NCT04219917

Brief Summary

The purpose of this study is to explore the possible effects Kinesio Tape may have on proprioception in individuals with patellar tendonitis. A supportive knee application, a facilitative hip application, and a combination of the two will be applied and compared. Within and between group comparisons will be drawn. Participants will report for two research sessions with 24-36 hours between. Prior to arrival, they will complete a digital Victorian Institute of Sport Assessment for Patellar Tendonitis (VISA-P) and email it to the researcher. Participants must score less than 80 (out of a possible 100) to be considered for this study. If the individual meets the inclusion criteria, he/she will be scheduled for the 1st session. Upon arrival to the first session, informed consent will be obtained, the VISA-P will be reviewed, and intance of patellar tendonitis will be confirmed through palpation. Participants will then completed a Tampa Scale for Kinesiophobia (TSK) to measure fear of movement and a Visual Analog Scale (VAS) to measure overall pain. Height and weight measurments will be taken due to requirements of the Biodex Balance System (BBS), which will be used for balance measurements. Participants will take two, twenty-second practice tests, one with eyes open and one with eyes closed, followed by two minutes rest. Baseline testing will then be completed as follows: the participant will complete two tests with eyes open, and two tests with eyes closed on the injured leg, each with one minute rest between. The participant will then be taped with Kinesio Tape to either the hip, knee, or both the hip and knee according to the random group assignment. They will then rest for 15 minutes and complete a second round of balance testing with the same parameters as baseline testing. Participants will be scheduled for a second day no less that 24 hours and no more than 36 hours for re-test purposes. On the second day of testing, participants will be given $10 for their participation on Day 1. If they want to continue with testing procedures, they will participate in the same balance testing procedures as Day 1. The integrety of the tape application will be confirmed, and second TSK and VAS scale will be administered. A final round of balance testing will be completed, and the participant will receive an additional $10 if they choose to complete both days of testing. This research will allow us to compare results of the TSK, the VAS and the BBS testing both within subject and between group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 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

Study Start

First participant enrolled

December 20, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2020

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

January 3, 2020

Last Update Submit

November 30, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Tampa Scale for Kinesiophobia

    Measures fear of movement, score range 17-68, higher score means higher degree of kinesiophobia

    24 hours

  • Visual Analog Scale

    Measures overall pain, score range 1-10, higher score indicates more pain

    24 hours

  • Biodex Balance System

    Measures balance

    24 hours

Study Arms (3)

Hip

EXPERIMENTAL

Gluteus medius facilitation tape

Other: Kinesio Tape

Knee

EXPERIMENTAL

Patellar sling tape

Other: Kinesio Tape

Hip and Knee

EXPERIMENTAL

Gluteus medius facilitation and patellar sling tape

Other: Kinesio Tape

Interventions

Kinesio Tape will be applied to treat the pain associated with patellar tendonitis, to treat the cause of the pain, and to treat both factors.

HipHip and KneeKnee

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • score of less than 80 on the Victorian Institute of Sport Assessment for Patellar Tendonitis (VISA-P)
  • experienced patellar tendon pain for greater than 14 days
  • tender to palpation at the patellar tendon.

You may not qualify if:

  • knee surgery in the last six months
  • acute injury to the knee
  • any pain in the ankles, hips or core that may compromise balance testing
  • any allergy to adhesive
  • malignancies
  • cellulitis
  • skin infection
  • diabetes
  • fragile skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Dakota State University

Fargo, North Dakota, 58102, United States

Location

MeSH Terms

Interventions

Athletic Tape

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 7, 2020

Study Start

December 20, 2019

Primary Completion

February 18, 2020

Study Completion

February 18, 2020

Last Updated

December 4, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations