NCT03473821

Brief Summary

Anterior cruciate ligament injury is a common issue in sports involving cutting and jumping. Treatment may include surgical intervention followed by physical therapy, or no surgical intervention with the main treatment being physical therapy. Despite meeting physical therapist requirements for return to sport, many athletes do not return to sport. This discrepancy in the physical requirements for returning to physical activity and actually returning to the same physical activity level leads to the question of whether current rehabilitation treatments may be improved upon. One potential method is by integrating mental training into physical rehabilitation. By using mental training and increasing the meaning and relevance of rehabilitation, a person may be preparing more effectively for return to the pace and intensity common during physical activity. In this study, the investigators aim to create and evaluate a model of training which incorporates physical activity-related movement and mental training in order to more effectively prepare people for return to physical activity after anterior cruciate ligament injury. This will be measured by examining functional hop measures, as well as patient-reported outcomes.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

February 28, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

March 25, 2018

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 24, 2024

Status Verified

April 1, 2024

Enrollment Period

5.2 years

First QC Date

February 28, 2018

Last Update Submit

April 23, 2024

Conditions

Keywords

ACL InjuryReturn to SportMental TrainingDynamic Motor ImageryAnterior Cruciate LigamentKnee Injury

Outcome Measures

Primary Outcomes (2)

  • Side Hop

    Change in hop performance on the injured leg from baseline to 12 weeks, expressed in number of hops completed

    12 weeks

  • Anterior Cruciate Ligament Return to Sport After Injury Scale

    12 question self-reported outcome scale measuring readiness to return to sport. Scale ranges from 0-10 for each question. Scores summed from 0 (worst) - 100 (best).

    12 months

Secondary Outcomes (11)

  • Test Battery to Assess Postural Orientation During Functional Tasks

    12 weeks

  • Hop Test Battery

    12 weeks

  • Knee Injury and Osteoarthritis Outcome Score

    12 weeks; 12 month follow-up

  • Rehabilitation Outcome Satisfaction

    12 months; 12 month follow-up

  • Perceived Stress Scale

    12 weeks; 12 month follow-up

  • +6 more secondary outcomes

Study Arms (2)

Neuromuscular Training

NO INTERVENTION

Participants in this group will undergo rehabilitation for ACL injury consisting of neuromuscular training according to care-as-usual treatment common to physical therapy professionals.

MOTIFS

EXPERIMENTAL

Participants in this group will receive an intervention that has been developed according to our new training model, known as MOTor Imagery to Facilitate Sensorimotor re-learning (MOTIFS). In this intervention, patients will receive a neuromuscular training rehabilitation program with integrated dynamic motor imagery.

Behavioral: MOTIFS

Interventions

MOTIFSBEHAVIORAL

o MOTor Imagery to Facilitate Sensorimotor re-learning (MOTIFS) is an individualized and physical activity-specific integrated model that includes aspects of both neuromuscular training, as used in rehabilitation practices, and Dynamic Motor Imagery (DMI). DMI is a form of mental training in which the participant images him-/herself performing a task from a first-person perspective in order to maximize functional equivalence to the task in question. This includes dynamic, physical movement, as well as mental imaging. The intervention provides a framework for designing individualized, physical activity-specific rehabilitation exercises for knee-injured people.

Also known as: Neuromuscular Training Plus Mental Training, Train the Brain Model
MOTIFS

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women
  • Over the age of 16
  • Traumatic knee injury with or without surgical intervention, and involving one or more knee structures
  • Currently undergoing physical therapist-supervised rehabilitation and have reached the stage in rehabilitation which includes single-leg hop training (i.e. able to complete a side hop and a single-leg hop for distance)
  • Active before the injury in recreational or competitive physical activity, with a goal of returning to physical activity

You may not qualify if:

  • Any degenerative knee disorder, or other disease or disorder overriding the knee injury (e.g. spine disorder, neurological disease)
  • Do not understand the languages of interest (Swedish, Danish, Norwegian), or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Lund, Skåne County, 221 00, Sweden

Location

Related Publications (23)

  • Ageberg E, Thomee R, Neeter C, Silbernagel KG, Roos EM. Muscle strength and functional performance in patients with anterior cruciate ligament injury treated with training and surgical reconstruction or training only: a two to five-year followup. Arthritis Rheum. 2008 Dec 15;59(12):1773-9. doi: 10.1002/art.24066.

    PMID: 19035430BACKGROUND
  • Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.

    PMID: 20660401BACKGROUND
  • Ardern CL, Taylor NF, Feller JA, Webster KE. Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med. 2014 Nov;48(21):1543-52. doi: 10.1136/bjsports-2013-093398. Epub 2014 Aug 25.

    PMID: 25157180BACKGROUND
  • Ardern CL, Webster KE, Taylor NF, Feller JA. Return to sport following anterior cruciate ligament reconstruction surgery: a systematic review and meta-analysis of the state of play. Br J Sports Med. 2011 Jun;45(7):596-606. doi: 10.1136/bjsm.2010.076364. Epub 2011 Mar 11.

    PMID: 21398310BACKGROUND
  • Risberg MA, Grindem H, Oiestad BE. We Need to Implement Current Evidence in Early Rehabilitation Programs to Improve Long-Term Outcome After Anterior Cruciate Ligament Injury. J Orthop Sports Phys Ther. 2016 Sep;46(9):710-3. doi: 10.2519/jospt.2016.0608.

    PMID: 27581178BACKGROUND
  • Guillot A, Moschberger K, Collet C. Coupling movement with imagery as a new perspective for motor imagery practice. Behav Brain Funct. 2013 Feb 20;9:8. doi: 10.1186/1744-9081-9-8.

    PMID: 23425312BACKGROUND
  • Smith D, et al. It's All in the Mind: PETTLEP-Based Imagery and Sports Performance. J Appl Sport Psychol 2007;19:80-92.

    BACKGROUND
  • Cumming J, et al. Introducing the revised applied model of deliberate imagery use for sport, dance, exercise, and rehabilitation. Movement & Sport Sciences 2013;1:69-81.

    BACKGROUND
  • Grooms DR, Page SJ, Onate JA. Brain Activation for Knee Movement Measured Days Before Second Anterior Cruciate Ligament Injury: Neuroimaging in Musculoskeletal Medicine. J Athl Train. 2015 Oct;50(10):1005-10. doi: 10.4085/1062-6050-50.10.02. Epub 2015 Sep 29.

    PMID: 26509775BACKGROUND
  • Holmes PS, Collins DJ. The PETTLEP approach to motor imagery: A functional equivalence model for sport psychologists. Journal of Applied Sport Psychology 2001;13(1):60-83. doi: 10.1080/104132001753155958

    BACKGROUND
  • Webster KE, Feller JA, Lambros C. Development and preliminary validation of a scale to measure the psychological impact of returning to sport following anterior cruciate ligament reconstruction surgery. Phys Ther Sport. 2008 Feb;9(1):9-15. doi: 10.1016/j.ptsp.2007.09.003. Epub 2007 Nov 5.

    PMID: 19083699BACKGROUND
  • Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.

    PMID: 4028566BACKGROUND
  • Gustavsson A, Neeter C, Thomee P, Silbernagel KG, Augustsson J, Thomee R, Karlsson J. A test battery for evaluating hop performance in patients with an ACL injury and patients who have undergone ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2006 Aug;14(8):778-88. doi: 10.1007/s00167-006-0045-6. Epub 2006 Mar 9.

    PMID: 16525796BACKGROUND
  • Nae J, Creaby MW, Cronstrom A, Ageberg E. Measurement properties of visual rating of postural orientation errors of the lower extremity - A systematic review and meta-analysis. Phys Ther Sport. 2017 Sep;27:52-64. doi: 10.1016/j.ptsp.2017.04.003. Epub 2017 Apr 18.

    PMID: 28647205BACKGROUND
  • Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.

    PMID: 9699158BACKGROUND
  • Howie JG, Heaney DJ, Maxwell M, Walker JJ. A comparison of a Patient Enablement Instrument (PEI) against two established satisfaction scales as an outcome measure of primary care consultations. Fam Pract. 1998 Apr;15(2):165-71. doi: 10.1093/fampra/15.2.165.

    PMID: 9613486BACKGROUND
  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND
  • Kendzierski D, DeCarlo KJ. Physical Activity Enjoyment Scale: Two Validation Studies. Journal of Sport and Exercise Psychology 1991;13(1):50-64. doi: 10.1123/jsep.13.1.50

    BACKGROUND
  • Ardern CL, Osterberg A, Sonesson S, Gauffin H, Webster KE, Kvist J. Satisfaction With Knee Function After Primary Anterior Cruciate Ligament Reconstruction Is Associated With Self-Efficacy, Quality of Life, and Returning to the Preinjury Physical Activity. Arthroscopy. 2016 Aug;32(8):1631-1638.e3. doi: 10.1016/j.arthro.2016.01.035. Epub 2016 Mar 24.

    PMID: 27020461BACKGROUND
  • Cederstrom N, Graner S, Nilsson G, Ageberg E. Effect of motor imagery on enjoyment in knee-injury prevention and rehabilitation training: A randomized crossover study. J Sci Med Sport. 2021 Mar;24(3):258-263. doi: 10.1016/j.jsams.2020.09.004. Epub 2020 Sep 10.

    PMID: 32958377BACKGROUND
  • Cederstrom N, Graner S, Nilsson G, Dahan R, Ageberg E. Motor Imagery to Facilitate Sensorimotor Re-Learning (MOTIFS) after traumatic knee injury: study protocol for an adaptive randomized controlled trial. Trials. 2021 Oct 21;22(1):729. doi: 10.1186/s13063-021-05713-8.

    PMID: 34674738BACKGROUND
  • Cederstrom N, Nilsson G, Dahan R, Graner S, Ageberg E. Using an integrated motor imagery and physical training intervention after knee injury: an interim analysis of the MOTIFS randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Oct 2;10(4):e002064. doi: 10.1136/bmjsem-2024-002064. eCollection 2024.

  • Cederstrom N, Ageberg E, Graner S. Lived experiences of patients undergoing treatment for traumatic knee injury using integrated psychological training (MOTIFS) in the context of care-as-usual training: a phenomenological interview study. BMJ Open Sport Exerc Med. 2022 Nov 22;8(4):e001409. doi: 10.1136/bmjsem-2022-001409. eCollection 2022.

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesKnee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Eva Ageberg, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will be blinded, but due to the nature of the study, neither the primary investigator, participant, nor the care providers can be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 single assessor-blinded adaptive randomized controlled trial, which will conform to the CONSORT statement
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 22, 2018

Study Start

March 25, 2018

Primary Completion

June 6, 2023

Study Completion

June 1, 2024

Last Updated

April 24, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

A Study Protocol was published in Trials (DOI: 10.1186/s13063-021-05713-8) October 2021. Upon completion of data collection and analysis, data may be available from the author upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Upon completion of data collection (estimated completion January 2022). Data availability in accordance with data management guidelines at Lund University (e.g. available up to 15 years after publication/finalized project)
Access Criteria
Data may be shared upon reasonable request by contacting the corresponding author: Niklas Cederström niklas.cederstrom@med.lu.se
More information

Available IPD Datasets

Statistical Analysis Plan Access

Locations