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Functional Resistance Training to Improve Knee Function After ACL Reconstruction

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ClinicalTrials.gov Identifier: NCT03282565
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Riann Palmieri-Smith, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Other: Functional Resistance Training Other: Control Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Resistance Training During Gait: A Novel Intervention to Improve Knee Knee Function After ACL Reconstruction
Actual Study Start Date : March 17, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Functional Resistance Training
Participants will receive functional resistance training while walking on a treadmill 2-3 times a week for about 8 weeks.
Other: Functional Resistance Training
A brace/cuff/exercise band will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill.

Sham Comparator: Control
Participants will while on a treadmill without an applied resistance 2-3 times a week for about 8 weeks.
Other: Control
A brace/cuff/exercise band will be strapped to the leg and will not apply resistance across the knee while subjects walk on a treadmill.




Primary Outcome Measures :
  1. Changes in quadriceps muscle strength [ Time Frame: Approximately 8 weeks after the start of intervention ]
    Quadriceps strength will be measured using an isokinetic dynamometer. Improvements in quadriceps strength from baseline to the end of intervention will be assessed and compared between groups.


Secondary Outcome Measures :
  1. Changes in quadriceps voluntary activation [ Time Frame: Approximately 8 weeks after the start of intervention ]
    Voluntary activation will be measured using an electrical superimposition technique. Improvements in voluntary activation from baseline to the end of intervention will be assessed and compared between groups.

  2. Knee flexion angle symmetry [ Time Frame: Approximately 8 weeks after the start of intervention ]
    The knee flexion angle will be gathered for both limbs using 3D motion capture and recorded while subjects walk and climb stairs. A symmetry score will be computed using the following formula: ((knee flexion angle of involved limb/knee flexion angle of the uninvolved limb)*100). Improvements in knee flexion angle symmetry from baseline to the end of intervention will be assessed and compared between groups.

  3. Knee flexion moment symmetry [ Time Frame: Approximately 8 weeks after the start of intervention ]
    The knee flexion moment will be gathered for both limbs using 3D motion capture and recorded while subjects walk and climb stairs. A symmetry score will be computed using the following formula: ((knee flexion moment of involved limb/knee flexion moment of the uninvolved limb)*100).Improvements in knee flexion moment symmetry from baseline to the end of intervention will be assessed and compared between groups.



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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282565


Contacts
Contact: Riann M Palmieri-Smith, PhD 734-615-3154 riannp@umich.edu
Contact: Chandramouli Krishnan, PhD 734-936-4031 mouli@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Riann M Palmieri-Smith, PhD    734-615-3154    riannp@umich.edu   
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Riann Palmieri-Smith, PhD University of Michigan
Principal Investigator: Chandramouli Krishnan, PhD University of Michigan

Responsible Party: Riann Palmieri-Smith, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03282565     History of Changes
Other Study ID Numbers: HUM00133860
R21HD092614 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Riann Palmieri-Smith, University of Michigan:
ACL
Quadriceps
Muscle
Resistance Training

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries