Rate of Force Development vs Isometric Strength of Quadri... | NCT04005274

Studies
Rate of Force Development vs Isometric Strength of Quadriceps

NCT04005274

Sponsor

Kaiser Permanente

Status

Completed

Last Update Posted

Jul 2, 2019Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Post ACL Reconstruction

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 8, 2019Actual

Primary Completion Date

Apr 8, 2019Actual

Completion Date

Apr 8, 2019Actual

First Submitted Date

Jun 20, 2019

First Submission Date that Met QC Criteria

Jul 1, 2019

First Posted Date

Jul 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2019

Last Update Posted Date

Jul 2, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Peak isometric strength of quadriceps (QI) has been used to help determine an athletes ability to safely return back to sport following an anterior cruciate ligament (ACL) reconstruction surgery. However, rate of force development (RFD) of the quadriceps, or how fast the quadriceps are able to reach their peak strength, is rarely used as part of this decision despite the role it plays in protecting the knee. This retrospective data only study will look back at the limb symmetry index (LSI) of patients post ACL reconstruction for the Noyes Hop Test, QI, and RFD. The hypothesis is that RFD does not recover at the same rate as Noyes Hop Test and QI.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Limb Symmetry (Noyes hop testing, Isokinetic testing-rate of force development, Isokinetic testing-quadriceps index)	Limb symmetry was calculated comparing surgical leg over non-surgical leg giving a percentage. A percentage will be calculated for each one of the 3 observations allowing easy comparison with same unit of measure.	March - June 2019

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No pain (at baseline) or edema/effusion
Full knee range of motion
Post Op: 20 weeks - 2 years
Non antalgic gait

Exclusion Criteria:

History of low back pain or other lower extremity injury within 1 year, skeletal immature, pregnant, concomitant ligament injury

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Kaiser Permanente patients attending out-patient physical therapy post ACL reconstruction.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Permanente West Los Angeles Medical Center		West Los Angeles	California	90034	United States