Trial Outcomes & Findings for Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes (NCT NCT03190889)

NCT ID: NCT03190889

Last Updated: 2026-03-11

Results Overview

Subjects recruited for this investigation will be recovering from primary ACL injury. Participants will be monitored for injury history from time of enrollment in study. Report of any additional ACL injury whether contralateral leg or involved leg will be counted as a second ACL injury.

Recruitment status

COMPLETED

Study phase

Target enrollment

150 participants

Primary outcome timeframe

12-48 months

Results posted on

2026-03-11

Participant Flow

Subjects over 1 hour drive (50 miles) away from the treatment facility were limited to STAN or HOME group randomization.

Participant milestones

Participant milestones
Measure	STAN Patients in the STAN group will participate in twelve sessions of supervised physical therapy over a six week period. Patients will participate in agility and plyometric drills, and continue strength exercises from the previous treatment phase. The clinic program will be performed in conjunction with a home running program. Patients in this group will not receive feedback from the therapist regarding movement quality during activities.	HOME HOME Program is distinguished by patients participating in a home only intervention that consists of running and strengthening exercises performed twice a week for six weeks. No plyometric or agility drills are performed in this study arm. This represents the minimal intervention to prepare for a return to sports. No neuromuscular training or movement training beyond the sagittal plane will be performed. HOME: At home rehabilitation following ACL reconstructive surgery as described in the HOME arm.	TNMT Patients who are enrolled in the TNMT group will participate in 12 sessions of supervised outpatient physical therapy over a six week period. The TNMT protocol is distinguished by performance of exercises designed to enhance core and hip strength, performance of neuromuscular training exercise that are designed to correct movement flaws associated with second ACL injury25, providing verbal and visual feedback and performance of single leg drills on both legs. TNMT: Standard of care, clinical rehabilitation following ACL reconstructive surgery with the addition of specified targeted neuromuscular training as described in the TNMT arm.
Overall Study STARTED	51	50	49
Overall Study COMPLETED	38	33	42
Overall Study NOT COMPLETED	13	17	7

Reasons for withdrawal

Reasons for withdrawal
Measure	STAN Patients in the STAN group will participate in twelve sessions of supervised physical therapy over a six week period. Patients will participate in agility and plyometric drills, and continue strength exercises from the previous treatment phase. The clinic program will be performed in conjunction with a home running program. Patients in this group will not receive feedback from the therapist regarding movement quality during activities.	HOME HOME Program is distinguished by patients participating in a home only intervention that consists of running and strengthening exercises performed twice a week for six weeks. No plyometric or agility drills are performed in this study arm. This represents the minimal intervention to prepare for a return to sports. No neuromuscular training or movement training beyond the sagittal plane will be performed. HOME: At home rehabilitation following ACL reconstructive surgery as described in the HOME arm.	TNMT Patients who are enrolled in the TNMT group will participate in 12 sessions of supervised outpatient physical therapy over a six week period. The TNMT protocol is distinguished by performance of exercises designed to enhance core and hip strength, performance of neuromuscular training exercise that are designed to correct movement flaws associated with second ACL injury25, providing verbal and visual feedback and performance of single leg drills on both legs. TNMT: Standard of care, clinical rehabilitation following ACL reconstructive surgery with the addition of specified targeted neuromuscular training as described in the TNMT arm.
Overall Study Lost to Follow-up	7	7	3
Overall Study Withdrawal by Subject	1	1	2
Overall Study Did not complete protocol	4	9	0
Overall Study COVID-19	1	0	2

Baseline Characteristics

Neuromuscular Intervention Targeted to Mechanisms of ACL Load in Female Athletes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STAN n=49 Participants Patients in the STAN group will participate in twelve sessions of supervised physical therapy over a six week period. Patients will participate in agility and plyometric drills, and continue strength exercises from the previous treatment phase. The clinic program will be performed in conjunction with a home running program. Patients in this group will not receive feedback from the therapist regarding movement quality during activities.	HOME n=48 Participants HOME Program is distinguished by patients participating in a home only intervention that consists of running and strengthening exercises performed twice a week for six weeks. No plyometric or agility drills are performed in this study arm. This represents the minimal intervention to prepare for a return to sports. No neuromuscular training or movement training beyond the sagittal plane will be performed. HOME: At home rehabilitation following ACL reconstructive surgery as described in the HOME arm.	TNMT n=47 Participants Patients who are enrolled in the TNMT group will participate in 12 sessions of supervised outpatient physical therapy over a six week period. The TNMT protocol is distinguished by performance of exercises designed to enhance core and hip strength, performance of neuromuscular training exercise that are designed to correct movement flaws associated with second ACL injury25, providing verbal and visual feedback and performance of single leg drills on both legs. TNMT: Standard of care, clinical rehabilitation following ACL reconstructive surgery with the addition of specified targeted neuromuscular training as described in the TNMT arm.	Total n=144 Participants Total of all reporting groups
Age, Categorical <=18 years	36 Participants n=9 Participants	31 Participants n=9 Participants	35 Participants n=18 Participants	102 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=9 Participants	17 Participants n=9 Participants	12 Participants n=18 Participants	42 Participants n=15 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants
Age, Continuous	16.90 years STANDARD_DEVIATION 3.03 • n=9 Participants	18.19 years STANDARD_DEVIATION 4.11 • n=9 Participants	16.98 years STANDARD_DEVIATION 3.19 • n=18 Participants	17.35 years STANDARD_DEVIATION 3.50 • n=15 Participants
Sex: Female, Male Female	26 Participants n=9 Participants	26 Participants n=9 Participants	32 Participants n=18 Participants	84 Participants n=15 Participants
Sex: Female, Male Male	23 Participants n=9 Participants	22 Participants n=9 Participants	15 Participants n=18 Participants	60 Participants n=15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=9 Participants	0 Participants n=9 Participants	1 Participants n=18 Participants	3 Participants n=15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=9 Participants	45 Participants n=9 Participants	46 Participants n=18 Participants	137 Participants n=15 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants	3 Participants n=9 Participants	0 Participants n=18 Participants	4 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	1 Participants n=9 Participants	0 Participants n=18 Participants	1 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	1 Participants n=9 Participants	1 Participants n=18 Participants	2 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	8 Participants n=9 Participants	7 Participants n=9 Participants	6 Participants n=18 Participants	21 Participants n=15 Participants
Race (NIH/OMB) White	37 Participants n=9 Participants	35 Participants n=9 Participants	38 Participants n=18 Participants	110 Participants n=15 Participants
Race (NIH/OMB) More than one race	4 Participants n=9 Participants	2 Participants n=9 Participants	2 Participants n=18 Participants	8 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	2 Participants n=9 Participants	0 Participants n=18 Participants	2 Participants n=15 Participants
Region of Enrollment United States	49 participants n=9 Participants	48 participants n=9 Participants	47 participants n=18 Participants	144 participants n=15 Participants
Height	170 centimeters STANDARD_DEVIATION 11 • n=9 Participants	172 centimeters STANDARD_DEVIATION 8 • n=9 Participants	169 centimeters STANDARD_DEVIATION 7 • n=18 Participants	170 centimeters STANDARD_DEVIATION 9 • n=15 Participants
Mass	72.36 kilograms STANDARD_DEVIATION 15.66 • n=9 Participants	68.93 kilograms STANDARD_DEVIATION 14.52 • n=9 Participants	70.27 kilograms STANDARD_DEVIATION 18.20 • n=18 Participants	70.52 kilograms STANDARD_DEVIATION 16.13 • n=15 Participants

PRIMARY outcome

Timeframe: 12-48 months

Population: Only subjects who completed both pre and post-testing assessments and completed at least one year of subsequent injury tracking were included.

Outcome measures

Outcome measures
Measure	STAN n=27 Participants Patients in the STAN group will participate in twelve sessions of supervised physical therapy over a six week period. Patients will participate in agility and plyometric drills, and continue strength exercises from the previous treatment phase. The clinic program will be performed in conjunction with a home running program. Patients in this group will not receive feedback from the therapist regarding movement quality during activities.	HOME n=28 Participants HOME Program is distinguished by patients participating in a home only intervention that consists of running and strengthening exercises performed twice a week for six weeks. No plyometric or agility drills are performed in this study arm. This represents the minimal intervention to prepare for a return to sports. No neuromuscular training or movement training beyond the sagittal plane will be performed. HOME: At home rehabilitation following ACL reconstructive surgery as described in the HOME arm.	TNMT n=32 Participants Patients who are enrolled in the TNMT group will participate in 12 sessions of supervised outpatient physical therapy over a six week period. The TNMT protocol is distinguished by performance of exercises designed to enhance core and hip strength, performance of neuromuscular training exercise that are designed to correct movement flaws associated with second ACL injury25, providing verbal and visual feedback and performance of single leg drills on both legs. TNMT: Standard of care, clinical rehabilitation following ACL reconstructive surgery with the addition of specified targeted neuromuscular training as described in the TNMT arm.
Number of Participants With Second ACL Injury	3 Participants	7 Participants	5 Participants

SECONDARY outcome

Timeframe: Change after 6 weeks of interventional protocol

Joint moments at the knee will be recorded from study participants as they perform athletic tasks. Frontal plane knee moments have previously been associated with ACL injury risk and will be used to assess the proposed treatment groups.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change after 6 weeks of interventional protocol

Joint excursion and angles at the knee will be recorded from study participants as they perform athletic tasks. Frontal plane excursion and angle has been associated with increased frontal plane moments that are associated with increased relative risk of ACL injury.

Outcome measures

Outcome data not reported

Adverse Events

STAN

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HOME

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TNMT

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

Nathaniel A. Bates

The Ohio State University Wexner Medical Center

Phone: 614-293-9013

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place