title: Efficacy of early controlled motion of the ankle compared with no motion after non-operative treatment of an acute Achilles tendon rupture: study protocol for a randomized controlled trial.
abstract: Early controlled ankle motion is widely used in the non-operative treatment of acute Achilles tendon rupture, though its safety and efficacy have never been investigated in a randomized setup. The objectives of this study are to investigate if early controlled motion of the ankle affects functional and patient-reported outcomes.
  
  
  
  The study is performed as a blinded, randomized, controlled trial with patients allocated in a 1:1 ratio to one of two parallel groups. Patients aged from 18 to 70 years are eligible for inclusion. The intervention group performs early controlled motion of the ankle in weeks 3-8 after rupture. The control group is immobilized. In total, 130 patients will be included from one big orthopedic center over a period of 2½ years. The primary outcome is the patient-reported Achilles tendon Total Rupture Score evaluated at 12 months post-injury. Secondary outcome measures are the heel-rise work test, Achilles tendon elongation, and the rate of re-rupture. The primary analysis will be conducted as intention-to-treat analyses.
  
  
  
  This trial is the first to investigate the safety and efficacy of early controlled motion in the treatment of acute Achilles tendon rupture in a randomized setup. The study uses the patient-reported outcome measure, the Achilles tendon Total Rupture Score, as the primary endpoint, as it is believed to be the best surrogate measure for the tendon's actual capability to function in everyday life.
  
  
  
  ClinicalTrials.gov: NCT02015364 . Registered on 13 December 2013.
authors.affiliation: Department of Orthopedic Surgery, Clinical Orthopedic Research Hvidovre, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, Hvidovre, 2650, Denmark. kbarfod@dadlnet.dk.
authors.forename: Kristoffer Weisskirchner
authors.initials: KW
authors.lastname: Barfod
authors.affiliation: Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, Hvidovre, 2650, Denmark.
authors.forename: Maria Swennergren
authors.initials: MS
authors.lastname: Hansen
authors.affiliation: Sports Orthopedic Research Center - Copenhagen (SORC-C), Arthroscopic Center, Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Holmich
authors.affiliation: Department of Orthopedic Surgery, Clinical Orthopedic Research Hvidovre, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, Hvidovre, 2650, Denmark.
authors.forename: Anders
authors.initials: A
authors.lastname: Troelsen
authors.affiliation: Physical Medicine and Rehabilitation Research - Copenhagen (PMR-C), Department of Physiotherapy and Occupational Therapy, Copenhagen University Hospital Hvidovre, Kettegård Allé 30, Hvidovre, 2650, Denmark.
authors.forename: Morten Tange
authors.initials: MT
authors.lastname: Kristensen
mesh_terms: D000125:Achilles Tendon / Q000293:injuries / Q000503:physiopathology*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000843:Ankle Joint / Q000503:physiopathology*; D001696:Biomechanical Phenomena; D002985:Clinical Protocols; D003718:Denmark; D005081:Exercise Therapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D016059:Range of Motion, Articular; D020127:Recovery of Function; D012008:Recurrence; D012107:Research Design; D013708:Tendon Injuries / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D016474:Weight-Bearing; D055815:Young Adult
keywords: Achilles tendon; Achilles tendon rupture; Dynamic mobilization; Early controlled motion; Non-operative treatment