Effect of Dynamic Taping on Landing Kinematics and Kinetics in Volleyball Players With Symptoms of Patellar Tendinopathy

October 27, 2022 updated by: Yi-Fen Shih, National Yang Ming University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11221
        • National Yang Ming University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham tape group
in supine, full knee extension position, apply the sham tape from the anterior inferior iliac crest to the middle of the lower leg
Device: 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
Experimental: Dynamic tape group
in supine, full knee extension position, apply the dynamic tape from the anterior inferior iliac crest to the middle of the lower leg
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
lower extremities joint angle
Time Frame: pre-intervention
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
lower extremities joint angle
Time Frame: immediately after the intervention
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
lower extremities joint angular velocity
Time Frame: pre-intervention
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
lower extremities joint angular velocity
Time Frame: immediately after the intervention
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
lower extremities joint angular acceleration
Time Frame: pre-intervention
lower extremities joint angular velocity divided by time
pre-intervention
lower extremities joint angular acceleration
Time Frame: immediately after the intervention
lower extremities joint angular velocity divided by time
immediately after the intervention
ground reaction force
Time Frame: pre-intervention
anterior, posterior, medial, lateral, vertical ground reaction force
pre-intervention
ground reaction force
Time Frame: immediately after the intervention
anterior, posterior, medial, lateral, vertical ground reaction force
immediately after the intervention
lower extremities joint force
Time Frame: pre-intervention
calculate the reaction force between segments
pre-intervention
lower extremities joint force
Time Frame: immediately after the intervention
calculate the reaction force between segments
immediately after the intervention
lower extremities joint moment
Time Frame: pre-intervention
calculate the reaction moment between segments
pre-intervention
lower extremities joint moment
Time Frame: immediately after the intervention
calculate the reaction moment between segments
immediately after the intervention
lower extremities joint power
Time Frame: pre-intervention
calculate the reaction moment between segments
pre-intervention
lower extremities joint power
Time Frame: immediately after the intervention
calculate the reaction moment between segments
immediately after the intervention
time to peak ground reaction force
Time Frame: pre-intervention
time period from initial contact to peak vertical ground reaction force
pre-intervention
time to peak ground reaction force
Time Frame: immediately after the intervention
time period from initial contact to peak vertical ground reaction force
immediately after the intervention
loading rate of ground reaction force
Time Frame: pre-intervention
peak vertical ground reaction force divided by time to peak ground reaction force
pre-intervention
loading rate of ground reaction force
Time Frame: immediately after the intervention
peak vertical ground reaction force divided by time to peak ground reaction force
immediately after the intervention
net joint work
Time Frame: pre-intervention
integral of joint power over time
pre-intervention
net joint work
Time Frame: immediately after the intervention
integral of joint power over time
immediately after the intervention
patellar tendon force
Time Frame: pre-intervention
knee joint moment divided by moment arm
pre-intervention
patellar tendon force
Time Frame: immediately after the intervention
knee joint moment divided by moment arm
immediately after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
lower extremities joint range of motion
Time Frame: before the landing tasks
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
lower extremities muscle force
Time Frame: before the landing tasks
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
lower extremities muscle length
Time Frame: before the landing tasks
iliopsoas, rectus femoris, hamstring, gastrocnemius and soleus muscle length test measured by the physical therapist
before the landing tasks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yi-Fen Shih, PhD, Department of Physical Therapy and Assistive Technology, National Yang-Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YM109067F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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