-minute continuous walking warm-up followed by the recording of muscle activation in a maximum voluntary isometric contraction MVIC Subsequently the participant will be allowed a 30-second familiarization period on the most unstable configuration of the BB Total - see description below Muscle activation of six leg muscles soleus medial gastrocnemius lateral gastrocnemius tibialis anterior peroneus longus and peroneus brevis will be measured during single-leg stance on the different configurations of the BB and on the ground randomly

The analyzed variable will be muscle activation and the MuscleLab 4020e surface electromyography device from Ergotest Technology AS will be used The maximum value obtained during the central 10 seconds of the measurement which will last a total of 20 seconds will be recorded in three attempts with 30 seconds of rest between them

The hypothesis of this study is that by selecting a BB configuration that reinforces the expected muscle function based on ankle biomechanics its activation will increase Thus configurations that require movements such as eversion to increase activation of the peroneus longus and brevis or supination aiming to increase activation of the tibialis anterior among others will be analyzed The description of the different configurations is detailed below for the right foot

Floor single-leg stance on a firm surface in this case the floor
Rear single-leg stance on the BB with the front table fixed and the rear table with the slat placed centrally
Inver single-leg stance on the BB with the front table fixed and the rear table with the slat placed laterally demanding an inversion movement of the heel
Ever single-leg stance on the BB with the front table fixed and the rear table with the slat placed medially demanding an eversion movement of the heel
Sup single-leg stance on the BB with the rear table fixed and the front table with the slat placed laterally demanding a supination movement of the forefoot
Pro single-leg stance on the BB with the rear table fixed and the front table with the slat placed medially demanding a pronation movement of the forefoot
Fore single-leg stance on the BB with the rear table fixed and the front table with the slat placed centrally
Total single-leg stance on the BB with both the front and rear tables with the slats placed centrally

In all cases the subjects objective is to ensure that the edges of the BB are not in contact with the floor

Thus the aim of this study is to analyze the differences in electromyographic activity of the six studied muscles across the eight different conditions This includes identifying the most activated muscles in each condition and determining which condition produces the highest activation of each muscle Additionally a secondary aim is to establish patterns of muscular activation for each condition that is for each requested movement of the foot and ankle

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None