Trial Outcomes & Findings for Electrical Stimulation and Eccentric Exercise for Anterior Cruciate Ligament (ACL) Injury (NCT NCT01555567)
NCT ID: NCT01555567
Last Updated: 2015-06-08
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
Time of return to activity (~6 months following surgery)
Results posted on
2015-06-08
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
12 Week
STARTED
|
12
|
13
|
9
|
9
|
|
12 Week
COMPLETED
|
11
|
12
|
8
|
9
|
|
12 Week
NOT COMPLETED
|
1
|
1
|
1
|
0
|
|
Return to Activity
STARTED
|
11
|
12
|
8
|
9
|
|
Return to Activity
COMPLETED
|
10
|
10
|
8
|
8
|
|
Return to Activity
NOT COMPLETED
|
1
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Electrical Stimulation and Eccentric Exercise for Anterior Cruciate Ligament (ACL) Injury
Baseline characteristics by cohort
| Measure |
Neuromuscular Electrical Stimulation
n=10 Participants
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
n=10 Participants
This group will undergo standard ACL rehabilitation
|
Eccentric Exercise
n=8 Participants
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
n=8 Participants
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
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
21.8 years
STANDARD_DEVIATION 4.4 • n=93 Participants
|
18.3 years
STANDARD_DEVIATION 3.7 • n=4 Participants
|
23.2 years
STANDARD_DEVIATION 5.4 • n=27 Participants
|
23.2 years
STANDARD_DEVIATION 6.3 • n=483 Participants
|
21.6 years
STANDARD_DEVIATION 4.9 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
8 participants
n=27 Participants
|
8 participants
n=483 Participants
|
36 participants
n=36 Participants
|
|
Height
|
1.76 meter
STANDARD_DEVIATION .1 • n=93 Participants
|
1.73 meter
STANDARD_DEVIATION .1 • n=4 Participants
|
1.75 meter
STANDARD_DEVIATION .1 • n=27 Participants
|
1.45 meter
STANDARD_DEVIATION .6 • n=483 Participants
|
1.67 meter
STANDARD_DEVIATION .22 • n=36 Participants
|
|
Mass
|
81.65 kg
STANDARD_DEVIATION 22.6 • n=93 Participants
|
75.5 kg
STANDARD_DEVIATION 24.1 • n=4 Participants
|
77.7 kg
STANDARD_DEVIATION 10.4 • n=27 Participants
|
77.8 kg
STANDARD_DEVIATION 16.5 • n=483 Participants
|
78.2 kg
STANDARD_DEVIATION 18.4 • n=36 Participants
|
|
Quadriceps Strength
|
2.6 Nm/kg
STANDARD_DEVIATION .6 • n=93 Participants
|
2.6 Nm/kg
STANDARD_DEVIATION .6 • n=4 Participants
|
2.8 Nm/kg
STANDARD_DEVIATION 1.1 • n=27 Participants
|
2.7 Nm/kg
STANDARD_DEVIATION .8 • n=483 Participants
|
2.67 Nm/kg
STANDARD_DEVIATION .78 • n=36 Participants
|
|
Central Activation Ratio (CAR)
|
97.4 ratio
STANDARD_DEVIATION 3 • n=93 Participants
|
94.9 ratio
STANDARD_DEVIATION 5.3 • n=4 Participants
|
95.9 ratio
STANDARD_DEVIATION 4.5 • n=27 Participants
|
95.7 ratio
STANDARD_DEVIATION 3.5 • n=483 Participants
|
95.9 ratio
STANDARD_DEVIATION 4.1 • n=36 Participants
|
PRIMARY outcome
Timeframe: Time of return to activity (~6 months following surgery)Outcome measures
| Measure |
Neuromuscular Electrical Stimulation
n=10 Participants
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
n=10 Participants
This group will undergo standard ACL rehabilitation
|
Eccentric Exercise
n=8 Participants
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
n=8 Participants
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
|
|---|---|---|---|---|
|
Quadriceps Strength
|
2.1 Nm/kg
Standard Deviation 0.6
|
2.1 Nm/kg
Standard Deviation 0.6
|
2.8 Nm/kg
Standard Deviation 0.9
|
2.9 Nm/kg
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Time of return to activity (~6 months following surgery)CAR = maximal voluntary isometric contractions force / maximal voluntary isometric contractions force + stimulated force
Outcome measures
| Measure |
Neuromuscular Electrical Stimulation
n=10 Participants
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
n=10 Participants
This group will undergo standard ACL rehabilitation
|
Eccentric Exercise
n=8 Participants
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
n=8 Participants
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
|
|---|---|---|---|---|
|
Central Activation Ratio
|
91.8 ratio
Standard Deviation 4.6
|
91.8 ratio
Standard Deviation 9
|
98.1 ratio
Standard Deviation 1.2
|
97.6 ratio
Standard Deviation 2.8
|
Adverse Events
Neuromuscular Electrical Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Eccentric Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combination of NMES and Eccentric Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place