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MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation (MiACLR)

Primary Purpose

Anterior Cruciate Ligament Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation (NMES)
Eccentric Exercise (ECC)
Neuromuscular Electrical Stimulation (NMES) placebo
Eccentric Exercise (ECC) placebo
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 Knee, ACL, Reconstruction, Rehabilitation, Eccentric Exercise, Electrical Stimulation

Eligibility Criteria

14 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute, complete ACL rupture
  • ACL reconstruction with autograft
  • Scheduled to undergo ACLR at U of Michigan
  • Willingness to participate in testing and follow-up as outlined

Exclusion Criteria:

  • Previous surgery to either knee
  • Bony fracture accompanying ACL injury
  • Patients who experienced a knee dislocation
  • Female participants who are pregnant or planning pregnancy

Sites / Locations

  • MedSportRecruiting
  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NMES+ECC

NMES placebo + ECC placebo

Arm Description

Neuromuscular electrical stimulation (NMES) and Eccentric Exercise (ECC). Patients randomized to the NMES+ECC group will first receive NMES for 2x/week for 8 weeks, beginning at the first post-operative visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive eccentric exercise 2x/week for an additional 8 weeks. For NMES, patients will have electrical stimulation delivered to their quadriceps. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For eccentric exercise, patients will train for 4 sets of 10 repetitions. This group will also receive standard of care ACL rehabilitation alongside the study interventions.

Neuromuscular electrical stimulation (NMES) placebo + Eccentric Exercise (ECC)placebo arm. Patients randomized to the NMES placebo + ECC placebo group will first receive NMES placebo for 2x/week for 8 weeks, beginning at the first post-operative physical therapy visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive an eccentric exercise placebo 2x/week for 8 weeks. For the NMES placebo, patients will have NMES placebo delivered to their quadriceps 2x/week for 8 weeks beginning at the first post-operative visit. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For the eccentric exercise placebo, patients will begin to receive eccentric exercise two times per week for 8 weeks. Patients will train for 4 sets of 10 repetitions.

Outcomes

Primary Outcome Measures

Change from baseline to 6 months isokinetic quadriceps strength index
concentric isokinetic muscle strength at 60 degrees per second
Change from baseline to 18 months isokinetic quadriceps strength index
concentric isokinetic muscle strength at 60 degrees per second

Secondary Outcome Measures

T1 rho relaxation time symmetry scores for knee joint cartilage
[T1rho value from MRI for right knee (msec)/T1rho value for left knee (msec)] x 100
T2 relaxation time symmetry scores for knee joint cartilage
[T2 value from MRI for right knee (msec)/T2 value for left knee (msec)] x 100
Knee Flexion Angle at 6 months
Peak knee flexion angle recorded during a single-legged hop (units: degrees)
Knee Flexion Angle at 18 months
Peak knee flexion angle recorded during a single-legged hop (units: degrees)
Knee Flexion Moment at 6 months
Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)
Knee Flexion Moment at 18 months
Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)

Full Information

First Posted
August 8, 2018
Last Updated
October 24, 2022
Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Connecticut, University of Delaware, University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT03626857
Brief Title
MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
Acronym
MiACLR
Official Title
MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Connecticut, University of Delaware, University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial evaluates interventions to maximize muscle function and improve cartilage health following anterior cruciate ligament reconstruction. Improving muscle function may improve patient outcomes, improve joint mechanics, and potentially serve as a prevention approach for post-traumatic knee osteoarthritis. Knee osteoarthritis (OA) is a disabling disease that carries a substantial burden to society and to the individual affected.
Detailed Description
Restoring quadriceps muscle strength following anterior cruciate ligament reconstruction (ACLR) may help prevent the post-traumatic knee osteoarthritis that affects over 50% of knees 10-20 years after surgical reconstruction. However, a fundamental gap exists in current understanding of how to maximize muscle strength following ACLR, as current rehabilitation fails to restore symmetrical quadriceps strength. The investigators pilot work shows that when patients return to activity, quadriceps strength is ~70% of the uninjured side, which is far below the recommended 90%. Further, these data suggest that embedding high-intensity neuromuscular electrical stimulation (NMES) and eccentric exercise into standard of care ACL rehabilitation leads to higher quadriceps strength when compared with standard of care alone. However, the true efficacy of these interventions is unknown, as controlled trials with adequate sample sizes are currently lacking. The absence of this information serves as the driving force and focus of the proposed trial. Therefore, the investigators propose a double-blind randomized controlled trial where ACLR patients will be randomized to 1 of 2 arms. Study arms will include: 1) 8 weeks of NMES+8 weeks of eccentric exercise; 2) 8 weeks of NMES placebo+8 weeks of eccentric placebo. All study arms will receive standard of care ACL rehabilitation in addition to the study interventions. The investigators hypothesize that subjects receiving NMES+eccentric exercise (Arm 1) will realize greater improvements in strength and biomechanical function at 6 months following ACLR than patients in the placebo study arm. Further, the investigators anticipate that patients in the NMES+eccentric exercise arm (Arm 1) will best eliminate negative changes in cartilage health at 18 months following ACLR. This study is innovative, because it employs interventions that directly target the primary mechanisms that result in strength loss following ACLR and will also evaluate whether improving muscle strength can minimize early changes in cartilage health, which may be indicative of future osteoarthritis. The proposed research is significant because it will identify evidence-based treatment approaches that can successfully counteract the muscle weakness which plagues ACLR patients for years after injury and contributes to the onset of post-traumatic osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury
Keywords
Knee, ACL, Reconstruction, Rehabilitation, Eccentric Exercise, Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NMES+ECC
Arm Type
Experimental
Arm Description
Neuromuscular electrical stimulation (NMES) and Eccentric Exercise (ECC). Patients randomized to the NMES+ECC group will first receive NMES for 2x/week for 8 weeks, beginning at the first post-operative visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive eccentric exercise 2x/week for an additional 8 weeks. For NMES, patients will have electrical stimulation delivered to their quadriceps. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For eccentric exercise, patients will train for 4 sets of 10 repetitions. This group will also receive standard of care ACL rehabilitation alongside the study interventions.
Arm Title
NMES placebo + ECC placebo
Arm Type
Placebo Comparator
Arm Description
Neuromuscular electrical stimulation (NMES) placebo + Eccentric Exercise (ECC)placebo arm. Patients randomized to the NMES placebo + ECC placebo group will first receive NMES placebo for 2x/week for 8 weeks, beginning at the first post-operative physical therapy visit. Beginning at 9 weeks after anterior cruciate ligament reconstruction (ACLR) patients will begin to receive an eccentric exercise placebo 2x/week for 8 weeks. For the NMES placebo, patients will have NMES placebo delivered to their quadriceps 2x/week for 8 weeks beginning at the first post-operative visit. Fifteen isometric actions lasting 10 seconds each will be elicited during each session. For the eccentric exercise placebo, patients will begin to receive eccentric exercise two times per week for 8 weeks. Patients will train for 4 sets of 10 repetitions.
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimulation (NMES)
Other Intervention Name(s)
Electrical Stimulation, Estim
Intervention Description
The electrical stimulator will deliver a 2500 Hz alternating current, modulated at 75 bursts/s, with a ramp-up time of 2-seconds, followed by a 50-second rest period. Stimulus intensity set to generate a maximum voluntary isometric contraction (MVIC) of at least 40& of the contralateral MVIC.
Intervention Type
Other
Intervention Name(s)
Eccentric Exercise (ECC)
Intervention Description
4 sets of 10 repetitions of an eccentric leg press exercise performed at 70-90% of the 1 repetition maximum
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimulation (NMES) placebo
Intervention Description
The electrical stimulator will deliver a 2500 Hz alternating current, modulated at 75 bursts/s, with a ramp-up time of 2-seconds, followed by a 50-second rest period. Stimulus intensity set to generate a maximum voluntary isometric contraction (MVIC) of 10-20% of the contralateral MVIC.
Intervention Type
Other
Intervention Name(s)
Eccentric Exercise (ECC) placebo
Intervention Description
4 sets of 10 repetitions of an eccentric leg press exercise performed at 10-20% of the 1 repetition maximum
Primary Outcome Measure Information:
Title
Change from baseline to 6 months isokinetic quadriceps strength index
Description
concentric isokinetic muscle strength at 60 degrees per second
Time Frame
Pre-surgery (baseline), 6 months (6 months post-ACL reconstruction)
Title
Change from baseline to 18 months isokinetic quadriceps strength index
Description
concentric isokinetic muscle strength at 60 degrees per second
Time Frame
Pre-surgery (baseline), 18 months (18 months post-ACL reconstruction)
Secondary Outcome Measure Information:
Title
T1 rho relaxation time symmetry scores for knee joint cartilage
Description
[T1rho value from MRI for right knee (msec)/T1rho value for left knee (msec)] x 100
Time Frame
18 months post-ACL reconstruction
Title
T2 relaxation time symmetry scores for knee joint cartilage
Description
[T2 value from MRI for right knee (msec)/T2 value for left knee (msec)] x 100
Time Frame
18 months post-ACL reconstruction
Title
Knee Flexion Angle at 6 months
Description
Peak knee flexion angle recorded during a single-legged hop (units: degrees)
Time Frame
6 months post-ACL reconstruction
Title
Knee Flexion Angle at 18 months
Description
Peak knee flexion angle recorded during a single-legged hop (units: degrees)
Time Frame
18 months post-ACL reconstruction
Title
Knee Flexion Moment at 6 months
Description
Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)
Time Frame
6 months post-ACL reconstruction
Title
Knee Flexion Moment at 18 months
Description
Peak knee flexion moment recorded during a single-legged hop (units: Nm/kg)
Time Frame
18 months post-ACL reconstruction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acute, complete ACL rupture ACL reconstruction with autograft Scheduled to undergo ACLR at U of Michigan Willingness to participate in testing and follow-up as outlined Exclusion Criteria: Previous surgery to either knee Bony fracture accompanying ACL injury Patients who experienced a knee dislocation Female participants who are pregnant or planning pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riann M Palmieri-Smith, PhD
Phone
734-615-3154
Email
riannp@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Tropiano
Phone
734-615-5373
Email
etropian@umich.edu
Facility Information:
Facility Name
MedSport
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riann Palmieri-Smith, PhD
Phone
734-615-3154
Email
riannp@umich.edu
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riann M Palmieri-Smith, PhD
Phone
734-615-3154
Email
riannp@umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32939539
Citation
Rodriguez K, Garcia SA, Spino C, Lepley LK, Pang Y, Wojtys E, Bedi A, Angelini M, Ruffino B, Bolley T, Block C, Kellum J, Swartout A, Palmieri-Smith RM. Michigan Initiative for Anterior Cruciate Ligament Rehabilitation (MiACLR): A Protocol for a Randomized Clinical Trial. Phys Ther. 2020 Dec 7;100(12):2154-2164. doi: 10.1093/ptj/pzaa169.
Results Reference
derived

Learn more about this trial

MiACLR: Michigan Initiative for Anterior Cruciate Ligament Rehabilitation

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