Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000728538p
Ethics application status
Submitted, not yet approved
Date submitted
1/03/2024
Date registered
13/06/2024
Date last updated
13/06/2024
Date data sharing statement initially provided
13/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimizing Rehabilitation: The Impact of Encouragement and Instruction on Return-to-Play and Injury Risk Assessment
Scientific title
A crossover study investigating the effect of instructional encouragement on force production and muscular activity in athletes during return-to-play test.
Secondary ID [1] 311655 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
muscle function 333112 0
Condition category
Condition code
Musculoskeletal 329796 329796 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 330144 330144 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Day 1: After an explanation of the test development, informed consent will be obtained. Subsequently, anthropometric assessments will be carried out. The placement of the electrodes will be done according to standardized locations for electromyography (EMG) measurements of the target muscle groups in accordance with SENIAM guidelines. Then, participants will complete a standard warm-up (mobility drills, 5' bike at moderate intensity)

Finally, a familiarization session with the equipment and test procedures will be conducted.


Assessment will be carried out for differents researcher blinded who only know what they have to apply.

Experimental conditions (CE) will be the next for all participants:
ENCOURAGE: only the participant will be encouraged to make maximum force production. (i.e "go,go,go)
EXPLICIT LEARINING: the instruction is intended to focus the participant's attention on producing strength with the specific musculature. (i.e "push with your quad")
ANALOGY LEARNING: the instruction is intended for the participant to think of a similar situation so that he creates a mental representation of the situation and his force production is oriented to it. (i.e "imagine that someone is grabbing you to keep you from moving. try to free yourself.")
CONTROL CONDITION: you are described how to do the test simply "i.e. you have to extend the knee and flex".

Day 2: The second visit will begin with a brief warm-up in an attempt to replicate the physiological conditions of the first visit. The electrodes will be repositioned to ensure data collection consistency. The testing phase for hip extension will start with a Maximum Voluntary Contraction (MVC) following Konrad 2005 guidelines. After a control condition, the randomized order of experimental conditions will be followed using specialized software. This sequence will then be replicated for CE1, CE2, and CE3 conditions. Three maximum repetitions will be performed. The isokinetic knee extension test will also follow the MVC > CEcontrol order, with randomization for the other 3 CE conditions. The speed will be set at 60°/s, and 3 repetitions will be performed to ensure adherence to instructions and prevent participants from generating their own rules.

The rest period between experimental conditions will be 10 minutes with the aim of reducing post-activation potential and fatigue resulting from the test contractions.

Afterthat, will be carried out the same protocol in a hip extension exercise (lying the participant in a supine position with extension during a maximal isometric contraction)

Time aproximation of the session will be 1 hour and half.

Mode of administration will be a one-on-one visit to the laboratory.


EMG during isokinetic knee extension will be assess over quad muscles and for hip extension test, semitendinous, major gluteus and erector spinae L1 level will be assessed.
Intervention code [1] 328115 0
Behaviour
Comparator / control treatment
This intervention will be a crossover study where all participants, at the beginning will be under control condition. Control condition consist in using a no instruction, just descriptive movement.
Control group
Active

Outcomes
Primary outcome [1] 337564 0
Isometric and isokinetic force will be measured as a composite outcome
Timepoint [1] 337564 0
The measurement of maximum isometric force will occur on second day.

On day 2, the measurement will be taken during the first experimental condition. After rest, experimental conditions will be carried out.

During isokinetic task, force production will be assessed during 6 repetitions in each EC.

During isometric hip extension task, force production will be assessed during 3 repetitions of 3 seconds in each EC.
Primary outcome [2] 337565 0
muscular activity during isokinetic knee extension task
Timepoint [2] 337565 0
assessed continuously throughout the isokinetic task
Primary outcome [3] 337899 0
muscular activity during isometric hip extension task
Timepoint [3] 337899 0
assessed continuously throughout the isometric task
Secondary outcome [1] 432337 0
Declarative knowledge.
Timepoint [1] 432337 0
After performing a task during an experimental condition, assistant will ask to participant about their focus of attention during the task.

Eligibility
Key inclusion criteria
participants of any gender, of legal age, will participate in the study. The main inclusion criteria will be have involved practicing sports in whatever level at the present time.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants with clinical issues as injuries or mental health disease that could affect during task.
Participants which not involved practicing sports at the present time.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Assignment was randomly created by software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be shown in the text as mean ± standard deviation. First, we will test the data for normality using the Shapiro-Wilk. Next, we compared changes between CONTROL, ENCOURAGEMENT, ANALOGY AND EXPLICIT experimental conditions using a one-way ANOVA repeated measures test. If a statistically significant value is observed, the Tukey post-hoc test will be used comparing between each of the conditions (i.e., CONTROL vs ANALOGY, ANALOGY vs EXPLICIT, CONTROL vs EXPLICIT...). We will use the partial eta-squared as a measure of effect size. Statistical significance will be set considering an alpha level of 0.05. All analyzes will be performed using JASP software (JASP Team-2020, Version 0.14.1). We will perform a power analysis to calculate what the statistical power is based on the number of participants recruited through G*POWER.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26182 0
Spain
State/province [1] 26182 0
Seville

Funding & Sponsors
Funding source category [1] 315983 0
Self funded/Unfunded
Name [1] 315983 0
Country [1] 315983 0
Primary sponsor type
Individual
Name
Angel Carnero
Address
Country
Spain
Secondary sponsor category [1] 318125 0
None
Name [1] 318125 0
Address [1] 318125 0
Country [1] 318125 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314805 0
Comité de Ética de la Investigación de la Universidad de Sevilla (CEIUS)
Ethics committee address [1] 314805 0
Ethics committee country [1] 314805 0
Spain
Date submitted for ethics approval [1] 314805 0
09/02/2024
Approval date [1] 314805 0
Ethics approval number [1] 314805 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132790 0
Mr Angel Carnero Diaz
Address 132790 0
Universidad de Sevilla. C/ Pirotecnia, s/n. CP 41013 Localidad SEVILLA
Country 132790 0
Spain
Phone 132790 0
+34666633451
Fax 132790 0
Email 132790 0
[email protected]
Contact person for public queries
Name 132791 0
Angel Carnero Diaz
Address 132791 0
Universidad de Sevilla. C/ Pirotecnia, s/n. CP 41013 Localidad SEVILLA
Country 132791 0
Spain
Phone 132791 0
+34666633451
Fax 132791 0
Email 132791 0
[email protected]
Contact person for scientific queries
Name 132792 0
Angel Carnero Diaz
Address 132792 0
Universidad de Sevilla. C/ Pirotecnia, s/n. CP 41013 Localidad SEVILLA
Country 132792 0
Spain
Phone 132792 0
+34666633451
Fax 132792 0
Email 132792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
data collected during the trial
When will data be available (start and end dates)?
Immediately following publication and with no end date
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
Universidad de Sevilla repository when DOI will be available or in [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21783Study protocol  [email protected]
21784Statistical analysis plan  [email protected]
21785Data dictionary  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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