Static Stretching Exercises and Ultrasound Elastography Evaluation

March 20, 2024 updated by: Tahir Keskin , Pt, MSc, Suleyman Demirel University

Acute Effects of Static Stretching Exercises and the Mulligan Bent Leg Raise Technique on Hamstring Muscle Stiffness: an Ultrasound Elastography Evaluation

The aim of thid study was to compare two methods applied to increase the flexibility of the hamstring muscles and objectively evaluate changes in muscle stiffness using the two-dimensional shear wave ultrasound elastography (2D SWE) method. Thirty asymptomatic young individuals with hamstring shortness were divided into two groups by simple randomization. The Mulligan bent leg raise (BLR) technique was applied to the first group, and passive static stretching exercises to the second group. Hamstring flexibility was evaluated with the sit-and-reach test, and muscle stiffness with the 2D SWE method.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Merkez
      • Isparta, Merkez, Turkey, 32200
        • Süleyman Demirel Üniversitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Having a limitation of more than 25° in the active knee extension test
  • Only engaged in recreational sports during the study period

Inclusion Criteria:

  • Having a history of lower extremity injury within the last two years
  • Not volunteering to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mulligan bent leg raise technique
A single session of 3 repetitions of Mulligan bent leg raise was applied to the participants.
Other: Mulligan bent leg raise technique
In this study, while the participant was lying on his back on a high bed, the physiotherapist sat on the lateral side of the leg to be treated, placing the popliteal fossa of the participant's knee on his shoulder. The hip and knee of the leg to be stretched were placed in 90° flexion. Distraction was applied to the lower end of the femur, and the participant was asked to push the physiotherapist's shoulder with his leg and then relax. At this relaxation point, the physiotherapist pushed the flexed knee as far as possible in the direction of the ipsilateral shoulder in a painless range.
Experimental: Static stretching exercise
A single session of 5 repetitive stretching exercises was performed on the participants.
Other: Static stretching exercise
The participant lay on a stretcher in the supine position with his back straight. The physiotherapist placed the participant's leg on his shoulder with the knee in full extension and supported by the ankle and flexed the hip as much as possible until a tension was felt in the posterior thigh. This position was maintained for 30 seconds.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Back-saver sit-and-reach test
Time Frame: Up to 2 months
The difference between the back-saver sit-and-reach test and the classical sit-and-reach test is that the former is applied unilaterally. The test was administered using the sit-and-reach test box. The participants were asked to sit on a flat surface and rest the sole of one of their feet flat on the end of the box while keeping the other leg flat on the floor by flexing the knee and hips to 90° and 45° sequentially. Maintaining this position, they were asked to place one hand on the other with their palms facing down, slide their hands on the measuring board, slowly reach forward, wait for a second or two at the last point reached
Up to 2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Two-dimensional Shear Wave Elastography
Time Frame: Up to 2 months
All 2D SWE examinations were performed by a specialist radiologist using the Philips EPIQ-7 (EPIQ Elite Diagnostic Ultrasound System Release 7.0.5 Philips) device with an 18-4 MHz linear probe. These measurements were made with the patient lying in the prone position, with the knees in full extension, the ankle at the end of the stretcher, and the feet hanging down. The probe was placed longitudinally in the middle 1/3 of the hamstring muscles. The participants were asked to keep their muscles in a relaxed position, and no extra pressure was applied to the probe to avoid tissue compression that could artificially affect the measured tissue stiffness
Up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suleyman Demirel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SuleymanDUtahirkeskin03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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