Biomechanical PhenomenaNCT04480905
Effect of Dynamic Taping on Landing Kinematics and Kinetics in Volleyball Players With Symptoms of Patellar Tendinopathy
A study testing Dynamic tape in people with Biomechanical Phenomena, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Biomechanical Phenomena
- What is being tested?
- Dynamic tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jul 2020to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- at the age of 16 to 35 years old
- volleyball players joined the school team or professional level
- over 90 minutes of training time per week -
Who cannot join
- unbearable pain occurred at the patellar tendon when conducting landing tasks
- there are currently other acute injuries to the lower extremity
- lower extremity has undergone surgery or fracture in the past
- with a history of rheumatoid arthritis, systematic and neurological diseases -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Biomechanical Phenomena
- Being tested
- Dynamic tape, Sham tape
- Keywords
- patellar tendinopathy, volleyball, biomechanics, kinematics, kinetics, dynamic tape, landing, VISA-P, translation, Chinese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic tapeDevice
The dynamic tape will stick from anterior inferior iliac spine to the middle of the tibia in supine and full knee extension position
Sham tapeDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Sham tape group | Sham comparator | in supine, full knee extension position, apply the sham tape from the anterior inferior iliac crest to the middle of the lower leg Receives: Device: Sham tape |
| Dynamic tape group | Experimental | in supine, full knee extension position, apply the dynamic tape from the anterior inferior iliac crest to the middle of the lower leg Receives: Device: Dynamic tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre-intervention
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
Measured: immediately after the intervention
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
Measured: pre-intervention
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
Measured: immediately after the intervention
lower extremities joint angular acceleration
lower extremities joint angular velocity divided by time
Measured: pre-intervention
lower extremities joint angular acceleration
lower extremities joint angular velocity divided by time
Measured: immediately after the intervention
ground reaction force
anterior, posterior, medial, lateral, vertical ground reaction force
Measured: pre-intervention
ground reaction force
anterior, posterior, medial, lateral, vertical ground reaction force
Measured: immediately after the intervention
lower extremities joint force
calculate the reaction force between segments
Measured: pre-intervention
lower extremities joint force
calculate the reaction force between segments
Measured: immediately after the intervention
lower extremities joint moment
calculate the reaction moment between segments
Measured: pre-intervention
lower extremities joint moment
calculate the reaction moment between segments
Measured: immediately after the intervention
lower extremities joint power
calculate the reaction moment between segments
Measured: pre-intervention
lower extremities joint power
calculate the reaction moment between segments
Measured: immediately after the intervention
time to peak ground reaction force
time period from initial contact to peak vertical ground reaction force
Measured: pre-intervention
time to peak ground reaction force
time period from initial contact to peak vertical ground reaction force
Measured: immediately after the intervention
loading rate of ground reaction force
peak vertical ground reaction force divided by time to peak ground reaction force
Measured: pre-intervention
loading rate of ground reaction force
peak vertical ground reaction force divided by time to peak ground reaction force
Measured: immediately after the intervention
net joint work
integral of joint power over time
Measured: pre-intervention
net joint work
integral of joint power over time
Measured: immediately after the intervention
patellar tendon force
knee joint moment divided by moment arm
Measured: pre-intervention
patellar tendon force
knee joint moment divided by moment arm
Measured: immediately after the intervention
Secondary outcomes (3)
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
Measured: before the landing tasks
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
Measured: before the landing tasks
lower extremities muscle length
iliopsoas, rectus femoris, hamstring, gastrocnemius and soleus muscle length test measured by the physical therapist
Measured: before the landing tasks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start20 Jul 2020
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomechanical PhenomenaStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Fen Shih, National Yang Ming Chiao Tung University
- Investigators
- Yi-Fen Shih, PhD, Study director, Department of Physical Therapy and Assistive Technology, National Yang-Ming University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480905
- Sponsor's protocol ID
- YM109067F
- Status last verified
- Oct 2022
- First submitted
- 1 Jul 2020
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dynamic Taping on Landing Kinematics and Kinetics in Volleyball Players With Symptoms of Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT04480905
- Acronym / sponsor ID
- YM109067F
- Conditions
- Biomechanical Phenomena
- Keywords
- patellar tendinopathy, volleyball, biomechanics, kinematics, kinetics, dynamic tape, landing, VISA-P
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tape group | Sham comparator | Device: Sham tapein supine, full knee extension position, apply the sham tape from the anterior inferior iliac crest to the middle of the lower leg |
| Dynamic tape group | Experimental | Device: Dynamic tapein supine, full knee extension position, apply the dynamic tape from the anterior inferior iliac crest to the middle of the lower leg |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- at the age of 16 to 35 years old
- volleyball players joined the school team or professional level
- over 90 minutes of training time per week -
Key exclusion criteria (4 listed)
- unbearable pain occurred at the patellar tendon when conducting landing tasks
- there are currently other acute injuries to the lower extremity
- lower extremity has undergone surgery or fracture in the past
- with a history of rheumatoid arthritis, systematic and neurological diseases -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic tapeThe dynamic tape will stick from anterior inferior iliac spine to the middle of the tibia in supine and full knee extension position | Device | Dynamic tape group |
| Sham tapeThe 3M™ Soft Cloth Tape will stick from anterior inferior iliac spine to the middle of the tibia in supine and full knee extension position | Device | Sham tape group |
Primary outcome
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
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
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
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
lower extremities joint angular acceleration
Time frame: pre-intervention
lower extremities joint angular velocity divided by time
lower extremities joint angular acceleration
Time frame: immediately after the intervention
lower extremities joint angular velocity divided by time
ground reaction force
Time frame: pre-intervention
anterior, posterior, medial, lateral, vertical ground reaction force
ground reaction force
Time frame: immediately after the intervention
anterior, posterior, medial, lateral, vertical ground reaction force
lower extremities joint force
Time frame: pre-intervention
calculate the reaction force between segments
lower extremities joint force
Time frame: immediately after the intervention
calculate the reaction force between segments
lower extremities joint moment
Time frame: pre-intervention
calculate the reaction moment between segments
lower extremities joint moment
Time frame: immediately after the intervention
calculate the reaction moment between segments
lower extremities joint power
Time frame: pre-intervention
calculate the reaction moment between segments
lower extremities joint power
Time frame: immediately after the intervention
calculate the reaction moment between segments
time to peak ground reaction force
Time frame: pre-intervention
time period from initial contact to peak vertical ground reaction force
time to peak ground reaction force
Time frame: immediately after the intervention
time period from initial contact to peak vertical ground reaction force
loading rate of ground reaction force
Time frame: pre-intervention
peak vertical ground reaction force divided by time to peak ground reaction force
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
net joint work
Time frame: pre-intervention
integral of joint power over time
net joint work
Time frame: immediately after the intervention
integral of joint power over time
patellar tendon force
Time frame: pre-intervention
knee joint moment divided by moment arm
patellar tendon force
Time frame: immediately after the intervention
knee joint moment divided by moment arm
3 secondary outcomes
lower extremities joint range of motion
Time frame: before the landing tasks
lower extremities muscle force
Time frame: before the landing tasks
lower extremities muscle length
Time frame: before the landing tasks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Fen Shih, PhD study director
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic tape in people with Biomechanical Phenomena, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lower extremities joint angle (time frame: pre-intervention). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.