Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients

Browse trials for

• Flatfoot 171

Keywords

• Soft tissue
• Rehabilitation
• Physical therapy
• Ultrasound speckle tracking

Flatfoot

171 studies on the registry are indexed under Flatfoot; 42 are open to participants now.

This study's planned enrollment of 80 is above the median of 37 across 124 interventional studies indexed under Flatfoot.

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,608 studies on the registry; 573 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Athletes with BFlh Strain with Limited Return

  Athletes within 6 months of a unilateral biceps femoris long head (BFlh) muscle injury who have returned to the team but cannot fully participate in high-intensity training or competition. Participants complete an 8-week progressive Nordic hamstring exercise program (twice weekly, progressing from 3 sets of 6 to 3 sets of 12 repetitions) to evaluate changes in muscle displacement and eccentric knee flexor strength.

  Behavioral: Nordic Hamstring Exercise Training

• Experimental
  Adults with Symptomatic Adult Acquired Flatfoot Deformity

  Adults aged 18-80 years diagnosed with symptomatic flexible flatfoot (FPI-6 score \>= 6 or navicular drop \> 9 mm). Participants undergo 6 weeks of conservative therapy consisting of daily custom foot orthoses, progressive posterior tibial tendon eccentric training (twice weekly), daily short-foot exercises, and calf stretching, followed by evaluation at baseline, week 6, and week 12 follow-up.

  Behavioral: Custom Foot Orthoses and Exercise Therapy

• Experimental
  Overhead Athletes with Post-mUCL Reconstruction

  Overhead athletes aged 18-35 years who have undergone unilateral medial ulnar collateral ligament anterior bundle (mUCLAB) reconstruction and returned to training or competition. Participants complete an 8-week progressive isokinetic strength training program targeting the forearm flexor-pronator mass under blood flow restriction twice weekly.

  Other: Forearm Blood Flow Restriction Training

Interventions

• BehavioralNordic Hamstring Exercise Training

  An 8-week progressive Nordic hamstring curl exercise protocol performed twice weekly. Following initial technique instruction, participants perform progressive eccentric hamstring curls starting from 3 sets of 6 repetitions in weeks 1-2 and progressing to 3 sets of 12 repetitions in weeks 7-8.

• BehavioralCustom Foot Orthoses and Exercise Therapy

  A 6-week conservative program consisting of: (1) Wearing custom-molded foot orthoses daily during ambulatory activities; (2) Progressive eccentric posterior tibial tendon strengthening on an isokinetic dynamometer (twice a week, 3 sets of 15 repetitions); (3) Progressive short-foot exercises (30-40 repetitions daily); and (4) Gastrocnemius and soleus stretching.

• OtherForearm Blood Flow Restriction Training

  An 8-week progressive isokinetic strength training program targeting the forearm flexor-pronator muscles (pronator teres, flexor carpi ulnaris, brachialis) and handgrip, performed twice weekly. Exercises are performed under pneumatic blood flow restriction set at 70% limb occlusion pressure (LOP) of the brachial artery, at 40-60% of maximal voluntary isometric contraction (4 sets of 20 repetitions per muscle group).

Primary outcomes

1. Longitudinal Muscle Displacement of the Biceps Femoris Long Head (Arm 1)

   Longitudinal muscle displacement in millimeters of the middle biceps femoris long head (BFlh) tracked using ultrasound speckle tracking during a 20°/s maximal pain-free isokinetic eccentric knee flexion task.

   Time frame: Baseline and Week 8 post-intervention

2. Posterior Tibial Tendon Dynamic Torsion, Tendon Displacement, and Shear Wave Velocity (Arm 2)

   PTT dynamic torsion and displacement quantified using cross-sectional ultrasound speckle tracking during maximal isometric foot adduction, and tendon mechanical properties evaluated as mean shear wave velocity using shear wave elastography at proximal and distal tibialis posterior tendon.

   Time frame: Baseline, Week 6 (post-intervention), and Week 12 (follow-up)

3. Regional Strain of the Reconstructed mUCLAB Graft (Arm 3)

   Regional engineering strain along the longitudinal axis of the reconstructed medial ulnar collateral ligament anterior bundle (mUCLAB) across proximal, middle, and distal regions, quantified using ultrasound speckle tracking under a standardized 5 N·m dynamic valgus torque.

   Time frame: Baseline and Week 8 post-intervention

Secondary outcomes

1. Eccentric Knee Flexor Peak Torque (Arm 1)

   Maximal eccentric knee flexor peak torque (N·m) evaluated at 20°/s isokinetic velocity using an isokinetic dynamometer (Biodex Medical Systems, NY, USA) across a range of 90° to 0° knee flexion.

   Time frame: Baseline and Week 8 post-intervention

2. Functional Assessment Scale for Acute Hamstring Injuries (FASH) Score (Arm 1)

   Self-reported hamstring injury symptoms and physical function assessed using the FASH questionnaire. The score ranges from 0 to 100, where higher scores indicate superior hamstring function and less severity of symptoms.

