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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01555567
Recruitment Status : Completed
First Posted : March 15, 2012
Results First Posted : May 14, 2015
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Riann Palmieri-Smith, University of Michigan

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Anterior Cruciate Ligament Injury
Interventions Device: Electrical Stimulation
Other: Eccentric Exercise
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neuromuscular Electrical Stimulation Standard of Care Eccentric Exercise Combination of NMES and Eccentric Exercise
Hide Arm/Group Description

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

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.

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

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

Period Title: 12 Week
Started 12 13 9 9
Completed 11 12 8 9
Not Completed 1 1 1 0
Period Title: Return to Activity
Started 11 12 8 9
Completed 10 10 8 8
Not Completed 1 2 0 1
Arm/Group Title Neuromuscular Electrical Stimulation Standard of Care Eccentric Exercise Combination of NMES and Eccentric Exercise Total
Hide Arm/Group Description

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

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.

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

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 of all reporting groups
Overall Number of Baseline Participants 10 10 8 8 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 8 participants 8 participants 36 participants
21.8  (4.4) 18.3  (3.7) 23.2  (5.4) 23.2  (6.3) 21.6  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 8 participants 8 participants 36 participants
Female
2
  20.0%
5
  50.0%
3
  37.5%
3
  37.5%
13
  36.1%
Male
8
  80.0%
5
  50.0%
5
  62.5%
5
  62.5%
23
  63.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 8 participants 8 participants 36 participants
10 10 8 8 36
Height  
Mean (Standard Deviation)
Unit of measure:  Meter
Number Analyzed 10 participants 10 participants 8 participants 8 participants 36 participants
1.76  (.1) 1.73  (.1) 1.75  (.1) 1.45  (.6) 1.67  (.22)
Mass  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 10 participants 10 participants 8 participants 8 participants 36 participants
81.65  (22.6) 75.5  (24.1) 77.7  (10.4) 77.8  (16.5) 78.2  (18.4)
Quadriceps Strength  
Mean (Standard Deviation)
Unit of measure:  Nm/kg
Number Analyzed 10 participants 10 participants 8 participants 8 participants 36 participants
2.6  (.6) 2.6  (.6) 2.8  (1.1) 2.7  (.8) 2.67  (.78)
Central Activation Ratio (CAR)   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 10 participants 10 participants 8 participants 8 participants 36 participants
97.4  (3) 94.9  (5.3) 95.9  (4.5) 95.7  (3.5) 95.9  (4.1)
[1]
Measure Description: CAR = maximal voluntary isometric contraction force / maximal voluntary isometric contractions force + stimulated force
1.Primary Outcome
Title Quadriceps Strength
Hide Description [Not Specified]
Time Frame Time of return to activity (~6 months following surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neuromuscular Electrical Stimulation Standard of Care Eccentric Exercise Combination of NMES and Eccentric Exercise
Hide Arm/Group Description:

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

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.

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

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

Overall Number of Participants Analyzed 10 10 8 8
Mean (Standard Deviation)
Unit of Measure: Nm/kg
2.1  (0.6) 2.1  (0.6) 2.8  (0.9) 2.9  (0.6)
2.Secondary Outcome
Title Central Activation Ratio
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neuromuscular Electrical Stimulation Standard of Care Eccentric Exercise Combination of NMES and Eccentric Exercise
Hide Arm/Group Description:

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

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.

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

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

Overall Number of Participants Analyzed 10 10 8 8
Mean (Standard Deviation)
Unit of Measure: ratio
91.8  (4.6) 91.8  (9) 98.1  (1.2) 97.6  (2.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neuromuscular Electrical Stimulation Standard of Care Eccentric Exercise Combination of NMES and Eccentric Exercise
Hide Arm/Group Description

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

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.

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

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

All-Cause Mortality
Neuromuscular Electrical Stimulation Standard of Care Eccentric Exercise Combination of NMES and Eccentric Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Neuromuscular Electrical Stimulation Standard of Care Eccentric Exercise Combination of NMES and Eccentric Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Neuromuscular Electrical Stimulation Standard of Care Eccentric Exercise Combination of NMES and Eccentric Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Riann Palmieri-Smith
Organization: University of Michigan
Phone: 7346153154
EMail: riannp@umich.edu
Layout table for additonal information
Responsible Party: Riann Palmieri-Smith, University of Michigan
ClinicalTrials.gov Identifier: NCT01555567    
Other Study ID Numbers: ACLNMES
1K08AR053152-01A2 ( U.S. NIH Grant/Contract )
First Submitted: March 6, 2012
First Posted: March 15, 2012
Results First Submitted: April 26, 2015
Results First Posted: May 14, 2015
Last Update Posted: June 8, 2015