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

April 20, 2020 updated by: Riphah International University

Effectiveness of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 44000
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Other: Neuromuscular Training
Muscular and neural training by complex exercises
EXPERIMENTAL: 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
Other: Strength Training
Strength Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months
SF-36
Time Frame: 4 months
Quality of Life
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Muhammad Faheem Afzal, Phd*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

February 28, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (ACTUAL)

April 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/00587 Kehkshan Khalid

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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