NCT01460004

Brief Summary

The purpose of this study is:

  • To examine the effect of infra patellar strap treatment on the extent of pain and jumping performance tasks in young male athletes diagnosed with patellar tendinopathy.
  • 40 elite male athletes, basketball and volleyball players, ages 14-18, students of the academy for sports Excellency will take part in this study
  • Hypothesis 1: The treatment of infra patellar strap will reduce the level of pain during jumping performance tasks.
  • Hypothesis 2: The treatment of infra patellar strap will improve the squat jump height in athletes with patellar tendinopathy during squat jump task.
  • Hypothesis 3: The treatment of infra patellar strap will improve the drop jump height in athletes with patellar tendinopathy during drop jump task.
  • Hypothesis 4: The treatment of infra patellar strap will improve the one leg jump height in athletes with patellar tendinopathy during one leg jump task.
  • Hypothesis 5: The treatment of infra patellar strap will improve the 30 seconds repetitive jumps mean height in athletes with patellar tendinopathy during 30 seconds repetitive jumps task.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

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

October 5, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

2.9 years

First QC Date

October 5, 2011

Last Update Submit

July 16, 2015

Conditions

Keywords

patellar tendinopathyjumper's knee

Outcome Measures

Primary Outcomes (1)

  • change in pain level after applying an infra patellar strap

    level of pain ranked upon visual analog scale by the subject

    Within a week from primary physical therapist examination and including in the study. Measures will be taken Before, during and after jump tasks with and without the infra patelar strap, during one session.

Secondary Outcomes (1)

  • change in height of jump after applying an infra patellar strap

    Within a week from primary physical therapist examination and including in the study. while performing the jumps tasks with and without the infra patellar strap. All measures will be collected during one session, without follow-up.

Study Arms (1)

patella knee strap

NO INTERVENTION

infra patella knee strap- cotton, applied in straight leg

Device: patella knee strap

Interventions

infra patella strap 100% cotton pressure is exerted immediately under the patella

Also known as: FDA regulation number 890.3475
patella knee strap

Eligibility Criteria

Age14 Years - 18 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • elite male athlete
  • basketball and volleyball player
  • ages 14-18
  • clinical diagnosis of patellar tendinopathy
  • able to jump

You may not qualify if:

  • undergo a surgical procedure in knee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wingate Institute

Netanya, 42902, Israel

Location

Study Officials

  • gali dar, Phd

    Wingate Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professional director, Sports Medicine Sciences and Research,

Study Record Dates

First Submitted

October 5, 2011

First Posted

October 26, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations