Viewing Study NCT00451087



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Study NCT ID: NCT00451087
Status: UNKNOWN
Last Update Posted: 2008-01-30
First Post: 2007-03-22

Brief Title: Comparisons of Mechanical Properties of Tendon Structures
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: Phase 1 Study Comparison of Electromechanical Delay Phase 2 Study Research in Viscoelasticity of Tendon Structures Phase 3 Study Effects of Exercise Training in the Mechanical Properties
Status: UNKNOWN
Status Verified Date: 2006-12
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
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 PFPSWe 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 Youngs 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None