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

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Neuromuscular Training
Strength Training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring Anterior cruciate ligament, Neuromuscular training,Strength

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Neuromuscular Training

Strength Training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
SF-36
Quality of Life

Secondary Outcome Measures

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.
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

Full Information

First Posted
February 28, 2020
Last Updated
April 20, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04355078
Brief Title
Neuromuscular Training on Lower Extremity in Post-operative Anterior Cruciate Ligament Reconstruction
Acronym
ENTACLR
Official Title
Effectiveness of Neuromuscular Training on Lower Extremity in Post-operative Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
Anterior cruciate ligament, Neuromuscular training,Strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular Training
Arm Type
Experimental
Arm Description
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
Arm Title
Strength Training
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Neuromuscular Training
Intervention Description
Muscular and neural training by complex exercises
Intervention Type
Other
Intervention Name(s)
Strength Training
Intervention Description
Strength Training
Primary Outcome Measure Information:
Title
NPRS
Description
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
Time Frame
4 months
Title
SF-36
Description
Quality of Life
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Cincinnati Knee score
Description
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.
Time Frame
4 months
Title
Hop Tests
Description
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
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Faheem Afzal, Phd*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26834316
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.
Results Reference
background
PubMed Identifier
25540486
Citation
Ucar 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.
Results Reference
background
PubMed Identifier
24801663
Citation
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.
Results Reference
background
PubMed Identifier
17442840
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. doi: 10.2522/ptj.20060041. Epub 2007 Apr 18.
Results Reference
background
PubMed Identifier
25239931
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.
Results Reference
background
PubMed Identifier
27755010
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.
Results Reference
background
PubMed Identifier
21898038
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.
Results Reference
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Neuromuscular Training on Lower Extremity in Post-operative Anterior Cruciate Ligament Reconstruction

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