The University of Toledo
Toledo, Ohio, 43606, United States
NCT Number: NCT05738200
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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Notify Me18 year–35 year
All sexes
Interventional
Not applicable
Toledo, Ohio, 43606, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline, 4 weeks
Hamstrings
Time frame: Baseline, 4 weeks
Hamstrings
Time frame: Baseline, 4 weeks
Hamstrings
Time frame: Baseline, 4 weeks
Hamstrings
Time frame: Baseline, 4 weeks
Hamstrings
Time frame: Baseline, 4 weeks
Hamstrings
Time frame: Baseline, 4 weeks
Hop for distance
Time frame: Baseline, 4 weeks
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
Time frame: Baseline, 4 weeks
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
Time frame: Baseline, 4 weeks
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
Time frame: Baseline, 4 weeks
Transcranial magnetic stimulation (TMS) derived outcome in semitendinosus
Time frame: Baseline, 4 weeks
Current knee pain questionnaire (range: 0 [no pain] to 10 [high pain])
Time frame: Baseline, 4 weeks
Fear of pain-related movement and reinjury questionnaire (range: 11 [low fear] to 44 [high fear])
Time frame: Baseline, 4 weeks
Psychological readiness questionnaire (range: 0 [low readiness] to 100 [high readiness])
Time frame: Baseline, 4 weeks
Subjective knee function questionnaire (range: 0 [low function] to 100 [high function])
Time frame: Baseline, 4 weeks
Subjective knee function questionnaire (range: 0 [low function] to 100 [high function])
Time frame: Baseline, 4 weeks
Global health questionnaire (range: 0 [low global health] to 100 [high global health])
Time frame: Baseline, 4 weeks
Subjective activity level questionnaire (range: 0 [low activity] to 10 [high activity])
Time frame: Baseline, 4 weeks
Subjective activity level (higher values = higher activity level)
Time frame: 4 weeks
Objectively monitored physical activity
Time frame: 4 weeks
Subjective perception of change in knee function following intervention (range: -7 [worse knee function] to 7 [better knee function])
Time frame: 4 weeks (intervention group only)
Interest/enjoyment and value/usefulness subscale questionnaires (range: 7 [no interest/enjoyment or value/usefulness] to 49 [high interest/enjoyment or value/usefulness])
Time frame: 4 weeks (intervention group only)
Subjective perception of effort/difficulty during exercise questionnaire (range: 6 [light effort] to 20 [high effort]), completed during each intervention session
Time frame: 4 weeks (intervention group only)
Average pain or discomfort questionnaire (range: 0 [no pain/discomfort] to 10 [high pain/discomfort]), completed during each intervention session
University of Toledo
Other
Use of Nordic Hamstring Exercise to Improve Hamstrings Function in Patients After ACL Reconstruction
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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