Effects of Foam Rolling, Foam Rolling with Dynamic Movement, and Static Stretching on Plantar Flexor Range of Motion and Tissue Properties in Healthy Participants

March 10, 2025 updated by: Ewan Thomas

Determinants of Acute Effects of Stretching Vs. Foam Rolling: Morphological, Sensory and Fluid Responses

Each voluntary participant will be invited and tested at the Functional Assessment Laboratory. After reading and completing the informed consent document regarding our research and data processing, participants will be invited for four separate sessions at the laboratory. During the first session, essential personal information (name, surname, sex, age) will be recorded. Immediately after measuring the participant's height using a stadiometer and weight using a scale, several tests will be conducted to assess pain thresholds and tissue density using specific dynamometers, joint mobility levels of the participants (Passive Muscle Mobility Test and a test using the accelerometer), and a Bioimpedance Analysis to assess body fluids. After a 15-minute rest period, the tests will be repeated to obtain an initial baseline control assessment. The subsequent sessions will involve the same evaluations, which will be conducted before, immediately after, and 15 minutes after the proposed intervention. The proposed interventions will be randomized across the sessions and will alternatively include: a brief session of static stretching on the leg muscles (4 sets of 30 seconds with 15 seconds of rest between sets), a session of static foam rolling (4 sets of 30 seconds with 15 seconds of rest between sets) on the same muscle groups, where pressure is applied to the muscle through the participant's body weight on a foam roller while performing muscle contractions, or dynamic foam rolling, during which the muscle will be rolled over the foam roller.

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.
24

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

  • Italy
    • PA
      • Palermo, PA, Italy, 90144
        • University of Palermo

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Healthy participants, adult participants, active, agreeing to sign the consent form

Exclusion Criteria:

Participants with neuromuscular, orthopedic and gynecological disease (or taking oral contraceptives) or those having injuries of the lower extremities were excluded from the investigation. Female participants were allowed to participate to the experiments only during the follicular phase of their menstrual cycle and always before ovulation

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

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: Static Stretching (SS)
For the SS, participants will be instructed to stand and place their dominant foot on a wedge with a 35° incline. They will stretch the plantar flexor muscles for 30 seconds, performing 4 repetitions.
Other: Static Stretching (SS)
For the SS, participants will be instructed to stand and place their dominant foot on a wedge with a 35° incline, stretching the plantar flexor muscles.
Experimental: Foam Rolling (FR)
For the FR, participants will be instructed to position the muscle belly of the PF on the roller. Thirty rolls (15 proximal and 15 distal) for a duration of 30 seconds will be considered one set.
Other: Foam Rolling (FR)
For the FR, participants will be instructed to position the muscle belly of the PF on the roller. Thirty rolls (15 proximal and 15 distal) will be performed on the muscle belly while maintaining compression on the muscle.
Experimental: Foam Rolling with Dynamic Movement (FR-DM)
The FR-DM will involve positioning the muscle belly of the PF on the roller and, without moving the roller, performing 15 plantar flexions and 15 dorsiflexions of the ankle for a period of 30 seconds while compressing the dominant leg with the contralateral leg.
Other: Foam rolling with dynamic movement (FR-DM)
The FR-DM will involve positioning the muscle belly of the PF on the roller and, without moving the roller, performing 15 plantar flexions and 15 dorsiflexions of the ankle for a period of 30 seconds while compressing the dominant leg with the contralateral leg.
No Intervention: Control Group (CG)
The CG will only perform the assessment tests, remaining seated for 4 minutes between the pre-test and post-test.

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
Plantar Flexors ROM
Time Frame: 5 minutes
Each participant was placed prone on a medical bed with both feet hanging out of the bed. Inelastic straps were used to fix the pelvis and the contralateral leg of the tested participant. A flat rigid surface was fixed on the sole of the foot. A two arm electronic goniometer (Digital Angle Ruler, resolution0.05°, accuracy±0.2°, repeatability0.05°) was then placed with one arm parallel to the flat surface positioned on the foot sole and the other arm following the diaphysis of the fibula. Starting position was set with the foot and the leg forming a 90°angle. The investigator passively pushed the foot into a dorsiflexion motion to the limit of available ROM, or the maximum tolerable pain for each participant.
5 minutes
Pain Pressure Thresholds
Time Frame: 5 minutes
PPT was assessed through a portable algometer(FPX25 Pain Tester, Wagner Instruments,CT,USA). The participant's measurement position and posture were similar to TH. The algometer was positioned perpendicular to the direction of the muscle fibers. The investigator pushed the metal rod of the algometer at a pressure of 1kg per second over the muscle belly of the participant. The participant was instructed to say "stop" when pain, rather than just pressure, was experienced.
5 minutes
Localised Bioimpedance Analysis (L-BIA)
Time Frame: 5 minutes
L-BIA was performed using a single frequency phase-sensitive device(BIA-101 Anniversary Sport Edition, Akern Systems, Firenze-Italy) at 50kHz and 400μA to measure PhA and vector length. Two pairs of electrodes (source(I) and detector(V) electrodes) were used. One pair was positioned on the upper part of the leg, with the lateral part of the I positioned on the popliteal crease(Lee et al., 2023) and the V, positioned caudally, parallel to I, 5cm apart. The other pair was positioned on the lower part of the leg with the lateral part of the I positioned above the tibial malleolus and the V, in a cranial direction parallel to I, 5cm apart. Prior to each test, the BIA measurements of the analyzer were validated using a precision circuit with acceptance for resistance(R) measurements of 383ohm(Ω) and reactance(Xc) values of 45Ω.
5 minutes
Drop Jump Height (DJ)
Time Frame: 5 minutes
A unilateral DJ was assessed through an Optojump™ system(Microgate, Bolzano, Italy) connected to a personal computer with dedicated software(OptojumpTM Next software). The system consists of two optical bars, a receiver and a transmitter, positioned 1m apart. The bars identify ground contact time(with a precision of 1ms) and then convert non-contact time into cm. Based on recommendations on optimal jump height(20 to 60cm), all jumps were performed from a box with a height of 40cm. Participants had to stand upright on the box with their hands positioned on their hips. At the "go" of the investigator, the participants had to jump forward from the box into the opto-jump system avoiding stepping down from the box or hopping off of the box. Once the participant reached the ground with their dominant limb, without flexing the knee, had to jump as high as possible. A 30s rest was given between each trial.
5 minutes

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.
Ewan Thomas

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.
October 30, 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.
May 30, 2024

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.
November 30, 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).
March 10, 2025

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.
March 10, 2025

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.
March 25, 2025

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 25, 2025

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 10, 2025

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, 2025

More Information

Terms related to this study

Keywords

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.
  • 170/2023

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

product manufactured in and exported from the U.S.

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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Conditions

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