search
Back to results

Electrical Stimulation and Eccentric Exercise for Anterior Cruciate Ligament (ACL) Injury

Primary Purpose

Anterior Cruciate Ligament Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrical Stimulation
Eccentric Exercise
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring ACL, muscle, quadriceps, strength

Eligibility Criteria

14 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • MedSport

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

Experimental

Arm Label

Electrical stimulation

Standard of Care

Eccentric Exercise

Stimulation and Eccentrics

Arm Description

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.

This group will undergo standard ACL rehabilitation

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.

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.

Outcomes

Primary Outcome Measures

Quadriceps Strength

Secondary Outcome Measures

Central Activation Ratio
CAR = maximal voluntary isometric contractions force / maximal voluntary isometric contractions force + stimulated force

Full Information

First Posted
March 6, 2012
Last Updated
May 13, 2015
Sponsor
University of Michigan
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
search

1. Study Identification

Unique Protocol Identification Number
NCT01555567
Brief Title
Electrical Stimulation and Eccentric Exercise for Anterior Cruciate Ligament (ACL) Injury
Official Title
Quadriceps Inhibition After ACL Injury: Neuromuscular and Functional Consequences
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Neuromuscular electrical stimulation (NMES) has been shown to reduce quadriceps activation failure (QAF) and eccentric exercise has been shown to lessen muscle atrophy post-ACL reconstruction. Given thatthese are two critical components of quadriceps strength, intervention combining these therapies may be effective at reinstituting quadriceps function post-reconstruction. Therefore, the aim of this study is to evaluate the effectiveness of a combined NMES and eccentric exercise intervention to improve the recovery of quadriceps activation and strength post-reconstruction. Patients post ACL-injury will be placed into four treatment groups (NMES and eccentrics; eccentrics only; NMES only, and standard of care) Patients assigned to the NMES and eccentric and the NMES only groups will receive the NMES protocol 2× per week for the first 6 weeks post-reconstruction. MES and eccentric and the eccentrics only groups will receive the eccentric exercise protocol 2× perweek beginning 6 weeks post-reconstruction. Quadriceps activation was assessed via the superimposed burst technique and quantified via the central activation ratio.Quadriceps strength was assessed via maximal voluntary isomeric contractions (Nm/kg). Data will be gathered on three occasions: pre-operative, 12-weeks-post-surgery and at return-to-play.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury
Keywords
ACL, muscle, quadriceps, strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
This group will undergo standard ACL rehabilitation
Arm Title
Eccentric Exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Stimulation and Eccentrics
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Electrical Stimulation
Intervention Description
Electrical stimulation will be delivered 2 times per week
Intervention Type
Other
Intervention Name(s)
Eccentric Exercise
Intervention Description
Eccentric Exercise will be delivered 2 times per week
Primary Outcome Measure Information:
Title
Quadriceps Strength
Time Frame
Time of return to activity (~6 months following surgery)
Secondary Outcome Measure Information:
Title
Central Activation Ratio
Description
CAR = maximal voluntary isometric contractions force / maximal voluntary isometric contractions force + stimulated force
Time Frame
Time of return to activity (~6 months following surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 14-35 years Willingness to participate in testing and follow-up as outlined in the protocol Scheduled to undergo ACL reconstruction Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riann M Palmieri-Smith, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedSport
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26471854
Citation
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.
Results Reference
derived

Learn more about this trial

Electrical Stimulation and Eccentric Exercise for Anterior Cruciate Ligament (ACL) Injury

We'll reach out to this number within 24 hrs