Functional Resistance Training to Improve Knee Function After ACL Reconstruction
Primary Purpose
Anterior Cruciate Ligament Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Functional Resistance Training with Brace
Control
Functional Resistance Training with Elastic Band
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring ACL, Quadriceps, Muscle, Resistance Training
Eligibility Criteria
Inclusion Criteria:
- aged 14-40 years
- suffered an acute, complete ACL rupture
- willingness to participate in testing and follow-up as outlined in the protocol
- English-speaking
Exclusion Criteria:
- inability to provide written informed consent
- female subjects who are pregnant or are planning to become pregnant
- previous ACL injury
- previous surgery to either knee
- bony fracture accompanying ACL injury
- patients who experienced a knee dislocation;
- patients who are contraindicated for transcranial magnetic stimulation (e.g., metal implants in head, unexplained recurrent headaches, history of seizures, epileptogenic drugs, active psychiatric illness, etc.).
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Functional Resistance Training with a Brace
Functional Resistance Training with Elastic Band
Control
Arm Description
Participants will receive functional resistance training via a knee brace while walking on a treadmill 2-3 times a week for about 8 weeks.
Participants will receive functional resistance training via an elastic band attached at the ankle while walking on a treadmill 2-3 times a week for about 8 weeks.
Participants will while on a treadmill without an applied resistance 2-3 times a week for about 8 weeks.
Outcomes
Primary Outcome Measures
Quadriceps Muscle Strength
Isometric quadriceps strength was measured with the knee at 60 degrees using an isokinetic dynamometer prior to the intervention and immediately after the intervention. Post-test minus pre-test change scores were calculated.
Secondary Outcome Measures
Quadriceps Voluntary Activation
Quadriceps voluntary activation was measured using the burst superimposition technique and calculated using the central activation ratio (CAR). The CAR formula is calculated using the peak torque generated immediately prior to the delivery of the stimulus (or the maximum voluntary isometric contraction, MVIC) being divided by the peak torque generated as a result of the electrical stimulus (MVIC plus superimposed burst) and then multiplied by 100. Equation is: MVIC/(MVIC + superimposed burst) × 100. A CAR of 100 represents complete volitional quadriceps activation.
Voluntary activation was quantified immediately after the intervenapproximately 9-10 weeks after the int from baseline to the end of intervention will be assessed and compared between groups.
Knee Flexion Angle Symmetry
The knee flexion angle (measured in degrees) during the stance phase was gathered for both limbs using three dimension motion capture and recorded while subjects walked overground. A knee flexion angle symmetry score was computed using the following formula: ensemble average of knee flexion angle of ACL limb minus the ensemble average of knee flexion angle of the non-ACL limb. The mean difference between pre-intervention and post-intervention (post minus pre) knee flexion symmetry scores were calculated for each group. Higher values suggest greater increases in knee flexion angle symmetry from pre-intervention to post-intervention.
Knee Moment Symmetry
The sagittal plane knee moment (units Nm) during the stance phase was gathered for both limbs using three dimensional motion capture and recorded while subjects walk overground. A symmetry score was computed using the following formula: ensemble average of the knee moment of the ACL limb (Nm) - ensemble average of the knee moment of the non-ACL limb (Nm). The mean difference between pre-intervention and post-intervention knee moment symmetry scores (post minus pre) were calculated for each group. Higher values represent the greater increases in knee moment symmetry from pre-intervention to post-intervention.
Full Information
NCT ID
NCT03282565
First Posted
September 12, 2017
Last Updated
January 13, 2022
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT03282565
Brief Title
Functional Resistance Training to Improve Knee Function After ACL Reconstruction
Official Title
Functional Resistance Training During Gait: A Novel Intervention to Improve Knee Knee Function After ACL Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 17, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine if thigh muscle weakness and the lack of muscle activation that accompanies ACL injury and reconstruction can be improved with functional resistance training.
Detailed Description
Profound quadriceps weakness is ubiquitous after anterior cruciate ligament (ACL) reconstruction, and current rehabilitation approaches are not successful in optimizing quadriceps strength and knee function even years after the surgery. We hypothesize that suboptimal strength and functional outcomes after ACL surgery are due to the lack of task-specific exercise elements during strength training. This application seeks to assess whether progressive functional resistance training during gait will significantly improve quadriceps function, neural excitability, and knee mechanics during gait. The proposed studies will not only lay the foundation for a novel training paradigm, but will also improve our understanding of the mechanisms mediating neuromuscular and biomechanical changes after functional resistance training.
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, Quadriceps, Muscle, Resistance Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional Resistance Training with a Brace
Arm Type
Experimental
Arm Description
Participants will receive functional resistance training via a knee brace while walking on a treadmill 2-3 times a week for about 8 weeks.
Arm Title
Functional Resistance Training with Elastic Band
Arm Type
Experimental
Arm Description
Participants will receive functional resistance training via an elastic band attached at the ankle while walking on a treadmill 2-3 times a week for about 8 weeks.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Participants will while on a treadmill without an applied resistance 2-3 times a week for about 8 weeks.
Intervention Type
Other
Intervention Name(s)
Functional Resistance Training with Brace
Intervention Description
A brace will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
A brace will be strapped to the leg and will not apply resistance across the knee while subjects walk on a treadmill.
Intervention Type
Other
Intervention Name(s)
Functional Resistance Training with Elastic Band
Intervention Description
An elastic band will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill.
Primary Outcome Measure Information:
Title
Quadriceps Muscle Strength
Description
Isometric quadriceps strength was measured with the knee at 60 degrees using an isokinetic dynamometer prior to the intervention and immediately after the intervention. Post-test minus pre-test change scores were calculated.
Time Frame
Pre-test measurements were taken at ~9-10 weeks after ACL reconstruction and Post-test measurements were taken at ~18-20 weeks after ACL reconstruction.
Secondary Outcome Measure Information:
Title
Quadriceps Voluntary Activation
Description
Quadriceps voluntary activation was measured using the burst superimposition technique and calculated using the central activation ratio (CAR). The CAR formula is calculated using the peak torque generated immediately prior to the delivery of the stimulus (or the maximum voluntary isometric contraction, MVIC) being divided by the peak torque generated as a result of the electrical stimulus (MVIC plus superimposed burst) and then multiplied by 100. Equation is: MVIC/(MVIC + superimposed burst) × 100. A CAR of 100 represents complete volitional quadriceps activation.
Voluntary activation was quantified immediately after the intervenapproximately 9-10 weeks after the int from baseline to the end of intervention will be assessed and compared between groups.
Time Frame
Immediately after the intervention or approximately 18-20 weeks after ACL reconstruction
Title
Knee Flexion Angle Symmetry
Description
The knee flexion angle (measured in degrees) during the stance phase was gathered for both limbs using three dimension motion capture and recorded while subjects walked overground. A knee flexion angle symmetry score was computed using the following formula: ensemble average of knee flexion angle of ACL limb minus the ensemble average of knee flexion angle of the non-ACL limb. The mean difference between pre-intervention and post-intervention (post minus pre) knee flexion symmetry scores were calculated for each group. Higher values suggest greater increases in knee flexion angle symmetry from pre-intervention to post-intervention.
Time Frame
Pre-intervention values were recorded at ~9-10 weeks after ACL reconstruction and before the start of the intervention. Post-intervention values were recorded after the 8-week intervention (~18-20 weeks after ACL reconstruction)
Title
Knee Moment Symmetry
Description
The sagittal plane knee moment (units Nm) during the stance phase was gathered for both limbs using three dimensional motion capture and recorded while subjects walk overground. A symmetry score was computed using the following formula: ensemble average of the knee moment of the ACL limb (Nm) - ensemble average of the knee moment of the non-ACL limb (Nm). The mean difference between pre-intervention and post-intervention knee moment symmetry scores (post minus pre) were calculated for each group. Higher values represent the greater increases in knee moment symmetry from pre-intervention to post-intervention.
Time Frame
Pre-intervention scores were recorded prior to the start of the intervention and approximately 9-10 weeks after ACL reconstruction. Post-intervention scores were recorded after the 8 week intervention or approximately 18-20 weeks after ACL reconstruction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 14-40 years
suffered an acute, complete ACL rupture
willingness to participate in testing and follow-up as outlined in the protocol
English-speaking
Exclusion Criteria:
inability to provide written informed consent
female subjects who are pregnant or are planning to become pregnant
previous ACL injury
previous surgery to either knee
bony fracture accompanying ACL injury
patients who experienced a knee dislocation;
patients who are contraindicated for transcranial magnetic stimulation (e.g., metal implants in head, unexplained recurrent headaches, history of seizures, epileptogenic drugs, active psychiatric illness, etc.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riann Palmieri-Smith, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chandramouli Krishnan, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Functional Resistance Training to Improve Knee Function After ACL Reconstruction
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