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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05347303
Other study ID # "University of Jaén"
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 28, 2022
Est. completion date June 17, 2022

Study information

Verified date October 2022
Source University of Jaén
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Orthopedic Manual Therapy (OMT) is one of the branches of physiotherapy that has less evidence about its action and efficacy, but those who have had the opportunity to apply or receive it know its great benefits. Currently, worldwide, the approach given to physiotherapy goes hand in hand with the guidelines of the TMO, but in Colombia it is not seen in the same way. The objective of this TFM is to compare the effects of Finding-Oriented Orthopedic Manual Therapy combined with Foam Roller versus the effects of Foam Roller alone, specifically in terms of muscle power and lower limb flexibility in Colombian athletes. For this, a randomized controlled clinical trial will be carried out with two groups that will undergo different interventions. To measure the variables, the CMJ jump protocol will be used with the Optogait and the Wells or sit and reach test.


Description:

This research corresponds to an experimental study, a blind randomized controlled clinical trial, where a total of 87 people, men and women, of legal age, university athletes of collective disciplines, distributed in 2 groups will be evaluated: the experimental group will receive therapy with foam roller and with manual therapy guided by findings-oriented (n = 44) for 8 weeks, while the control (n = 43) will only receive the foam roller treatment. The variables will be measured with equipment and protocols validated in both groups. Evaluations will be made at the beginning of the intervention and immediately after the end of this period, all the data being unified in an Excel, assigning a code to each individual to maintain the privacy of the participants. As independent variables, sociodemographic data will be taken, as a result variable, the Maximum Repetition (RM) will be obtained following the protocol of a maximum repetition, the range of joint mobility using the goniometer pro app on an iPhone XR, flexibility with the Sit & Reach in V and the vertical jump measured with OptoGait. All variables will be measured pre and post intervention. As a result, manual therapy is expected to generate greater effects on the sports performance of university athletes in collective disciplines. Based on statistical processes, the data will be processed and it will be evaluated whether or not there are significant differences within and between groups.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date June 17, 2022
Est. primary completion date June 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Over 18 years of age. - Be active in any of the joint sports programs of the Fundación Universitaria del Área Andina headquarters Pereira - Colombia. - Voluntarily accept participation in the study. - Sign the consent informed. Exclusion Criteria: - Have a lower limb injury that may affect flexibility or muscle power. - Refuse to participate in the study. - Be under 18 years of age.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Finding-oriented orthopedic manual therapy treatment combined with foam roller
Blind randomized controlled clinical trial, where a total of 87 people, men and women, of legal age, university athletes of collective disciplines will be evaluated. The experimental group will receive foam roller therapy and manual therapy guided by findings (n = 44) for 8 weeks.
Foam roller treatment
Subjects will perform slides on the instrument using their body weight on the following muscles: quadriceps, hamstrings, gastrocnemius, and tensor fascia lata, for 60 seconds with 3 repetitions for each. Each repetition will have a rest period of 30 seconds, this will be done on both lower limbs.

Locations

Country Name City State
Colombia Andina Area University Foundation Pereira

Sponsors (1)

Lead Sponsor Collaborator
University of Jaén

Country where clinical trial is conducted

Colombia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Flexibility The sit and reach or Wells test is a test commonly used to measure the flexibility of the hamstring muscles and the posterior muscles in general (Mayorga-Vega et al., 2014). This test will be carried out following the guidelines of the American College of Sports Medicine (American College of Sport Medicine [ACSM], 2000). This test consists of placing the person evaluated sitting on the floor in front of a box with their feet resting on it without any type of footwear, keeping their knees fully extended, on the box there is a plate with a tape measure on which the person evaluated must place their hands, later they will perform a maximum trunk flexion trying to cover the greatest possible distance with their upper limbs without altering the rest of the position, if the person cannot reach the plate, the missing distance will be measured to be able to contact it and it will be presented as a negative value. Up to twelve weeks
Primary Joint range of motion The goniometer pro application available for iphone will be used. This tool has been previously tested and validated in the Latino population (Barboza et al., 2020). For this, the mobile device will be located with a system of straps that will ensure the position of the equipment on the segment to generate the displacement, once the individual is located in the starting position, the initial point will be selected in the application to then carry out the movement. The mobile device will then measure the displacement and give a measurement in degrees (°) that will be recorded. Up to twelve weeks
Primary Muscular Power The Optogate will be used, following the CMJ jump test, in which the subject stands in the middle of the instrument's optical led strips, adopts a position of knee and hip flexion where the knee joint forms an angle of 90 °, to ensure that it will be done in this way, it will be measured with a manual goniometer and a rope will be placed to give the subject a stimulus when he is in the correct position. In addition, you must place your hands on the waist and execute the jump in a single movement, fluid and without interruptions, before taking the measurements the subject will be allowed to become familiar with the test, in the first session. On measurement days, 3 jumps will be allowed and the one with the highest score will be considered valid. Up to twelve weeks
Primary Muscle strength Strength will be measured through the 1RM test, validated in different populations, regardless of gender or age (Grgic, Lazinica, Schoenfeld, & Pedisic, 2020). For the calculation of 1RM, the subjects will first receive an adaptation session, where they will get used to the gesture with low load so that after 2 days they can perform the real test. The actual test will consist of a warm-up with low resistance performing 10 repetitions of the exercise, then the load will be progressively increased until failure occurs, regardless of the verbal reinforcement given. A repetition will be considered successful when the subject performs the full range of motion without significant fasciculations or compensatory movements. The RM will be determined in 5 attempts for all subjects, all following the guidelines of the National Strength and Conditioning Association (Baechele & Earle, 2008). Up to twelve weeks
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