Neuromuscular Training on Lower Extremity in Post-operative Anterior Cruciate Ligament Reconstruction

NCT ID: NCT04355078

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2019-12-01

Brief Summary

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.

Detailed Description

The knee joint problems and injuries has been rising as a result of more number of patients getting injuries in various daily livings e.g traffic and industrial accidents Ligamentous injuries are one of the commonest injuries of knee among which occurrence of Anterior cruciate ligament(ACL) injuries are of considerable importance The ACL is actually made up of many bundles of connective tissue and it has course from femur to tibia as shown in picture. The ACL is main ligament which prevents tibia to go outwards and excessive loads. When knee is in straight position ACL has 32mm length and 7-12mm width.ACL has 2 parts anteromedial bundle and posterolateral bundle. During flex position AMB goes into lengthened position and PLB goes into shorten position. It is made up of collagen fibres and its framework has proteins, glycoproteins, elastic systems, and glycoseminoglycans. Because of its elastic property it undergoes into many stresses. And it has nerve supply of tibial nerve and it has arterial supply of middle genicular artery. The Occurrence of ACL injures mostly reported among paediatric and adolescent population as compared to adult population. This factor which raises the contribution of adults to participate in sports are younger age high performance training, awareness of injury and use of better modalities. Short term complications of ACL that include loss of function, pain and reconstructive surgery period of about 24 to 36 weeks required for return to function. Reconstructive surgeries include autogenous or allogeneic graft reconstruction Many studies showed that after reconstructive surgery patients return to sports. Most (82%) patients are able to return to sport activity according to a meta-analysis results; however preinjury levels of performance are attained in only 43-65.7% of cases. Long-term complication of ACL injuries that significantly include osteoarthritis that develop later in life. One of the studies show that 50% of diagnosed patients of meniscus or ACL tear might develop osteoarthritis (OA) in the affected knee in about 10-20 years after surgery and the prevalence and severity of OA has not been shown to reduce by reconstructive surgery. Newer surgical approaches and techniques seems to reduce risk of developing osteoarthritis later in life but still questionable.

Conditions

Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neuromuscular Training

The rehabilitation program starts two months after surgery, 45 minutes daily session, 3 times a week for 6 weeks. The involved leg is used if nothing else is stated that includes Walking on a treadmill, Squatting exercises, Single leg stance exercise Balance reach leg and arm exercises, Lunge exercises: anterior, lateral and posterior, Step-up and step down exercises, Single leg standing on balance mat, appropriate knee and hip position, Backwards and sideways walking for 5 steps on each side 1, 1 leg and 2 leg Wobble board Exercise and progress after every two weeks

Group Type: EXPERIMENTAL

Neuromuscular Training

Intervention Type: OTHER

Muscular and neural training by complex exercises

Strength Training

The rehabilitation program starts two months after surgery, 45 minutes daily session, 3 times a week for 6 weeks that includes straight leg raising exercises, Supine position-isometric quadriceps contraction, Supine position-knee flexion and extension ROM exercises, the heel in contact with the bench during the ROM, Prone position-straight leg raising exercises, Prone position-knee flexion \& Extension ROM exercises, Stationary biking-before reaching 100 degrees of flexion(Progression: stair climbing and strength exercises), Standing-full weight-bearing, controlled balance double-limb support during parallel and diagonal stance, controlled knee extension, emphasis on full knee extension in weight-bearing position 3 10 reps Standing heel rising exercises both legs and one leg, 1 leg and 2 leg Wobble board Exercise, Step Up and down low height, Squatting exercises without bars/weight, Hamstrings, hip adductor and abductor strengthening exercises and progress after every two weeks

Group Type: EXPERIMENTAL

Strength Training

Intervention Type: OTHER

Strength Training

Interventions

Neuromuscular Training

Muscular and neural training by complex exercises

Intervention Type: OTHER

Strength Training

Strength Training

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Faheem Afzal, Phd*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Riphah International University

Islamabad, Federal, Pakistan

Countries

Pakistan

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 25540486 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 25239931 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 21898038 (View on PubMed)

Other Identifiers

REC/00587 Kehkshan Khalid

Identifier Type: -

Identifier Source: org_study_id