Anterior Cruciate Ligament Injuries Clinical Trial
— ENTACLROfficial title:
Effectiveness of Neuromuscular Training on Lower Extremity in Post-operative Anterior Cruciate Ligament Reconstruction
| Verified date | April 2020 |
| Source | Riphah International University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of the study was to determine the effectiveness of neuromuscular physical
Therapy as compared to strength training after ACL reconstruction in terms of pain, function,
quality of life, strength and power of participants after ACL reconstruction.
It was a Randomized clinical trial conducted Kanaan Physiotherapy & Spine Clinic, Lahore.
Seventy-six patients were selected by purposive sampling technique and equally divided into
one of two treatment groups either neuromuscular training or strength training with use of
sealed envelope randomization. The study was completed in 6 months. Patients were assessed
using the Cincinnati Knee Score for function, Numeric Pain Rating Scale (NPRS) for pain,
SF-36 for quality of life, and Hop test (single leg, Triple, crossover and 6-meter hop) for
power and strength.Patients received the treatment 3 times per week for six consecutive
weeks.
| Status | Completed |
| Enrollment | 84 |
| Est. completion date | December 1, 2019 |
| Est. primary completion date | December 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Patients between ages 20-40 years having unilateral ACL injury. - Patients of both genders. - Underwent surgical reconstruction of the ACL. - Participants after two months of ACL unilateral reconstruction. - Participants who attended physical therapy sessions for first two months to reduce swelling and to gain ROM post operatively. - Patients willing to participate in the study Exclusion Criteria: - History of previous complicated knee surgery - Non-operative treatment; partial ACL tear; bilateral ACL injury; associated ligament pathology that required surgical treatment at the time of the index surgery; Outerbridge grade III or IV chondral injury; revision ACL reconstruction - Participation in other studies that may conflict with participation in this study. - Complex associated injuries (multiple ligamentous injury, extensive cartilage/meniscus injury) - Recently re-injured in 1 month. Complications such as cancer, inflammatory arthritis, disorders of autoimmune nature (Rheumatoid arthritis), anticoagulant conditions, neurodegenerative diseases (Parkinson's Disease, Motor neuron disease), organic referred pain, pregnancy, and disability compensation. |
| Country | Name | City | State |
|---|---|---|---|
| Pakistan | Riphah International University | Islamabad | Federal |
| Lead Sponsor | Collaborator |
|---|---|
| Riphah International University |
Pakistan,
Mather RC 3rd, Hettrich CM, Dunn WR, Cole BJ, Bach BR Jr, Huston LJ, Reinke EK, Spindler KP. Cost-Effectiveness Analysis of Early Reconstruction Versus Rehabilitation and Delayed Reconstruction for Anterior Cruciate Ligament Tears. Am J Sports Med. 2014 Jul;42(7):1583-91. doi: 10.1177/0363546514530866. Epub 2014 May 6. — View Citation
Murray JJ, Renier CM, Ahern JJ, Elliott BA. Neuromuscular Training Availability and Efficacy in Preventing Anterior Cruciate Ligament Injury in High School Sports: A Retrospective Cohort Study. Clin J Sport Med. 2017 Nov;27(6):524-529. doi: 10.1097/JSM.0000000000000398. — View Citation
Porter MD, Shadbolt B. "Anatomic" single-bundle anterior cruciate ligament reconstruction reduces both anterior translation and internal rotation during the pivot shift. Am J Sports Med. 2014 Dec;42(12):2948-54. doi: 10.1177/0363546514549938. Epub 2014 Sep 19. — View Citation
Risberg MA, Holm I, Myklebust G, Engebretsen L. Neuromuscular training versus strength training during first 6 months after anterior cruciate ligament reconstruction: a randomized clinical trial. Phys Ther. 2007 Jun;87(6):737-50. Epub 2007 Apr 18. — View Citation
Shim JK, Choi HS, Shin JH. Effects of neuromuscular training on knee joint stability after anterior cruciate ligament reconstruction. J Phys Ther Sci. 2015 Dec;27(12):3613-7. doi: 10.1589/jpts.27.3613. Epub 2015 Dec 28. — View Citation
Struewer J, Frangen TM, Ishaque B, Bliemel C, Efe T, Ruchholtz S, Ziring E. Knee function and prevalence of osteoarthritis after isolated anterior cruciate ligament reconstruction using bone-patellar tendon-bone graft: long-term follow-up. Int Orthop. 2012 Jan;36(1):171-7. doi: 10.1007/s00264-011-1345-0. Epub 2011 Sep 7. — View Citation
Uçar M, Koca I, Eroglu M, Eroglu S, Sarp U, Arik HO, Yetisgin A. Evaluation of open and closed kinetic chain exercises in rehabilitation following anterior cruciate ligament reconstruction. J Phys Ther Sci. 2014 Dec;26(12):1875-8. doi: 10.1589/jpts.26.1875. Epub 2014 Dec 25. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | NPRS | To rate pain of patients and 1 to 3 considered as mild, 4 to 7 considered as Moderate and 8 to 10 considered as severe pain | 4 months | |
| Primary | SF-36 | Quality of Life | 4 months | |
| Secondary | Cincinnati Knee score | The Cincinnati Knee Rating System is one of the most commonly used instruments to measure the results of anterior cruciate ligament reconstruction,The total score is calculated as the sum of all questions responses, with 100 representing the best/excellent knee function, and 0 representing the worst/poor knee function. | 4 months | |
| Secondary | Hop Tests | A series of hop tests are routinely used in the assessment for return to sports post-injury, be it an ankle sprain, stress fracture or anterior cruciate ligament reconstruction | 4 months |
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