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Completed

NCT Number: NCT04355078

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Islamabad, Federal, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neuromuscular Training

Other

Muscular and neural training by complex exercises

Strength training

Other

Strength Training

Primary outcomes

  1. NPRS

    Time frame: 4 months

    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

  2. SF-36

    Time frame: 4 months

    Quality of Life

Secondary outcomes

  1. Cincinnati Knee score

    Time frame: 4 months

    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.

  2. Hop Tests

    Time frame: 4 months

    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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Acronym: ENTACLR

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 21, 2020
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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