Motor Imagery to Facilitate Sensorimotor Relearning After ACL Injury (MOTIFS)
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|ClinicalTrials.gov Identifier: NCT03473821|
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : April 29, 2022
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|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|
|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|
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.
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.
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.
- 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
- 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).
- 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).
- 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)
- 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.
- 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").
- 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.
- 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.
- 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.
- 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.
- 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.
- Tegner Activity Scale [ Time Frame: 12 months ]Pre-injury, present and final activity level to determine return to sport
- Phenomenological Interview [ Time Frame: 12 weeks ]Interview regarding subjective experiences of rehabilitation
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
|Contact: Eva Ageberg, PhD||(+46)46-222 49 firstname.lastname@example.org|
|Contact: Niklas Cederström, MScemail@example.com|
|Lund, Skåne, Sweden, 221 00|
|Contact: Eva Ageberg, PhD (+46)46-222 49 43 firstname.lastname@example.org|
|Contact: Niklas Cederström, MSc email@example.com|
|Sub-Investigator: Niklas Cederström, MsC|
|Principal Investigator: Eva Ageberg, PhD|
|Sub-Investigator: Simon Granér, PhD|
|Principal Investigator:||Eva Ageberg, PhD||Lund University|