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

February 24, 2023 updated by: Lund University

Motor Imagery to Facilitate Sensorimotor Relearning (MOTIFS) After ACL Injury: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Anterior Cruciate Ligament (ACL) injury is increasingly common in sports involving jumping and cutting. Treatment for such injuries most often includes physical therapist-supervised rehabilitation, with or without surgical reconstruction. Care-as-usual rehabilitation often includes neuromuscular training in order to improve function and reduce knee-related symptoms. Recent data shows that 90% of athletes undergoing rehabilitation achieved normal or nearly-normal knee function when measured in strength and knee laxity. Despite this number, 56% of these athletes did not return to sport or pre-injury activity levels. Due to this imbalance, the question is raised of whether there is a potential to supplement care-as-usual in order to improve upon current rehabilitative training programs.

One attractive alternative is the use of dynamic motor imagery (DMI), which is a form of mental training intended to increase functional equivalence. This is done by imaging an activity-specific and relevant movement while simultaneously completing a similar movement, thereby simulating a real-life physical activity movement. This approach makes it possible to create a situation in which a person is able to create meaning and find relevance in movement used in a rehabilitative training environment.

In this study, the investigators aim to create and test a new training model, referred to as MOTor Imagery to Facilitate Sensorimotor re-learning (MOTIFS), and compare the efficacy of neuromuscular training plus dynamic motor imagery vs neuromuscular training alone in terms of muscle function and patient-reported outcomes in people with an ACL injury and with a goal of returning to pre-injury level of activity.

Primary Hypothesis: 12 weeks of neuromuscular training plus dynamic motor imagery will improve muscle function, measured by relative change in hop performance in the injured leg in side hop test, and patient-reported measures of psychological readiness to return to sport to a greater extent and with a quicker onset of recovery than neuromuscular training alone.

Methods:

In this randomized controlled trial, the inclusion criteria are as follows: (i) male and female ACL-injured people, (ii) over the age of 16, (iii) ACL injury or reconstruction with or without associated injuries to other knee structures, (iii) currently undergoing rehabilitation, (iv) active in recreational or competitive physical activity prior to the injury, and (v) have a goal of reaching pre-injury activity level. Exclusion criteria for participants include: (i) a disease or disorder overriding the knee injury, (ii) have undergone return-to-activity evaluation by a physical therapist, and (iii) do not understand a Scandinavian language (Swedish, Danish, Norwegian) or English.

Those participants randomized to the care-as-usual group will receive rehabilitation according to standard practices.

The experimental group will receive standard training which has been supplemented with the dynamic motor imagery in the MOTIFS model. In this experimental condition, physical therapists will be educated in the use of the new training model and will administer it during clinical practice with the participants. The new model includes information intended to open a dialogue with the participant in order to create a mental simulation in which the participant is able to mentally create a realistic and relevant situation in order to maximize the meaning and motivation of the rehabilitation exercises. This may include the use of sporting equipment, such as balls or sticks, in order to make the rehabilitation session seem as similar to a training session in the relevant sport as possible.

Outcomes:

At baseline and 12 weeks, participants will be measured in patient-reported outcomes, hop ability, and will be filmed in a series of functional tests in order to evaluate postural orientation errors. The main outcomes are relative change in hop performance on the injured leg in a side hop test, and psychological readiness to return to sport (ACL Return to Sport After Injury Scale). Secondary outcomes include a hop test battery (single-leg hop for distance and sidehop), postural orientation errors (single-leg squat, stair descending, forward lunge, side hop, and single-leg hop for distance), Knee Osteoarthritis Outcome Score, Rehabilitation Outcome Satisfaction, Motivation, Patient Enablement Instrument, Physical Activity Enjoyment Scale, and the Tegner Activity scale. A subgroup of both physical therapists and patients will also be asked a series of open-ended questions in a phenomenological interview upon completion of the intervention.

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Skåne
      • Lund, Skåne, Sweden, 221 00
        • Recruiting
        • Lund University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Niklas Cederström, MsC
        • Principal Investigator:
          • Eva Ageberg, PhD
        • Sub-Investigator:
          • Simon Granér, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks
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)
12 weeks
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.
12 weeks; 12 month follow-up
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").
12 months; 12 month follow-up
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.
12 weeks; 12 month follow-up
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.
12 weeks; 12 month follow-up
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.
12 weeks; 12 month follow-up
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.
12 weeks
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.
12 weeks
Tegner Activity Scale
Time Frame: 12 months
Pre-injury, present and final activity level to determine return to sport
12 months
Phenomenological Interview
Time Frame: 12 weeks
Interview regarding subjective experiences of rehabilitation
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Investigators

  • Principal Investigator: Eva Ageberg, PhD, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2018

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 15, 2018

First Posted (Actual)

March 22, 2018

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2016/413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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)

IPD Sharing Access Criteria

Data may be shared upon reasonable request by contacting the corresponding author:

Niklas Cederström niklas.cederstrom@med.lu.se

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Study Data/Documents

  1. Statistical Analysis Plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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