search
Back to results

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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Shear Wave Ultrasound Elastography
The 3-D Motion Analysis
Electromyographic
Foot intrinsic muscle assessment and training device
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Strain of Fascia of Intrinsic Muscle of Foot (Disorder) focused on measuring Foot core system, Muscle stiffness, Motor control, Shear wave ultrasound elastography, Electromyography

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Athletes with plantar heel pain:

  1. Diagnosis of painful heel syndrome by clinical examination, with the following positive clinical signs:

    1. Pain in the morning or after sitting a long time
    2. Local pain where the fascia attaches to the heel
    3. Increasing pain with extended walking or standing for more than 15 minutes
  2. Was associated with inflammatory symptoms (pain, swelling, etc.)
  3. Pain in the area of the insertion of the plantar aponeurosis on the medial tubercle of the calcaneus.
  4. Not perform ankle stretching exercises as treatment of the plantar fasciitis.

Healthy individuals:

  1. 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.
  2. Foot Posture Index Score is between 0 and 5 .
  3. No pain in the lower limbs
  4. No history of lower limb injury or surgery that has affected function or caused the Individual to seek previous medical or therapeutic intervention.

Exclusion Criteria:

  1. 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
  2. History of spinal, pelvic or lower limb surgery
  3. Major neurological, cardiorespiratory or circulatory disorders
  4. Past history of traumatic head injury with or without loss of consciousness
  5. Have been taking non-steroidal anti-inflammatory or corticosteroid medication in the past month
  6. Recent intervention/management within the last 6 months

Sites / Locations

  • BuddhistTCGHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Shear Wave Ultrasound Elastography

The 3-D Motion Analysis

EMG acquisition system

Foot intrinsic muscle assessment and training device

Arm Description

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 )

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.

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.

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.

Outcomes

Primary Outcome Measures

Cross-sectional area (CSA)
Parameters of morphology (CSA) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm².
Cross-sectional area (CSA)
Parameters of morphology (CSA) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm².
Thickness
Parameters of morphology (thickness) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm.
Thickness
Parameters of morphology (thickness) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm.
Stiffness (RTE)
Parameters of morphology Stiffness (RTE) of intrinsic and extrinsic foot and selected hip muscles. The unit is kPa.
Stiffness (RTE)
Parameters of morphology Stiffness (RTE) of intrinsic and extrinsic foot and selected hip muscles. The unit is kPa.
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).
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).
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
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

Secondary Outcome Measures

Full Information

First Posted
April 21, 2020
Last Updated
December 2, 2022
Sponsor
Buddhist Tzu Chi General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04384003
Brief Title
Integrated Exercise Therapy Interventions on the Performance and Injury Prevention in Competitive Sports
Official Title
Integrated Proximal and Distal Joint Exercise Therapy Interventions on the Performance and Injury Prevention in Competitive Sports: Effects of Motor Control and Tissue Biomechanics
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The foot often plays a crucial role in sensorimotor control and movement performance in standing, walking, and running. Anatomically, the intrinsic foot muscles (IFM) are the primary local stabilizer to provide static and dynamic stability in the foot, which are part of the active and neural subsystems to constitute the foot core system. The intrinsic foot muscles (IFMs) may play a key role in supporting foot arches (e.g. the medial longitudinal arch, MLA), providing flexibility, stability, shock absorption to the foot, and partially controlling foot pronation. Due to the difficulties in teaching and learning the plantar intrinsic foot muscle (IFM) exercise, the accuracy and follow-up after learning this exercise could be questioned following this exercise program; Physiologically, the effects of exercise intervention may be achieved following more than 4-week intensive exercise intervention at least. How to learn and activating this kind of exercise efficiently and effectively is key for employing this exercise in young athletes with and without flexible flat feet. This project consists of two main parts - first, we aim to design and develop of novel intrinsic foot muscle strengthening device using 3-D printing techniques and to examine the feasibility and reliability of the morphology and neuromotor control features in intrinsic and extrinsic foot muscles before and after exercise intervention using Transcranial Magnetic Stimulation (TMS) and sonographic imaging in football /basketball athletes with without flexible flat feet (FFF); second, we will investigate whether immediate and persistent alterations in the morphology and motor control of IFMs and dynamic postural control after this therapeutic exercise with novel 3-D printing foot core exerciser. More importantly, we also elucidate important clinical evidence-based information on long-term novel therapeutic exercise intervention for coaches, clinicians, and health policymakers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
a single-blinded randomized controlled trial will be conducted, in which patients will be randomized into groups by sealed envelope method.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shear Wave Ultrasound Elastography
Arm Type
Active Comparator
Arm Description
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 )
Arm Title
The 3-D Motion Analysis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
EMG acquisition system
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Foot intrinsic muscle assessment and training device
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Shear Wave Ultrasound Elastography
Other Intervention Name(s)
AplioTM 300 Platinum
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
The 3-D Motion Analysis
Other Intervention Name(s)
Bonita, VICON Corp, UK,
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Electromyographic
Other Intervention Name(s)
TrignoTM, Delsys Corp. USA
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Foot intrinsic muscle assessment and training device
Other Intervention Name(s)
Schematic diagram of the novel modified foot intrinsic muscle (FIM) assessment and training device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cross-sectional area (CSA)
Description
Parameters of morphology (CSA) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm².
Time Frame
6 months
Title
Cross-sectional area (CSA)
Description
Parameters of morphology (CSA) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm².
Time Frame
12 months
Title
Thickness
Description
Parameters of morphology (thickness) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm.
Time Frame
6 months
Title
Thickness
Description
Parameters of morphology (thickness) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm.
Time Frame
12 months
Title
Stiffness (RTE)
Description
Parameters of morphology Stiffness (RTE) of intrinsic and extrinsic foot and selected hip muscles. The unit is kPa.
Time Frame
6 months
Title
Stiffness (RTE)
Description
Parameters of morphology Stiffness (RTE) of intrinsic and extrinsic foot and selected hip muscles. The unit is kPa.
Time Frame
12 months
Title
Joint kinematics and joint kinetics in the hip, knee and ankle joints will be calculated with the data
Description
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).
Time Frame
12 months
Title
Joint kinematics and joint kinetics in the hip, knee and ankle joints will be calculated with the data
Description
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).
Time Frame
6 months
Title
Electromyographic(EMG)
Description
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
Time Frame
6 months
Title
Electromyographic(EMG)
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chich-Haung Yang, PhD
Phone
+886-3-8565301
Ext
2496
Email
r.chyang@gms.tcu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Ya-Hui Su, BSc
Phone
+886-3-856-1825
Ext
12124
Email
irb@tzuchi.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chich-Haung R. Yang, PhD
Organizational Affiliation
College of Medicine, Tzu Chi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
BuddhistTCGH
City
Hualien City
ZIP/Postal Code
97004
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chich-Haung Yang, PhD
Phone
+886-3-8565301
Ext
2496
Email
r.chyang@gms.tcu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs