An interventional study of MOTIFS in Anterior Cruciate Ligament Injury, sponsored by Lund University. Active, not recruiting at 1 site in Sweden. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Lund University · Not applicable, Interventional, and Treatment
Among 12 studies in Anterior Cruciate Ligament Injuries with a site in Sweden — 2 open to participants now, 6 under way, none of them phase 3. Anterior Cruciate Ligament Injuries · Sweden.
Among the 12 studies in Anterior Cruciate Ligament Injuries with a site in Sweden, this one is one of 2 that started in 2018, is one of 5 with no phase, and was the 4th registered.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
Browse Anterior Cruciate Ligament Injuries studies →2 of the 12 studies in Anterior Cruciate Ligament Injuries with a site in Sweden are open now. Recruiting first, the newest first:
Karolinska Institutet · Sites in Sweden
Ages 16–40 · Healthy volunteers
Linnaeus University · Sites in Sweden
Ages 12–55
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 121 Anterior Cruciate Ligament Injuries studies recruiting now, 27 (22%) set no upper age limit and 91 (75%) stop at 75 or younger; 46 take children under 18; 21 take healthy volunteers.
This study: 16 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 2 started in 2018.
This study's planned enrollment of 106 is above the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Median enrollment 169 across the 5 interventional studies, 200 across the 7 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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None of the 12 has an industry lead sponsor. The 7 most frequent:
Lund University is the lead sponsor of 234 studies on the registry; 36 are open to participants now.
Lund University has 4 studies filed under Anterior Cruciate Ligament Injuries — fewer than ten, so there is no comparison to draw.
1 of the studies in Anterior Cruciate Ligament Injuries with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04295148Karolinska InstitutetSEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction | 2027-05-31 |
Among the 12 studies in Anterior Cruciate Ligament Injuries with a site in Sweden, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Also known as: Neuromuscular Training Plus Mental Training, Train the Brain Model
Side Hop
Change in hop performance on the injured leg from baseline to 12 weeks, expressed in number of hops completed
Time frame: 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).
Time frame: 12 months
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).
Time frame: 12 weeks
Hop Test Battery
Results of side hop and single-leg hop for distance tasks, expressed in percent Limb Symmetry Index (LSI)
Time frame: 12 weeks
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.
Time frame: 12 weeks; 12 month follow-up
Rehabilitation Outcome Satisfaction
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
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.
Time frame: 12 weeks; 12 month follow-up
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.
Time frame: 12 weeks; 12 month follow-up
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.
Time frame: 12 weeks; 12 month follow-up
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Tegner Activity Scale
Pre-injury, present and final activity level to determine return to sport
Time frame: 12 months
Phenomenological Interview
Interview regarding subjective experiences of rehabilitation
Time frame: 12 weeks
Plan to share: Yes — 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 information: Study protocol, Statistical analysis plan
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
Data sharing details ↗ · lucris.lub.lu.se
Ran from Mar 2018 to primary completion in Jun 2023, 62 months.
Of 277 non-industry interventional studies with no phase under Anterior Cruciate Ligament Injuries, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 70. This study's 62 months is above that.
Counting every sponsor, half of 286 studies reached it within 30 months; a quarter within 14 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Anterior Cruciate Ligament Injuries →