ClinicalTrials.gg
Status unknownNCT00451087Updated Jan 30, 2008

Comparisons of Mechanical Properties of Tendon Structures

A Phase 1 interventional study of leg press training and isokinetic training in Patellofemoral Pain Syndrome, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged Up to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-01-30.

Sponsored by National Taiwan University Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
Up to 49 Years
Sex
All
01

Study summary

We assume the etiology of patellofemoral pain syndrome is related to mechanical properties of tendon structures of the vastus medialis obliquus and vastus lateralis. Consequently, we will measure the electromechanical delay and some viscoelastic parameters of the two muscles. Besides, we will also investigate the effects of exercise training to the mechanical properties of the muscles.

Read the detailed description

Patellofemoral pain syndrome (PFPS) is a common knee disorder. From the literature review, one may find inconsistent results among different research or clinical studies on the effect of therapeutic exercise for the patients with PFPS. A possible reason for the disagreement might be lack of a clear etiology of patellofemoral pain. At present, the most widely accepted concept for the genesis of patellofemoral pain is abnormal lateral tracking of the patella. One factor that causes this maltracking is soft tissue imbalance around the patella. Previous studies demonstrating the inconsistency of the amplitude of muscle activity and the timing of muscle firing for vastus medialis obliquus (VMO) and vastus lateralis (VL) may contribute to the imbalance of soft tissue. Another neuromuscular condition, however, the electromechanical delay of VMO and VL in patents with PFPS was not investigated extensively. We hypothesized that people with PFPS would have longer electromechanical delay of VMO than that of VL. The objective of this three-year project is to compare the electromechanical delay of VMO with that of VL in people with PFPS for the first year. In the second year, we will further investigate the viscoelastic properties of tendon structures, the key components induced this electromechanical delay, of VMO and VL in vivo. In the last year, we will research the effect of an exercise program on the mechanical properties of VMO and VL in people with PFPS.We expect to recruit 30 patients with PFPS as an experimental group and 30 healthy individuals as a control group in the both first and second years. In the third year, we will recruit 60 patients with PFPS, 30 of them to receive a specific exercise program and the others are in the control group.

The evoked electromechanical delay of VMO is defined as the time interval between the time when VMO receiving an electrical stimulation and the onset time of patellar movement due to the VMO contraction. The viscoelastic properties of tendon structures are investigated by an ultrasonographic study under voluntary contraction conditions. The torque output during isometric knee extension at 80° of flexion is measured by a dynamometer. The subject is instructed to produce a gradually increasing force from relaxed status to maximal voluntary contraction within 5 seconds, followed by a gradual relaxation also within 5 seconds. Simultaneously, the elongation of the deep aponeurosis of the VMO or VL is caught by the ultrasonic image which is synchronized with the torque signal by a clock timer for subsequent analysis. The stiffness, Young's modulus and hysteresis of the tendon structures are calculated to represent its viscoelastic properties.

Finally, the subject is prescribed an 8-week exercise program by EN-dynamic machine to perform knee extension from 45° to 0° of flexion. The training outcome is assessed with electromechanical delay of VMO and VL. And we will also investigate the effect of the exercise program on the mechanical properties of tendon structures.

02

Conditions studied

  • Patellofemoral Pain Syndrome

Keywords

  • mechanical properties
  • electromechanical delay
  • viscoelasticity
  • VMO
  • patellofemoral pain syndrome
03

In context

Patellofemoral Pain Syndrome

299 studies on the registry are indexed under Patellofemoral Pain Syndrome; 74 are open to participants now.

This study's planned enrollment of 120 is above the median of 46 across 246 interventional studies indexed under Patellofemoral Pain Syndrome.

Browse Patellofemoral Pain Syndrome studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,609 studies on the registry; 574 are open to participants now.

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

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Below 50 years old.
  2. Subjects have at least two of five conditions of knee pain: to squat down, to go or down stairs, to keep prolong sitting position, to be palpated the joint cartilage of patella, to be test by Clark sign.
  3. Subjects have the symptoms for 3 months at least.

Exclusion criteria

Exclusion Criteria:

  1. Subjects have the other knee disorder in addition to PFPS.
  2. Subjects had ever received operations of knee in past 3 months.
  3. Subjects have neurological disease.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    1

    Procedure: leg press training

  • Active comparator
    2

    Procedure: isokinetic training

Interventions

  • Procedureleg press training

    quadriceps muscle strengthening. 30min/ 3times/ week

  • Procedureisokinetic training

    quadriceps muscle training. 30 min/ 3 times/ week

06

What researchers measure

Primary outcomes

  1. electromechanical delay

    Time frame: minisecond

Secondary outcomes

  1. quadriceps muscle force

    Time frame: second

  2. the displacement of deep aponeurosis of vasti muscles

    Time frame: second

07

Study locations

1 of 1 sites recruiting
  • Kinesiology Laboratory
    Taipei, 100, Taiwan
    Recruiting
08

References and documents

Publications

  • Cowan SM, Hodges PW, Bennell KL, Crossley KM. Altered vastii recruitment when people with patellofemoral pain syndrome complete a postural task. Arch Phys Med Rehabil. 2002 Jul;83(7):989-95. doi: 10.1053/apmr.2002.33234. PubMed 12098160 ↗
  • Kubo K, Kanehisa H, Kawakami Y, Fukunaga T. Elastic properties of muscle-tendon complex in long-distance runners. Eur J Appl Physiol. 2000 Feb;81(3):181-7. doi: 10.1007/s004210050028. PubMed 10638375 ↗
  • Chen HY, Chien CC, Wu SK, Liau JJ, Jan MH. Electromechanical delay of the vastus medialis obliquus and vastus lateralis in individuals with patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2012 Sep;42(9):791-6. doi: 10.2519/jospt.2012.3973. Epub 2012 Aug 2. PubMed 22951377 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00451087
First posted
Mar 23, 2007
Start date
Dec 2006
Primary completion
Mar 2007
Completion
Sep 2009 (estimated)
Last update
Jan 30, 2008

Study contacts

Mei-Hwa Jan, Master
Contact
mhjan@ntu.edu.tw
886-2-33228138
Mei-Hwa Jan, Master
study director · School and Graduate Institude of Physical Therapy,NTU

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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