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

• ClinicalTrials.gov Identifier: NCT04384003
• Recruitment Status: Recruiting
• First Posted: May 12, 2020
• Last Update Posted: May 12, 2020
• Sponsor: Buddhist Tzu Chi General Hospital
• Information provided by (Responsible Party): Buddhist Tzu Chi General Hospital

Tracking Information

• First Submitted Date: April 21, 2020
• First Posted Date: May 12, 2020
• Last Update Posted Date: May 12, 2020
• Actual Study Start Date: August 1, 2019
• Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 7, 2020)

• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

Brief Summary

Football is an increasingly popular exercise and common practice in 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 in musculoskeletal pain in the lower extremity. However, some conflicting issues such as assessment and training of foot intrinsic muscle in functional positions are still largely lack of device 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 development of novel intrinsic foot muscle assessment and training device in sporting tasks and to examine feasibility and reliability of muscle stiffness in foot and hip joint 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: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:

a single-blinded randomized controlled trial will be conducted, in which patients will be randomized into groups by sealed envelope method.

Primary Purpose: Prevention

Condition

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

Intervention

• Device: Shear Wave Ultrasound Elastography

  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).

  Other Name: AplioTM 300 Platinum
• Device: The 3-D Motion Analysis
  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).
  Other Name: Bonita, VICON Corp, UK,
• Device: Electromyographic
  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.
  Other Name: TrignoTM, Delsys Corp. USA
• Diagnostic Test: Foot intrinsic muscle 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.
  Other Name: Schematic diagram of the novel modified foot intrinsic muscle (FIM) assessment and training device

Study Arms

• Active Comparator: Shear Wave Ultrasound Elastography
  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 )
  Interventions:

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

  • Device: Shear Wave Ultrasound Elastography
  • Device: The 3-D Motion Analysis
  • Device: Electromyographic
  • Diagnostic Test: Foot intrinsic muscle assessment and training device
• Active Comparator: EMG acquisition system
  Interventions:

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

  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.

  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 7, 2020): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2020
• Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 40 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Chich-Haung Yang, PhD; +886-3-8565301 ext 2496; r.chyang@gms.tcu.edu.tw

• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT04384003
• Other Study ID Numbers: P00000801
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Buddhist Tzu Chi General Hospital
• Study Sponsor: Buddhist Tzu Chi General Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Buddhist Tzu Chi General Hospital
• Verification Date: August 2019