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Anterior cruciate ligament (ACL) injuries constitute a significant portion of major knee joint injuries sustained by young, active individuals, and significantly increase risk for long-term disability. Yet the recommended solution to restore joint stability following injury--ACL reconstruction (ACLR)--does not prevent post-traumatic knee osteoarthritis (PTOA). Post-traumatic quadriceps (dys)function is a hallmark characteristic following ACLR, reported to accelerate the onset of PTOA after ACL injury, making the recovery of muscle function a primary concern to clinicians. However, hamstrings muscle function is drastically underrepresented relative to the quadriceps in the context of recovery from ACLR, which impedes the ability to develop targeted treatment approaches. Persistent hamstrings weakness is widely reported in patients who undergo ACLR with a hamstring tendon (HT) autograft, which increases ACL strain, and may contribute to higher graft failure rates in this population. To effectively treat muscular impairments, underlying neuromuscular adaptations known to occur in response to ACLR must be targeted. Eccentric exercise is uniquely suited to enhance neuromuscular function. The Nordic hamstring exercise (NHE) is a specific form of eccentric exercise that is clinically relevant and easy to implement, but has not been explored as an intervention for hamstrings neuromuscular dysfunction in patients who undergo ACLR with HT. To establish an evidence-based treatment model, the investigators will use a single-blind, randomized controlled clinical trial to establish the feasibility and efficacy of a 4-week NHE protocol in patients who undergo ACLR with HT. Separate factorial ANOVAs will be used to assess the effects of group (NHE, control) and time (baseline, 4 weeks) on selected outcomes. Effect sizes will be calculated for within- and between-group comparisons. The investigators expect to observe improvements in hamstrings neuromuscular function following the NHE protocol, and that those improvements will be greater than the control group. Additionally, the investigators expect the protocol to be feasible in terms of intervention adherence and patient retention. This study will identify specific barriers to the implementation of NHE in patients who undergo ACLR with HT, and will provide support for the application of an easy to implement clinical intervention able to address a complex neurophysiological problem.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nordic Hamstring Exercise | Experimental | A 4-week (10 session), progressive, Nordic Hamstring Exercise (NHE) protocol will be used for this study. |
|
| Control | No Intervention | Patients randomized to the control group will be instructed to avoid any changes to their normal routine (e.g., physical activity level, strength training, etc.). An investigator not involved in data collection will communicate with patients in the control group on a weekly basis to ensure they have not changed their physical activity level and do not have any questions. Patients randomized to the control group will participate in a minimum of 2 study visits at baseline and 4 weeks. These individuals will have the option to open enroll in the intervention group at the completion of their original 4-week study period. Those who choose to enroll in the intervention group at this time will return for 11 additional visits to complete the NHE protocol (visits 3-12) and final assessment (visit 13) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nordic Hamstring Exercise | Other | A 4-week (10 session), progressive, NHE protocol will be used for this study. Immediately following the completion of study visit 1, patients will be informed about the nature of the NHE protocol. Those available and willing to participate will be randomized to an intervention group (NHE, control). Patients randomized to NHE will receive formal instruction about how to correctly perform the exercise, and will be asked to perform several repetitions to familiarize themselves with the exercise and verify proper technique. At this time, patients will be dismissed from study visit 1, and return visits 2-11 will be scheduled to complete the NHE protocol. Patients will return for a final study visit (12) to record post-intervention measurements within 7 days of completing the NHE protocol. A minimum of 48 hours will be used to separate study visits. To accurately assess patients' ability to perform the NHE, all exercise will be performed on a NordBord Hamstring Testing System. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak eccentric torque | Hamstrings | Baseline, 4 weeks |
| Change in peak isometric torque | Hamstrings | Baseline, 4 weeks |
| Change in peak isokinetic torque | Hamstrings | Baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in rate of torque development | Hamstrings | Baseline, 4 weeks |
| Change in torque coefficient of variation | Hamstrings | Baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual analog scale | Current knee pain questionnaire (range: 0 [no pain] to 10 [high pain]) | Baseline, 4 weeks |
| Change in Tampa Scale of Kinesiophobia 11-item | Fear of pain-related movement and reinjury questionnaire (range: 11 [low fear] to 44 [high fear]) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grant Norte, PhD, ATC | The University of Toledo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Toledo | Toledo | Ohio | 43606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40181441 | Derived | Norte GE, Glaviano NR, Sherman DA, Rush JL, Murray AM. Four-week Nordic hamstring exercise intervention for individuals with ACL reconstruction via hamstrings tendon autograft: feasibility of a pilot randomized controlled trial. Pilot Feasibility Stud. 2025 Apr 3;11(1):37. doi: 10.1186/s40814-025-01624-6. |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| D018908 | Muscle Weakness |
| D020879 | Neuromuscular Manifestations |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D009135 | Muscular Diseases |
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|
| Change in central activation ratio | Hamstrings | Baseline, 4 weeks |
| Change in single leg hop | Hop for distance | Baseline, 4 weeks |
| Change in active motor threshold | Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus | Baseline, 4 weeks |
| Change in cortical silent period | Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus | Baseline, 4 weeks |
| Change in short-interval cortical inhibition | Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus | Baseline, 4 weeks |
| Change in intracortical facilitation | Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus | Baseline, 4 weeks |
| Baseline, 4 weeks |
| Change in ACL Return to Sport after Injury | Psychological readiness questionnaire (range: 0 [low readiness] to 100 [high readiness]) | Baseline, 4 weeks |
| Change in International Knee Documentation Committee Subjective Knee Evaluation | Subjective knee function questionnaire (range: 0 [low function] to 100 [high function]) | Baseline, 4 weeks |
| Change in Knee Injury and Osteoarthritis Outcome Score | Subjective knee function questionnaire (range: 0 [low function] to 100 [high function]) | Baseline, 4 weeks |
| Veterans RAND 12-Item Health Survey | Global health questionnaire (range: 0 [low global health] to 100 [high global health]) | Baseline, 4 weeks |
| Change in Tegner Activity Scale | Subjective activity level questionnaire (range: 0 [low activity] to 10 [high activity]) | Baseline, 4 weeks |
| Change in International Physical Activity Questionnaire | Subjective activity level (higher values = higher activity level) | Baseline, 4 weeks |
| Time spent in moderate-to-vigorous physical activity | Objectively monitored physical activity | 4 weeks |
| Global Rating of Change | Subjective perception of change in knee function following intervention (range: -7 [worse knee function] to 7 [better knee function]) | 4 weeks |
| Intrinsic Motivation Inventory | Interest/enjoyment and value/usefulness subscale questionnaires (range: 7 [no interest/enjoyment or value/usefulness] to 49 [high interest/enjoyment or value/usefulness]) | 4 weeks (intervention group only) |
| Average rating of perceived exertion | Subjective perception of effort/difficulty during exercise questionnaire (range: 6 [light effort] to 20 [high effort]), completed during each intervention session | 4 weeks (intervention group only) |
| Average visual analog scale | Average pain or discomfort questionnaire (range: 0 [no pain/discomfort] to 10 [high pain/discomfort]), completed during each intervention session | 4 weeks (intervention group only) |
| D009140 |
| Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |