NCT04480905

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 28, 2022

Status Verified

October 1, 2022

Enrollment Period

1.9 years

First QC Date

July 1, 2020

Last Update Submit

October 27, 2022

Conditions

Keywords

patellar tendinopathyvolleyballbiomechanicskinematicskineticsdynamic tapelandingVISA-PtranslationChinese

Outcome Measures

Primary Outcomes (22)

  • 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

  • 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

  • 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

  • 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

  • lower extremities joint angular acceleration

    lower extremities joint angular velocity divided by time

    pre-intervention

  • lower extremities joint angular acceleration

    lower extremities joint angular velocity divided by time

    immediately after the intervention

  • ground reaction force

    anterior, posterior, medial, lateral, vertical ground reaction force

    pre-intervention

  • ground reaction force

    anterior, posterior, medial, lateral, vertical ground reaction force

    immediately after the intervention

  • lower extremities joint force

    calculate the reaction force between segments

    pre-intervention

  • lower extremities joint force

    calculate the reaction force between segments

    immediately after the intervention

  • lower extremities joint moment

    calculate the reaction moment between segments

    pre-intervention

  • lower extremities joint moment

    calculate the reaction moment between segments

    immediately after the intervention

  • lower extremities joint power

    calculate the reaction moment between segments

    pre-intervention

  • lower extremities joint power

    calculate the reaction moment between segments

    immediately after the intervention

  • time to peak ground reaction force

    time period from initial contact to peak vertical ground reaction force

    pre-intervention

  • time to peak ground reaction force

    time period from initial contact to peak vertical ground reaction force

    immediately after the intervention

  • loading rate of ground reaction force

    peak vertical ground reaction force divided by time to peak ground reaction force

    pre-intervention

  • loading rate of ground reaction force

    peak vertical ground reaction force divided by time to peak ground reaction force

    immediately after the intervention

  • net joint work

    integral of joint power over time

    pre-intervention

  • net joint work

    integral of joint power over time

    immediately after the intervention

  • patellar tendon force

    knee joint moment divided by moment arm

    pre-intervention

  • patellar tendon force

    knee joint moment divided by moment arm

    immediately after the intervention

Secondary Outcomes (3)

  • lower extremities joint range of motion

    before the landing tasks

  • lower extremities muscle force

    before the landing tasks

  • lower extremities muscle length

    before the landing tasks

Study Arms (2)

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

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

Device: Dynamic tape

Interventions

The dynamic tape will stick from anterior inferior iliac spine to the middle of the tibia in supine and full knee extension position

Dynamic tape group
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

Sham tape group

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming University

Taipei, 11221, Taiwan

Location

Study Officials

  • Yi-Fen Shih, PhD

    Department of Physical Therapy and Assistive Technology, National Yang-Ming University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 22, 2020

Study Start

July 20, 2020

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

October 28, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations