We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Motor Imagery to Facilitate Sensorimotor Relearning After ACL Injury (MOTIFS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03473821
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : April 29, 2022
Sponsor:
Information provided by (Responsible Party):
Lund University

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.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Behavioral: MOTIFS Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 single assessor-blinded adaptive randomized controlled trial, which will conform to the CONSORT statement
Masking: Single (Outcomes Assessor)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Motor Imagery to Facilitate Sensorimotor Relearning (MOTIFS) After ACL Injury: A Randomized Controlled Trial
Actual Study Start Date : March 25, 2018
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
No Intervention: Neuromuscular Training
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.
Experimental: MOTIFS
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
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.
Other Names:
  • Neuromuscular Training Plus Mental Training
  • Train the Brain Model




Primary Outcome Measures :
  1. Side Hop [ Time Frame: 12 weeks ]
    Change in hop performance on the injured leg from baseline to 12 weeks, expressed in number of hops completed

  2. Anterior Cruciate Ligament Return to Sport After Injury Scale [ Time Frame: 12 months ]
    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).


Secondary Outcome Measures :
  1. Test Battery to Assess Postural Orientation During Functional Tasks [ Time Frame: 12 weeks ]
    Single-leg Squat, Stair Descending, Forward Lunge, Single-leg hop for distance will be used to evaluate postural orientation by visual film review in which knee medial to foot position is assessed and given a score of either 0 ("good postural orientation" i.e. presents no signs of postural orientation errors), 1 ("fair" i.e. presents signs of postural orientation errors), 2 ("poor" i.e. presents clear signs of postural orientation errors), or 3 ("very poor" i.e. the execution of the test does not have any similarities to the task).

  2. Hop Test Battery [ Time Frame: 12 weeks ]
    Results of side hop and single-leg hop for distance tasks, expressed in percent Limb Symmetry Index (LSI)

  3. Knee Injury and Osteoarthritis Outcome Score [ Time Frame: 12 weeks; 12 month follow-up ]
    Self-reported outcome scale measuring 5 aspects of knee function and symptoms. Subscales include: "Symptoms" - 7 questions; "Pain" - 9 questions; "Function, daily living" - 17 questions; "Function, sports and recreational activities" - 5 questions; "Quality of life" - 4 questions. Responses are given on a 5-point likert scale. Each subscale is given a 0 (extreme symptoms) - 100 (no symptoms) normalized score. A total score will not be presented.

  4. Rehabilitation Outcome Satisfaction [ Time Frame: 12 months; 12 month follow-up ]
    1 self-reported outcome question regarding the satisfaction with rehabilitation. Scores range from 3 ("happy") to -3 ("unhappy").

  5. Perceived Stress Scale [ Time Frame: 12 weeks; 12 month follow-up ]
    Self-reported outcome scale measuring perceived stress. Ten questions on a 5-point likert scale will provide a score from 0 - 40. Score of 0-13 are considered low stress, 14-26 are considered moderate stress, and 27-40 are considered high stress.

  6. Motivation [ Time Frame: 12 weeks; 12 month follow-up ]
    3 questions regarding motivation in regards to return to sport. Scores on a 1 (worst) - 10 (best) scale for each question will be presented individually.

  7. Physical Activity Enjoyment Scale [ Time Frame: 12 weeks; 12 month follow-up ]
    Self-reported outcome scale measuring the perceived enjoyment in an activity. 18 bipolar statements are evaluated on a 7-point likert scale. 11 items are reverse scored. Higher scores indicate greater enjoyment.

  8. Patient Enablement Instrument [ Time Frame: 12 weeks ]
    Self-reported outcome scale measuring the degree of enablement a patient feels (control, understanding, etc) on a 3-point scale where 0 is "not relevant" or "same or less", 1 is "better" and 3 is "much better." The total score is presented as 0-12, with higher scores reflecting higher enablement.

  9. Compliance to intervention in minutes [ Time Frame: 12 weeks ]
    Attendance and participation in rehabilitation activities. Attendance will be reported by the physical therapist (yes/no, minutes). The patient will answer weekly self-reported questions regarding the amount of time engaged in either care as usual or MOTIFS training, both at home and supervised), presented in number of occasions and minutes.

  10. Tegner Activity Scale [ Time Frame: 12 months ]
    Pre-injury, present and final activity level to determine return to sport

  11. Phenomenological Interview [ Time Frame: 12 weeks ]
    Interview regarding subjective experiences of rehabilitation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Any degenerative knee disorder, or other disease or disorder overriding the knee injury (e.g. spine disorder, neurological disease)
  • Have reached end-stage rehabilitation (i.e. have undergone return to activity evaluation by their physical therapist) or is estimated to return less than 12 weeks from inclusion date
  • Do not understand the languages of interest (Swedish, Danish, Norwegian), or English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473821


Contacts
Layout table for location contacts
Contact: Eva Ageberg, PhD (+46)46-222 49 43 eva.ageberg@med.lu.se
Contact: Niklas Cederström, MSc niklas.cederstrom@med.lu.se

Locations
Layout table for location information
Sweden
Lund University Recruiting
Lund, Skåne, Sweden, 221 00
Contact: Eva Ageberg, PhD    (+46)46-222 49 43    eva.ageberg@med.lu.se   
Contact: Niklas Cederström, MSc       niklas.cederstrom@med.lu.se   
Sub-Investigator: Niklas Cederström, MsC         
Principal Investigator: Eva Ageberg, PhD         
Sub-Investigator: Simon Granér, PhD         
Sponsors and Collaborators
Lund University
Investigators
Layout table for investigator information
Principal Investigator: Eva Ageberg, PhD Lund University
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site

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

Layout table for additonal information
Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03473821    
Other Study ID Numbers: Dnr 2016/413
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (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

URL: https://lucris.lub.lu.se/ws/portalfiles/portal/87841584/MOTIFS_Data_Management_Protocol_1.0_2020_12_10.pdf

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lund University:
ACL Injury
Return to Sport
Mental Training
Dynamic Motor Imagery
Anterior Cruciate Ligament
Knee Injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries