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

Primary Purpose

Anterior Cruciate Ligament Injury

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
MOTIFS
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring ACL Injury, Return to Sport, Mental Training, Dynamic Motor Imagery, Anterior Cruciate Ligament, Knee Injury

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lund UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Neuromuscular Training

MOTIFS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Test Battery to Assess Postural Orientation During Functional Tasks
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).
Hop Test Battery
Results of side hop and single-leg hop for distance tasks, expressed in percent Limb Symmetry Index (LSI)
Knee Injury and Osteoarthritis Outcome Score
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.
Rehabilitation Outcome Satisfaction
1 self-reported outcome question regarding the satisfaction with rehabilitation. Scores range from 3 ("happy") to -3 ("unhappy").
Perceived Stress Scale
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.
Motivation
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.
Physical Activity Enjoyment Scale
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.
Patient Enablement Instrument
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.
Compliance to intervention in minutes
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.
Tegner Activity Scale
Pre-injury, present and final activity level to determine return to sport
Phenomenological Interview
Interview regarding subjective experiences of rehabilitation

Full Information

First Posted
February 28, 2018
Last Updated
February 24, 2023
Sponsor
Lund University
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1. Study Identification

Unique Protocol Identification Number
NCT03473821
Brief Title
Motor Imagery to Facilitate Sensorimotor Relearning After ACL Injury
Acronym
MOTIFS
Official Title
Motor Imagery to Facilitate Sensorimotor Relearning (MOTIFS) After ACL Injury: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2018 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury
Keywords
ACL Injury, Return to Sport, Mental Training, Dynamic Motor Imagery, Anterior Cruciate Ligament, Knee Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 single assessor-blinded adaptive randomized controlled trial, which will conform to the CONSORT statement
Masking
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
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular Training
Arm Type
No Intervention
Arm Description
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.
Arm Title
MOTIFS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MOTIFS
Other Intervention Name(s)
Neuromuscular Training Plus Mental Training, Train the Brain Model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Side Hop
Description
Change in hop performance on the injured leg from baseline to 12 weeks, expressed in number of hops completed
Time Frame
12 weeks
Title
Anterior Cruciate Ligament Return to Sport After Injury Scale
Description
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).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Test Battery to Assess Postural Orientation During Functional Tasks
Description
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).
Time Frame
12 weeks
Title
Hop Test Battery
Description
Results of side hop and single-leg hop for distance tasks, expressed in percent Limb Symmetry Index (LSI)
Time Frame
12 weeks
Title
Knee Injury and Osteoarthritis Outcome Score
Description
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.
Time Frame
12 weeks; 12 month follow-up
Title
Rehabilitation Outcome Satisfaction
Description
1 self-reported outcome question regarding the satisfaction with rehabilitation. Scores range from 3 ("happy") to -3 ("unhappy").
Time Frame
12 months; 12 month follow-up
Title
Perceived Stress Scale
Description
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.
Time Frame
12 weeks; 12 month follow-up
Title
Motivation
Description
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.
Time Frame
12 weeks; 12 month follow-up
Title
Physical Activity Enjoyment Scale
Description
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.
Time Frame
12 weeks; 12 month follow-up
Title
Patient Enablement Instrument
Description
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.
Time Frame
12 weeks
Title
Compliance to intervention in minutes
Description
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.
Time Frame
12 weeks
Title
Tegner Activity Scale
Description
Pre-injury, present and final activity level to determine return to sport
Time Frame
12 months
Title
Phenomenological Interview
Description
Interview regarding subjective experiences of rehabilitation
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Ageberg, PhD
Phone
(+46)46-222 49 43
Email
eva.ageberg@med.lu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Niklas Cederström, MSc
Email
niklas.cederstrom@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Ageberg, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University
City
Lund
State/Province
Skåne
ZIP/Postal Code
221 00
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Ageberg, PhD
Phone
(+46)46-222 49 43
Email
eva.ageberg@med.lu.se
First Name & Middle Initial & Last Name & Degree
Niklas Cederström, MSc
Email
niklas.cederstrom@med.lu.se
First Name & Middle Initial & Last Name & Degree
Niklas Cederström, MsC
First Name & Middle Initial & Last Name & Degree
Eva Ageberg, PhD
First Name & Middle Initial & Last Name & Degree
Simon Granér, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://lucris.lub.lu.se/admin/files/138815992/MOTIFS_Data_Management_Protocol_1.6_2023_02_24.pdf
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19035430
Citation
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Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://lucris.lub.lu.se/admin/files/138815992/MOTIFS_Data_Management_Protocol_1.6_2023_02_24.pdf

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Motor Imagery to Facilitate Sensorimotor Relearning After ACL Injury

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