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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04480905
Other study ID # YM109067F
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 20, 2020
Est. completion date July 1, 2022

Study information

Verified date October 2022
Source National Yang Ming University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patellar tendinopathy (PT) is the common cause of anterior knee pain, particularly in sports required repeated jumping and landing, such as volleyball. PT clinically presents as anterior knee pain and localized tenderness at the patellar tendon. To evaluate the severity of symptoms of PT, the VISA-P questionnaire is a self-administered, well-validated, and widespread assessment tool. In the long term, athletes would land with knee avoidance patterns and transfer the load to the hip joint caused further hip-related injury. Lower extremities eccentric exercise has been proven the most beneficial treatment of PT. However, the course lasts for three to six months. For athletes who are still in season, it's difficult to get the immediate effect. A newly developed biomechanical taping, dynamic tape, considered to be beneficial for load absorption during muscle eccentric contraction during landing and further normalized the lower extremities load contribution by its viscoelasticity property. However, no past research has confirmed this effect. Therefore, the aims of the study are to translate the English VISA-P questionnaire to the Chinese and to study the reliability and validity of the Chinese version. In the next part, the investigators investigate the different landing biomechanics between individuals with and without patellar tendinopathy and establish the reliability of different landing tasks, and further explore whether the dynamic tape alters landing biomechanics in volleyball players.


Description:

Patellar tendinopathy is one of the most common causes of anterior knee pain, particularly common in sports that required repeated jumping and landing, such as volleyball and basketball. Patellar tendinopathy clinically presents as anterior knee pain and localized tenderness at the patellar tendon. To evaluate the severity of symptoms of patellar tendinopathy, the VISA-P (Victorian institution of sports assessment- patellar tendon) questionnaire is an easily self-administered, well-validated assessment tool and commonly used across several countries. In the long term, athletes would land with knee avoidance landing patterns and transfer the load to the hip joint, which caused the further hip-related injury. Lower extremities eccentric contraction exercise has been proven the most beneficial treatment of patellar tendinopathy. However, the course of treatment needs to last for three to six months. For athletes who are still in season, it's difficult to get the immediate effect. A newly developed biomechanical taping, dynamic tape, considered to be beneficial for load absorption during muscle eccentric contraction during landing and further normalized the lower extremities load contribution by its viscoelasticity property. However, no past research has confirmed this effect. Therefore, the aims of this study are to translate the English VISA-P questionnaire to Chinese and to study the reliability and validity of the Chinese version of the VISA-P. In the next part of the study, the investigators investigate the different landing biomechanics between individuals with and without patellar tendinopathy and establish the reliability of different landing tasks, and further explore whether the dynamic tape alters landing biomechanics in volleyball players. Methods: The first part of the study will include 15 subjects with the symptoms of patellar tendinopathy and 15 healthy subjects to fill out the translated questionnaire. In the second part of the study will include 15 volleyball players with the symptoms of patellar tendinopathy and 15 healthy controls. To compare the landing biomechanics between two groups, all subjects will conduct three landing tasks and the kinematics and kinetics of lower extremities、loading rate of vertical ground force and patellar tendon force will be recorded. In the third part of the study, the investigators will recruit 50 volleyball players with the symptoms of patellar tendinopathy and randomly assign to two groups, the dynamic tape, and sham tape. After taping, subjects will conduct three landing tasks, and the landing biomechanics will be recorded. Statistical analysis: Intra-class correlation, Pearson's correlation, and Mann-Whitney test will be used to analyze the test-retest reliability, concurrent validity, and construct validity of the Chinese version VISA-P. Repeated measures MANOVA will be used to analyze the interaction of landing biomechanics in three landing tasks between patellar tendinopathy group and healthy control, and further, analyze the interaction in three landing tasks between the dynamic tape and sham tape group in landing biomechanics parameters. Alpha level= 0.05


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date July 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 35 Years
Eligibility Inclusion Criteria: 1. at the age of 16 to 35 years old 2. volleyball players joined the school team or professional level 3. over 90 minutes of training time per week - Exclusion Criteria: 1. unbearable pain occurred at the patellar tendon when conducting landing tasks 2. there are currently other acute injuries to the lower extremity 3. lower extremity has undergone surgery or fracture in the past 4. with a history of rheumatoid arthritis, systematic and neurological diseases -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Dynamic tape
The dynamic tape will stick from anterior inferior iliac spine to the middle of the tibia in supine and full knee extension position
Sham tape
The 3M™ Soft Cloth Tape will stick from anterior inferior iliac spine to the middle of the tibia in supine and full knee extension position

Locations

Country Name City State
Taiwan National Yang Ming University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary lower extremities joint angle hip joint flexion, extension, abduction, adduction, internal rotation, external rotation angle, knee joint flexion, extension angle, ankle joint dorsiflexion, plantarflexion, inversion, eversion angle pre-intervention
Primary lower extremities joint angle hip joint flexion, extension, abduction, adduction, internal rotation, external rotation angle, knee joint flexion, extension angle, ankle joint dorsiflexion, plantarflexion, inversion, eversion angle immediately after the intervention
Primary lower extremities joint angular velocity hip joint flexion, extension, abduction, adduction, internal rotation, external rotation angle, knee joint flexion, extension angle, ankle joint dorsiflexion, plantarflexion, inversion, eversion angle divided by time pre-intervention
Primary lower extremities joint angular velocity hip joint flexion, extension, abduction, adduction, internal rotation, external rotation angle, knee joint flexion, extension angle, ankle joint dorsiflexion, plantarflexion, inversion, eversion angle divided by time immediately after the intervention
Primary lower extremities joint angular acceleration lower extremities joint angular velocity divided by time pre-intervention
Primary lower extremities joint angular acceleration lower extremities joint angular velocity divided by time immediately after the intervention
Primary ground reaction force anterior, posterior, medial, lateral, vertical ground reaction force pre-intervention
Primary ground reaction force anterior, posterior, medial, lateral, vertical ground reaction force immediately after the intervention
Primary lower extremities joint force calculate the reaction force between segments pre-intervention
Primary lower extremities joint force calculate the reaction force between segments immediately after the intervention
Primary lower extremities joint moment calculate the reaction moment between segments pre-intervention
Primary lower extremities joint moment calculate the reaction moment between segments immediately after the intervention
Primary lower extremities joint power calculate the reaction moment between segments pre-intervention
Primary lower extremities joint power calculate the reaction moment between segments immediately after the intervention
Primary time to peak ground reaction force time period from initial contact to peak vertical ground reaction force pre-intervention
Primary time to peak ground reaction force time period from initial contact to peak vertical ground reaction force immediately after the intervention
Primary loading rate of ground reaction force peak vertical ground reaction force divided by time to peak ground reaction force pre-intervention
Primary loading rate of ground reaction force peak vertical ground reaction force divided by time to peak ground reaction force immediately after the intervention
Primary net joint work integral of joint power over time pre-intervention
Primary net joint work integral of joint power over time immediately after the intervention
Primary patellar tendon force knee joint moment divided by moment arm pre-intervention
Primary patellar tendon force knee joint moment divided by moment arm immediately after the intervention
Secondary lower extremities joint range of motion hip flexion, extension, internal rotation, external rotation, abduction, adduction, knee flexion, ankle plantar flexion, dorsiflexion, eversion, inversion joint range of motion measured by the physical therapist with a goniometer before the landing tasks
Secondary lower extremities muscle force the hip flexor, extensor, internal rotator, external rotator, abductor, adductor, knee extensor, flexor, ankle plantar flexor, dorsiflexor, evertor, invertor muscle force measured by the physical therapist with a hand-held dynamometer before the landing tasks
Secondary lower extremities muscle length iliopsoas, rectus femoris, hamstring, gastrocnemius and soleus muscle length test measured by the physical therapist before the landing tasks
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