NCT04355078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

February 28, 2020

Last Update Submit

April 20, 2020

Conditions

Keywords

Anterior cruciate ligament, Neuromuscular training,Strength

Outcome Measures

Primary Outcomes (2)

  • 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

  • SF-36

    Quality of Life

    4 months

Secondary Outcomes (2)

  • Cincinnati Knee score

    4 months

  • Hop Tests

    4 months

Study Arms (2)

Neuromuscular Training

EXPERIMENTAL

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

Strength Training

EXPERIMENTAL

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

Interventions

Muscular and neural training by complex exercises

Neuromuscular Training

Strength Training

Strength Training

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (7)

  • 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.

    PMID: 26834316BACKGROUND
  • 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.

    PMID: 25540486BACKGROUND
  • 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.

    PMID: 24801663BACKGROUND
  • 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.

    PMID: 17442840BACKGROUND
  • 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.

    PMID: 25239931BACKGROUND
  • 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.

    PMID: 27755010BACKGROUND
  • 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.

    PMID: 21898038BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Muhammad Faheem Afzal, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2020

First Posted

April 21, 2020

Study Start

July 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations