Strain of Fascia of Intrinsic Muscle of Foot (Disorder)NCT04384003
Integrated Exercise Therapy Interventions on the Performance and Injury Prevention in Competitive Sports
A study testing Shear Wave Ultrasound Elastography, The 3-D Motion Analysis and Electromyographic in people with Strain of Fascia of Intrinsic Muscle of Foot (Disorder) and Elastography, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Strain of Fascia of Intrinsic Muscle of Foot (Disorder), Elastography, Muscle Weakness
- What is being tested?
- Shear Wave Ultrasound Elastography, The 3-D Motion Analysis and Electromyographic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.)
Show all 13Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
BuddhistTCGH
Hualien City, 97004
Chich-Haung Yang, PhD, +886-3-8565301 ext. 2496, r.chyang@gms.tcu.edu.tw
About this study
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
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.
Read the 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.
- Being tested
- Shear Wave Ultrasound Elastography, The 3-D Motion Analysis, Electromyographic, Foot intrinsic muscle assessment and training device
- Keywords
- Foot core system, Muscle stiffness, Motor control, Shear wave ultrasound elastography, Electromyography
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shear Wave Ultrasound ElastographyDevice
Also called AplioTM 300 Platinum
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).
The 3-D Motion AnalysisDevice
Also called Bonita, VICON Corp, UK,
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).
ElectromyographicDevice
Also called TrignoTM, Delsys Corp. USA
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.
Foot intrinsic muscle assessment and training deviceDiagnostic test
Also called Schematic diagram of the novel modified foot intrinsic muscle (FIM) assessment and training device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 ) Receives: 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. Receives: 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. Receives: 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. Receives: Device: Shear Wave Ultrasound Elastography; Device: The 3-D Motion Analysis; Device: Electromyographic; Diagnostic Test: Foot intrinsic muscle assessment and training device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional area (CSA)
Parameters of morphology (CSA) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm².
Measured: 6 months
Cross-sectional area (CSA)
Parameters of morphology (CSA) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm².
Measured: 12 months
Thickness
Parameters of morphology (thickness) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm.
Measured: 6 months
Thickness
Parameters of morphology (thickness) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm.
Measured: 12 months
Stiffness (RTE)
Parameters of morphology Stiffness (RTE) of intrinsic and extrinsic foot and selected hip muscles. The unit is kPa.
Measured: 6 months
Stiffness (RTE)
Parameters of morphology Stiffness (RTE) of intrinsic and extrinsic foot and selected hip muscles. The unit is kPa.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Aug 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strain of Fascia of Intrinsic Muscle of Foot (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chich-Haung R. Yang, PhD, Principal investigator, College of Medicine, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384003
- Sponsor's protocol ID
- P00000801
- Status last verified
- Nov 2022
- First submitted
- 21 Apr 2020
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04384003
- Acronym / sponsor ID
- P00000801
- Keywords
- Foot core system, Muscle stiffness, Motor control, Shear wave ultrasound elastography, Electromyography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Shear Wave Ultrasound Elastography | Active comparator | Device: Shear Wave Ultrasound Elastography, Device: The 3-D Motion Analysis, Device: Electromyographic, Diagnostic Test: Foot intrinsic muscle assessment and training deviceShear 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 ) |
| The 3-D Motion Analysis | Active comparator | Device: Shear Wave Ultrasound Elastography, Device: The 3-D Motion Analysis, Device: Electromyographic, Diagnostic Test: Foot intrinsic muscle assessment and training deviceAn 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. |
| EMG acquisition system | Active comparator | Device: Shear Wave Ultrasound Elastography, Device: The 3-D Motion Analysis, Device: Electromyographic, Diagnostic Test: Foot intrinsic muscle assessment and training deviceElectromyographic 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. |
| Foot intrinsic muscle assessment and training device | Active comparator | Device: Shear Wave Ultrasound Elastography, Device: The 3-D Motion Analysis, Device: Electromyographic, Diagnostic Test: Foot intrinsic muscle assessment and training deviceSchematic 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. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Diagnosis of painful heel syndrome by clinical examination, with the following positive clinical signs:
- 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.
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shear Wave Ultrasound ElastographyAlso: AplioTM 300 PlatinumScanned 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). | Device | EMG acquisition system, Foot intrinsic muscle assessment and training device, Shear Wave Ultrasound Elastography, The 3-D Motion Analysis |
| The 3-D Motion AnalysisAlso: Bonita, VICON Corp, UK,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). | Device | EMG acquisition system, Foot intrinsic muscle assessment and training device, Shear Wave Ultrasound Elastography, The 3-D Motion Analysis |
| ElectromyographicAlso: TrignoTM, Delsys Corp. USAElectromyographic 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. | Device | 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 deviceAlso: Schematic diagram of the novel modified foot intrinsic muscle (FIM) assessment and training deviceThe 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. | Diagnostic test | EMG acquisition system, Foot intrinsic muscle assessment and training device, Shear Wave Ultrasound Elastography, The 3-D Motion Analysis |
Primary outcome
Cross-sectional area (CSA)
Time frame: 6 months
Parameters of morphology (CSA) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm².
Cross-sectional area (CSA)
Time frame: 12 months
Parameters of morphology (CSA) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm².
Thickness
Time frame: 6 months
Parameters of morphology (thickness) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm.
Thickness
Time frame: 12 months
Parameters of morphology (thickness) of intrinsic and extrinsic foot and selected hip muscles. The unit is cm.
Stiffness (RTE)
Time frame: 6 months
Parameters of morphology Stiffness (RTE) of intrinsic and extrinsic foot and selected hip muscles. The unit is kPa.
Stiffness (RTE)
Time frame: 12 months
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
Time frame: 12 months
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
Time frame: 6 months
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)
Time frame: 6 months
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)
Time frame: 12 months
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chich-Haung R. Yang, PhD principal investigator
College of Medicine, Tzu Chi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shear Wave Ultrasound Elastography, The 3-D Motion Analysis and Electromyographic in people with Strain of Fascia of Intrinsic Muscle of Foot (Disorder) and Elastography, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chich-Haung Yang, PhD (+886-3-8565301 ext. 2496, r.chyang@gms.tcu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional area (CSA) (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.