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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Riann Palmieri-Smith, University of Michigan
ClinicalTrials.gov Identifier:
NCT01555567
First received: March 6, 2012
Last updated: May 13, 2015
Last verified: May 2015
Results First Received: April 26, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Anterior Cruciate Ligament Injury
Interventions: Device: Electrical Stimulation
Other: Eccentric Exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Neuromuscular Electrical Stimulation

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

Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week

Standard of Care This group will undergo standard ACL rehabilitation
Eccentric Exercise

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.

Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week

Combination of NMES and Eccentric Exercise

Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES 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.

Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week

Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week


Participant Flow for 2 periods

Period 1:   12 Week
    Neuromuscular Electrical Stimulation     Standard of Care     Eccentric Exercise     Combination of NMES and Eccentric Exercise  
STARTED     12     13     9     9  
COMPLETED     11     12     8     9  
NOT COMPLETED     1     1     1     0  

Period 2:   Return to Activity
    Neuromuscular Electrical Stimulation     Standard of Care     Eccentric Exercise     Combination of NMES and Eccentric Exercise  
STARTED     11     12     8     9  
COMPLETED     10     10     8     8  
NOT COMPLETED     1     2     0     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Neuromuscular Electrical Stimulation

Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.

Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week

Standard of Care This group will undergo standard ACL rehabilitation
Eccentric Exercise

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.

Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week

Combination of NMES and Eccentric Exercise

Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES 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.

Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week

Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week

Total Total of all reporting groups

Baseline Measures
    Neuromuscular Electrical Stimulation     Standard of Care     Eccentric Exercise     Combination of NMES and Eccentric Exercise     Total  
Number of Participants  
[units: participants]
  10     10     8     8     36  
Age  
[units: years]
Mean (Standard Deviation)
  21.8  (4.4)     18.3  (3.7)     23.2  (5.4)     23.2  (6.3)     21.6  (4.9)  
Gender  
[units: participants]
         
Female     2     5     3     3     13  
Male     8     5     5     5     23  
Region of Enrollment  
[units: participants]
         
United States     10     10     8     8     36  
Height  
[units: meter]
Mean (Standard Deviation)
  1.76  (.1)     1.73  (.1)     1.75  (.1)     1.45  (.6)     1.67  (.22)  
Mass  
[units: kg]
Mean (Standard Deviation)
  81.65  (22.6)     75.5  (24.1)     77.7  (10.4)     77.8  (16.5)     78.2  (18.4)  
Quadriceps Strength  
[units: Nm/kg]
Mean (Standard Deviation)
  2.6  (.6)     2.6  (.6)     2.8  (1.1)     2.7  (.8)     2.67  (.78)  
Central Activation Ratio (CAR) [1]
[units: ratio]
Mean (Standard Deviation)
  97.4  (3)     94.9  (5.3)     95.9  (4.5)     95.7  (3.5)     95.9  (4.1)  
[1] CAR = maximal voluntary isometric contraction force / maximal voluntary isometric contractions force + stimulated force



  Outcome Measures
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1.  Primary:   Quadriceps Strength   [ Time Frame: Time of return to activity (~6 months following surgery) ]

2.  Secondary:   Central Activation Ratio   [ Time Frame: Time of return to activity (~6 months following surgery) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Riann Palmieri-Smith
Organization: University of Michigan
phone: 7346153154
e-mail: riannp@umich.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Riann Palmieri-Smith, University of Michigan
ClinicalTrials.gov Identifier: NCT01555567     History of Changes
Other Study ID Numbers: ACLNMES
1K08AR053152-01A2 ( US NIH Grant/Contract Award Number )
Study First Received: March 6, 2012
Results First Received: April 26, 2015
Last Updated: May 13, 2015
Health Authority: United States: Institutional Review Board