Integrated Exercise Therapy Interventions on the Performance and Injury Prevention in Competitive Sports

NCT04384003 | Unknown

• 1 other identifier: P00000801
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Football is an increasingly popular exercise and common practice among adolescent and elite athletes. However, these athletes tend to have injuries involving the lower extremity and foot. Recent literature has proposed a promising concept of core stability on the arch of the foot and proximal hip control exercise for a knee injury. They have highlighted that foot core training begins with targeting the plantar intrinsic muscles through exercise intervention, which may enhance the capacity and control of the foot core system. Moreover, it is hypothesized that the 'complexity algorithm' of exercise intervention for proximal hip control may provide more sufficient effects on musculoskeletal pain in the lower extremity. However, some conflicting issues such as assessment and training of foot intrinsic muscle in functional positions still largely lack devices and research to elucidate the underlying mechanism of its development and integrated exercise interventions proximally and distally on these athletes. Firstly, the investigators aim to design and develop of novel intrinsic foot muscle assessment and training device for sporting tasks and to examine the feasibility and reliability of muscle stiffness in foot and hip joints before and after exercise intervention using shear wave ultrasound elastography (SWUE) in athletes without and with foot and ankle overuse injuries; second, investigators will investigate whether immediate and persistent alteration after the integrated therapeutic exercise on motor control and muscle stiffness.

Conditions

Strain of Fascia of Intrinsic Muscle of Foot (Disorder); Elastography; Muscle Weakness

Keywords

Foot core system; Muscle stiffness; Motor control; Shear wave ultrasound elastography; Electromyography

Outcome Measures

Primary Outcomes (10)

• Cross-sectional area (CSA)

  Parameters of morphology (CSA) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm².

  6 months

• Cross-sectional area (CSA)

  Parameters of morphology (CSA) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm².

  12 months

• Thickness

  Parameters of morphology (thickness) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm.

  6 months

• Thickness

  Parameters of morphology (thickness) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm.

  12 months

• Stiffness (RTE)

  Parameters of morphology Stiffness (RTE) of intrinsic and extrinsic foot and selected hip muscles. The unit is kPa.

  6 months

• Stiffness (RTE)

  Parameters of morphology Stiffness (RTE) of intrinsic and extrinsic foot and selected hip muscles. The unit is kPa.

  12 months

• Joint kinematics and joint kinetics in the hip, knee and ankle joints will be calculated with the data

  Biomechanical data (i.e. joint kinematics such as joint angle and joint kinetics such as joint moments in the lower limb), center of pressure (CoP, i.e. the trajectory curve) and center of mass (CoM, i.e. the trajectory curve ) and electromyographic data (unit, percentage of maximal voluntary isometric contraction, MVIC) will be analyzed, respectively. Joint kinematics and joint kinetics in the hip, knee and ankle joints will be calculated with the data integrated from motion capture system (Nexus 2.0, Bodybuilder 3.6.4, Vicon Corp. UK ) and forceplates (Kistler, 9286B, Switzerland).

  12 months

• Joint kinematics and joint kinetics in the hip, knee and ankle joints will be calculated with the data

  Biomechanical data (i.e. joint kinematics such as joint angle and joint kinetics such as joint moments in the lower limb), center of pressure (CoP, i.e. the trajectory curve) and center of mass (CoM, i.e. the trajectory curve ) and electromyographic data (unit, percentage of maximal voluntary isometric contraction, MVIC) will be analyzed, respectively. Joint kinematics and joint kinetics in the hip, knee and ankle joints will be calculated with the data integrated from motion capture system (Nexus 2.0, Bodybuilder 3.6.4, Vicon Corp. UK ) and forceplates (Kistler, 9286B, Switzerland).

  6 months

• Electromyographic(EMG)

  Electromyographic variables (IEMG) between individuals with and without plantar heel pain (PHP) will be compared using a repeated-measures analysis of variance.measures analysis of variance

  6 months

• Electromyographic(EMG)

  Electromyographic variables (IEMG) between individuals with and without plantar heel pain (PHP) will be compared using a repeated-measures analysis of variance.measures analysis of variance

  12 months

Study Arms (4)

Shear Wave Ultrasound Elastography

ACTIVE COMPARATOR

Shear Wave Ultrasound Elastography (SWUE, AplioTM 300 Platinum, Toshiba Medical System Corp, Japan, 6I) to examine the morphology and mechanical properties (μ = ρVs2, μ is the shear modulus of the tissue, ρ is the density of muscle (1000 kg m-3), Young's modulus )

Device: Shear Wave Ultrasound Elastography; Device: The 3-D Motion Analysis; Device: Electromyographic; Diagnostic Test: Foot intrinsic muscle assessment and training device

The 3-D Motion Analysis

ACTIVE COMPARATOR

An optoelectronic-based 3D motion analysis system, including cameras, force plates, and an EMG system will be used in this study. A lower limb model (pelvis included) will be established through commercial motion analysis software (VICON Corp, UK). We will use this model to measure joint kinematics, joint kinetics, and ground reaction forces during functional activities, such as level walking.

Device: Shear Wave Ultrasound Elastography; Device: The 3-D Motion Analysis; Device: Electromyographic; Diagnostic Test: Foot intrinsic muscle assessment and training device

EMG acquisition system

ACTIVE COMPARATOR

Electromyographic signals measures will be focused on the Abductor Hallucis (AbdH), Peroneus Longus (PL) and Previous Brevis (PB), Gluteus Medius (Glut Med), and Gluteus Maximus (Glut Max). In order to reduce the cross-talk of other muscles in the foot, a miniature wireless surface EMG sensor (TrignoTM Mini Sensor, Delsys Inc. USA) will be used after confirmation of our previous research results.

Device: Shear Wave Ultrasound Elastography; Device: The 3-D Motion Analysis; Device: Electromyographic; Diagnostic Test: Foot intrinsic muscle assessment and training device

Foot intrinsic muscle assessment and training device

ACTIVE COMPARATOR

Schematic diagram of the novel modified foot intrinsic muscle (FIM) assessment and training device, which consists of one controller unit (signal generators, amplifier and A/D converter; signal generators provide noise-enhanced vibration to facilitate the muscle activation), 2 voice coil motor \& server, 2 optical rulers, 2 rail scale, and 7 load cells. The main concept for this design is to provide the quantitative assessment of the foot intrinsic muscles and facilitation of intrinsic muscles of the fool during functional sporting activities such single-leg-standing and kicking.

Device: Shear Wave Ultrasound Elastography; Device: The 3-D Motion Analysis; Device: Electromyographic; Diagnostic Test: Foot intrinsic muscle assessment and training device

Interventions

Shear Wave Ultrasound Elastography DEVICE

Scanned protocols of sonographic imaging will be used in this study to measure extrinsic (FDL, FHL and PER) and intrinsic (AbdH, FDB and FHB) muscle CSA and thickness, and plantar fascia thickness (at heel, mid and forefoot sites). The muscle stiffness will be calculated from the program provided by the US machine as shown real time elastography (RTE, unit: KPa).

Also known as: AplioTM 300 Platinum

EMG acquisition system; Foot intrinsic muscle assessment and training device; Shear Wave Ultrasound Elastography; The 3-D Motion Analysis

The 3-D Motion Analysis DEVICE

The 3-D Motion Analysis, Forceplates and EMG acquisition system and full body kinematic model (Bonita, VICON Corp, UK) in the Biomechanics and Motor Control Laboratory (BMCL).

Also known as: Bonita, VICON Corp, UK,

EMG acquisition system; Foot intrinsic muscle assessment and training device; Shear Wave Ultrasound Elastography; The 3-D Motion Analysis

Electromyographic DEVICE

Electromyographic activity (EMG) of AbdH, TA, PL, SO, gluteus medius (Glut Med) and gluteus maximus (Glut Max) will be recorded bilaterally using pairs of surface electrodes. Motor coordination of these muscles will be evaluated through assessment of temporal and spatial parameters of EMG during functional tasks such as kicking in one leg standing. The primary outcome measure will be percentage of EMG relative to maximal voluntary contraction (MVC) on the same side. In order to remove the potential for investigator bias, all data will be presented individually without identification of the muscle, order of trials or whether the trials precede or follow the intervention.

Also known as: TrignoTM, Delsys Corp. USA

EMG acquisition system; Foot intrinsic muscle assessment and training device; Shear Wave Ultrasound Elastography; The 3-D Motion Analysis

Foot intrinsic muscle assessment and training device DIAGNOSTIC_TEST

The main concept for this design is to provide the quantitative assessment of the foot intrinsic muscles and facilitation of intrinsic muscles of the fool during functional sporting activities such single-leg-standing.

Also known as: Schematic diagram of the novel modified foot intrinsic muscle (FIM) assessment and training device

EMG acquisition system; Foot intrinsic muscle assessment and training device; Shear Wave Ultrasound Elastography; The 3-D Motion Analysis

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Athletes with plantar heel pain:
• Diagnosis of painful heel syndrome by clinical examination, with the following positive clinical signs:
• Pain in the morning or after sitting a long time
• Local pain where the fascia attaches to the heel
• Increasing pain with extended walking or standing for more than 15 minutes
• Was associated with inflammatory symptoms (pain, swelling, etc.)
• Pain in the area of the insertion of the plantar aponeurosis on the medial tubercle of the calcaneus.
• Not perform ankle stretching exercises as treatment of the plantar fasciitis.
• Healthy individuals:
• A neutral foot alignment: determined by measurement of the resting calcaneal stance position (RCSP: between 2°of inversion and 2°of eversion) and scores on the navicular drop (ND: between 5 and 9 mm) test.
• Foot Posture Index Score is between 0 and 5 .
• No pain in the lower limbs
• No history of lower limb injury or surgery that has affected function or caused the Individual to seek previous medical or therapeutic intervention.

You may not qualify if:

• Traumatic injury to lower limbs which impacted joint integrity and function (i.e., fractures) resulting in at least 1 interrupted day of desired physical activity
• History of spinal, pelvic or lower limb surgery
• Major neurological, cardiorespiratory or circulatory disorders
• Past history of traumatic head injury with or without loss of consciousness
• Have been taking non-steroidal anti-inflammatory or corticosteroid medication in the past month
• Recent intervention/management within the last 6 months

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

BuddhistTCGH

Hualien City, 97004, Taiwan

RECRUITING

MeSH Terms

Conditions

Muscle Weakness

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Chich-Haung R. Yang, PhD

  College of Medicine, Tzu Chi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chich-Haung Yang, PhD

CONTACT

+886-3-8565301; r.chyang@gms.tcu.edu.tw

Ya-Hui Su, BSc

CONTACT

+886-3-856-1825; irb@tzuchi.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: a single-blinded randomized controlled trial will be conducted, in which patients will be randomized into groups by sealed envelope method.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 12, 2020
• Study Start: August 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)