NCT01555567

Brief Summary

Quadriceps muscle weakness is a common consequence of ACL injury. This muscle weakness is considered to result from neural inhibition preventing full muscle contraction and is referred to as arthrogenic muscle inhibition (AMI). AMI hinders rehabilitation by preventing gains in strength, increasing the risk of re-injury, and potentially placing patients at risk for chronic degenerative joint conditions. Quadriceps weakness that occurs following ACL injury is also thought to be caused by muscle atrophy which is thought to manifest due to alterations in muscle architecture, selective fiber atrophy or even neural deficits such as AMI. Importantly, interventions that are designed to counter this muscle weakness are required in order to promote long-term knee joint health. Hence, the purpose of the current study is to determine the efficacy of interventions that target quadriceps weakness to improve quadriceps muscle function and biomechanics in patients prior to and following ACL reconstruction. Specifically, the efficacy of neuromuscular electrical stimulation aimed at improving quadriceps neural activity and eccentric exercise intended to minimize quadriceps muscle atrophy will be investigated. The investigators expect that patients who receive the electrical stimulation therapy will demonstrate improvements in quadriceps strength and activation. Furthermore, it is expected that patients who receive both the electrical stimulation and eccentric intervention will demonstrate markedly greater gains in quadriceps strength and activation than patients who receive only the electrical stimulation therapy or standard of care post-surgery. The investigators also hypothesize that the patients who receive the electrical stimulation therapy and/or eccentrics will display knee motion similar to uninjured control subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

May 14, 2015

Completed
Last Updated

June 8, 2015

Status Verified

May 1, 2015

Enrollment Period

4.9 years

First QC Date

March 6, 2012

Results QC Date

April 26, 2015

Last Update Submit

May 13, 2015

Conditions

Anterior Cruciate Ligament Injury

Keywords

ACLmusclequadricepsstrength

Outcome Measures

Primary Outcomes (1)

  • Quadriceps Strength

    Time of return to activity (~6 months following surgery)

Secondary Outcomes (1)

  • Central Activation Ratio

    Time of return to activity (~6 months following surgery)

Study Arms (4)

Electrical stimulation

EXPERIMENTAL

Subjects placed into this group will undergo electrical stimulation following anterior cruciate ligament reconstruction (ACLr). Subjects will be required to report 2 times per week for 6 weeks following ACLr for electrical stimulation therapy. Electrical stimulation therapy post-reconstruction will commence immediately post-ACLr and end at week 6.

Device: Electrical Stimulation

Standard of Care

NO INTERVENTION

This group will undergo standard ACL rehabilitation

Eccentric Exercise

EXPERIMENTAL

Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.

Other: Eccentric Exercise

Stimulation and Eccentrics

EXPERIMENTAL

Subjects placed into this group will undergo a combined electrical stimulation and eccentric exercise intervention following ACLr. The electrical stimulation intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the electrical stimulation therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.

Device: Electrical StimulationOther: Eccentric Exercise

Interventions

Electrical StimulationDEVICE

Electrical stimulation will be delivered 2 times per week

Electrical stimulationStimulation and Eccentrics
Eccentric ExerciseOTHER

Eccentric Exercise will be delivered 2 times per week

Eccentric ExerciseStimulation and Eccentrics

Eligibility Criteria

Age14 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 14-35 years
  • Willingness to participate in testing and follow-up as outlined in the protocol
  • Scheduled to undergo ACL reconstruction

You may not qualify if:

  • Previous quadriceps injury
  • Inability to provide informed consent
  • Pregnant females
  • ACL injury sustained more than 48 hours prior to reporting to physician
  • ACL injury sustained when not engaged in sports participation (i.e. while engaged in activities of daily living)
  • Previous partial ACL tear
  • Previous surgery to injured knee
  • Total or partial meniscectomy accompanying ACL reconstruction
  • Other ligamentous injury accompanying ACL injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedSport

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Lepley LK, Palmieri-Smith RM. Quadriceps Strength, Muscle Activation Failure, and Patient-Reported Function at the Time of Return to Activity in Patients Following Anterior Cruciate Ligament Reconstruction: A Cross-sectional Study. J Orthop Sports Phys Ther. 2015 Dec;45(12):1017-25. doi: 10.2519/jospt.2015.5753. Epub 2015 Oct 15.

    PMID: 26471854DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Results Point of Contact

Title
Riann Palmieri-Smith
Organization
University of Michigan
riannp@umich.edu
7346153154

Study Officials

  • Riann M Palmieri-Smith, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 15, 2012

Study Start

August 1, 2009

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 8, 2015

Results First Posted

May 14, 2015

Record last verified: 2015-05

Locations

US(1)