NCT07112534

Brief Summary

This study explores the effects of static stretching (SS) and foam rolling (FR) on the knee's range of motion (ROM) and balance, with particular reference to their application to the calf muscles and their possible influence through the myofascial chain known as the superficial back line (SBL). Balance is an essential skill for maintaining an upright posture and avoiding Falls, especially in people with chronic conditions. The knee plays a crucial role in load-bearing and locomotion, and its function can be limited by reduced muscle flexibility, particularly of the rectus femoris. To counteract this, SS and FR are commonly used strategies to improve ROM and are frequently employed in sports and rehabilitation settings. SS involves holding a muscle in an elongated position for a set period, while FR is a self-massage technique using a roller or massage bar that applies pressure to soft tissues through body weight. Both techniques have been shown to increase ROM, reduce muscle stiffness, and potentially improve athletic performance and recovery. The study also discusses the concept of tensegrity, fascia, and myofascial chains, which explain how different body structures are biomechanically connected. Fascia is described as a tissue capable of transmitting mechanical forces throughout the body, forming a continuum that supports and connects muscles, bones, and other structures. Evidence shows that tension can be transmitted through fascial connections, influencing movement and posture far from the point of force application. The SBL, described by Myers, connects the calf muscles with the hamstrings and posterior structures, implying that interventions on the calf could affect knee mobility similarly to direct hamstrings treatment. The research aimed to verify whether SS and FR protocols applied to the calves could produce similar benefits for knee ROM and balance as those applied to the hamstrings, based on their shared fascial connection. It also sought to compare the effectiveness of FR and SS, hypothesizing greater effects for FR due to its combined compression and stretching action. A total of 48 healthy subjects aged 20-40 years, with no recent lower limb injuries, were recruited and divided into four groups: hamstring static stretching (SSH), calf static stretching (SSC), hamstring foam rolling (FRH), and calf foam rolling (FRC). The interventions were standardized in terms of duration and intensità: 3 sets of 1 minute each with moderate intensity perceived as 7/10 on a discomfort scale, performed only on the dominant leg. SS was performed using classic stretching positions, while FR involved rolling from the popliteal fossa to the insert points of the target muscles using a BLACROLL® foam roller. Measurements included single-leg balance (SLB) test on a posturographic platform, knee ROM in flexion and extension using an inertial sensor, both before and 5 minutes after the intervention. Balance parameters analyzed were sway path length, sway ellipse surface, mean sway speed, and other center of pressure variables. Statistical analysis involved repeated-measures ANOVA for parametric variables and non-parametric ANOVA for balance parameters, with appropriate post hoc tests. The significance level was set at p\<0.05, and the effect size was assessed with partial eta squared. This research provides insights into the effectiveness of targeting different muscle groups within the same myofascial chain for improving knee mobility and balance. The results are expected to clarify whether indirect treatments of the calf can replicate the effects of direct hamstring protocols and whether FR can outperform SS in terms of increasing knee ROM and improving postural control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 21, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

July 21, 2025

Last Update Submit

August 1, 2025

Conditions

Keywords

Myofasial chainsPostural controlBalanceRange of motion

Outcome Measures

Primary Outcomes (2)

  • Evaluation of static balance via a posturographic platform

    The single-leg balance (SLB) test used a freeMed® platform (50 Hz) with freeStep® software. Subjects stood comfortably, then balanced on the dominant leg, flexing the other backward, arms at hips for 10 s. Extracted: sway path lenght (mm), sway ellipse surface (mm2), sway mean speed (mm/s), sway path length/sway ellipse surface, X/Y-medium (mm), ∆X (mm), ∆Y (mm).

    Complex 1 hour to complete both intervention and measurements (acute effects)

  • Assessment of knee flexion and extension range of motion using an inertial sensor

    Knee flexion ROM (º): prone on a couch, inertial sensor on medial malleolus, elastic at gluteals. Subjects flexed the dominant leg, heel to gluteus, head turned sideways, 3 reps; mean used. Knee extension ROM (º): supine with sensor, dominant leg on box, non-dominant extended; tibia actively extended upward, 3 reps, mean calculated.

    Complex 1 hour to complete both intervention and measurements (acute effects)

Study Arms (4)

foam rolling of the calf

OTHER

Foam rolling of the calf (dominante leg)

Other: Foam rolling

Static stretching of the calf

OTHER

Static stretching of the calf (dominant leg)

Other: Static stretching

foam rolling of the hamstring

OTHER

foam rolling of the hamstring (dominant leg)

Other: Foam rolling

Static stretching of the hamstring

OTHER

Static stretching of the hamstring (dominant leg)

Other: Static stretching

Interventions

Static stretching: 3 sets of 1 minute and 30 seconds of rest between sets

Static stretching of the calfStatic stretching of the hamstring

Foam rolling: 3 sets of 1 minute and 30 seconds of rest between sets

foam rolling of the calffoam rolling of the hamstring

Eligibility Criteria

Age20 Years - 40 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • no lower limb injuries in the 6 months before the start of the study, and no musculoskeletal disorders were recruited for this study

You may not qualify if:

  • lower limbs injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Palermo

Palermo, Italy, 90144, Italy

Location

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Antonino Bianco

    University of Palermo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

July 21, 2025

First Posted

August 8, 2025

Study Start

January 15, 2025

Primary Completion

February 28, 2025

Study Completion

June 15, 2025

Last Updated

August 8, 2025

Record last verified: 2025-08

Locations