   Time frame: Baseline and Week 8 post-intervention

3. Long Head of Biceps Femoris Muscle Shear Wave Velocity (Arm 1)

   Resting muscle stiffness quantified as shear wave velocity (m/s) at the suspected BFlh injury site and adjacent regions (1 cm proximal and distal) using shear wave elastography with a curved transducer.

   Time frame: Baseline and Week 8 post-intervention

4. Intramuscular Power Doppler Vascularity Grade (Arm 1)

   Vascularity around the suspected BFlh injury site evaluated using power Doppler ultrasonography on a 4-point ordinal scale: Grade 0 (no flow or 1 color pixel), Grade 1 (2-3 color pixels or 1 vessel), Grade 2 (2-3 vessels), and Grade 3 (\>3 vessels).

   Time frame: Baseline and Week 8 post-intervention

5. Intramuscular Scar Gap Size During Isometric Contraction (Arm 1)

   Measurement of the presence and gap size (mm) around the intramuscular scar tissue visualized in the longitudinal view under dynamic B-mode ultrasound during maximal voluntary isometric knee flexion at 30°.

   Time frame: Baseline and Week 8 post-intervention

6. Hamstring Flexibility (Arm 1)

   Hamstring flexibility evaluated via the active knee extension test in a supine 90-90 hip-knee position, recorded as the final achieved knee extension angle (in degrees, °) measured with a goniometer.

   Time frame: Baseline and Week 8 post-intervention

7. Revised Foot Function Index (FFI-R) (Arm 2)

   Patient-reported foot symptoms, pain, disability, and activity limitation evaluated via the Revised Foot Function Index (FFI-R), scored from 0 to 100 with higher scores reflecting greater impairment.

   Time frame: Baseline, Week 6 (post-intervention), and Week 12 (follow-up)

8. Musculoskeletal Health Questionnaire (MSK-HQ) Score (Arm 2)

   Overall musculoskeletal health status and quality of life assessed via the MSK-HQ. The total score ranges from 0 to 56, with higher scores representing better musculoskeletal health.

   Time frame: Baseline, Week 6 (post-intervention), and Week 12 (follow-up)

9. Visual Analog Scale (Arm 2)

   Patient self-reported foot pain intensity measured on a 100-mm Visual Analog Scale (VAS), where 0 mm indicates no pain and 100 mm indicates worst imaginable pain.

   Time frame: Baseline, each treatment session before/after, Week 6, and Week 12 (follow-up)

10. Single-Leg Heel-Rise Test (Arm 2)

    Functional performance of the posterior tibial muscle evaluated via the single-leg heel-rise test, documenting heel elevation height (cm) and the presence of heel inversion.

    Time frame: Baseline, Week 6 (post-intervention), and Week 12 (follow-up)

11. Maximal Voluntary Isometric Foot Inversion Torque (Arm 2)

    Maximal voluntary isometric foot inversion peak torque (N·m) measured using an isokinetic dynamometer (Biodex Medical Systems, NY, USA) with simultaneous electromyography monitoring to ensure isolation of the tibialis posterior.

    Time frame: Baseline, Week 6 (post-intervention), and Week 12 (follow-up)

12. Five-Minute Walk Test (Arm 2)

    Functional walking capacity evaluated as the total distance walked (in meters) within 5 minutes.

    Time frame: Baseline, Week 6 (post-intervention), and Week 12 (follow-up)

13. Y-Balance Test (Arm 2)

    Dynamic standing balance evaluated via the Y-balance test with the stance leg, recording foot excursion (in cm) during movement of the reach leg.

    Time frame: Baseline, Week 6 (post-intervention), and Week 12 (follow-up)

14. Countermovement Push-Up (CMPU) Maximal Vertical Force (Arm 3)

    Upper-extremity explosive strength and power assessed as maximal vertical ground reaction force (in Newtons) recorded on a portable force plate during the CMPU test.

    Time frame: Baseline and Week 8 post-intervention

15. Disabilities of the Arm, Shoulder, and Hand (DASH) Score (Arm 3)

    Subjective upper-extremity functional recovery and disability assessed using the Taiwan version of the DASH questionnaire, scored from 0 to 100 (higher scores indicate greater disability and symptom severity).

    Time frame: Baseline and Week 8 post-intervention

16. Regional Young's Modulus of Reconstructed mUCLAB (Arm 3)

    Tissue elasticity and stiffness (in kPa) of the reconstructed mUCLAB measured at the proximal, middle, and distal regions using shear wave elastography.

    Time frame: Baseline and Week 8 post-intervention

17. Shoulder and Elbow Maximal Voluntary Isometric Muscle Strength (Arm 3)

    Maximal voluntary isometric contraction strength (in Newtons or kilograms) of the shoulder and elbow muscle groups measured using a hand-held dynamometer (microFET®2, Hoogan Health Industries, West Jordan, UT, USA).

    Time frame: Baseline and Week 8 post-intervention

18. Shoulder and Elbow Active Range of Motion (Arm 3)

    Active range of motion (in degrees, °) of the shoulder (flexion, internal/external rotation) and elbow (flexion, extension, pronation, supination) measured using a standard universal goniometer.

    Time frame: Baseline and Week 8 post-intervention