Anterior Cruciate Ligament InjuryMOTIFSNCT03473821
Motor Imagery to Facilitate Sensorimotor Relearning After ACL Injury
A study testing MOTIFS in people with Anterior Cruciate Ligament Injury, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- MOTIFS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSweden
- Study dates
- 25 Mar 2018to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- MOTIFS
- Keywords
- ACL Injury, Return to Sport, Mental Training, Dynamic Motor Imagery, Anterior Cruciate Ligament, Knee Injury
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOTIFSBehavioural
Also called Neuromuscular Training Plus Mental Training, Train the Brain Model
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular Training | No intervention | 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. |
| MOTIFS | Experimental | 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. Receives: Behavioral: MOTIFS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side Hop
Change in hop performance on the injured leg from baseline to 12 weeks, expressed in number of hops completed
Measured: 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).
Measured: 12 months
Secondary outcomes (11)
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).
Measured: 12 weeks
Hop Test Battery
Results of side hop and single-leg hop for distance tasks, expressed in percent Limb Symmetry Index (LSI)
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Tegner Activity Scale
Pre-injury, present and final activity level to determine return to sport
Measured: 12 months
Phenomenological Interview
Interview regarding subjective experiences of rehabilitation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start25 Mar 2018
- Primary completion6 Jun 2023
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 single assessor-blinded adaptive randomized controlled trial, which will conform to the CONSORT statement
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eva Ageberg, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473821
- Sponsor's protocol ID
- Dnr 2016/413
- Acronym
- MOTIFS
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2018
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Ageberg E, Thomee R, Neeter C, Silbernagel KG, Roos EM. Muscle strength and functional performance in patients with anterior cruciate ligament injury treated with training and surgical reconstruction or training only: a two to five-year followup. Arthritis Rheum. 2008 Dec 15;59(12):1773-9. doi: 10.1002/art.24066.
PubMed 19035430Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.
PubMed 20660401Ardern CL, Taylor NF, Feller JA, Webster KE. Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med. 2014 Nov;48(21):1543-52. doi: 10.1136/bjsports-2013-093398. Epub 2014 Aug 25.
PubMed 25157180Ardern CL, Webster KE, Taylor NF, Feller JA. Return to sport following anterior cruciate ligament reconstruction surgery: a systematic review and meta-analysis of the state of play. Br J Sports Med. 2011 Jun;45(7):596-606. doi: 10.1136/bjsm.2010.076364. Epub 2011 Mar 11.
PubMed 21398310Risberg MA, Grindem H, Oiestad BE. We Need to Implement Current Evidence in Early Rehabilitation Programs to Improve Long-Term Outcome After Anterior Cruciate Ligament Injury. J Orthop Sports Phys Ther. 2016 Sep;46(9):710-3. doi: 10.2519/jospt.2016.0608.
PubMed 27581178Guillot A, Moschberger K, Collet C. Coupling movement with imagery as a new perspective for motor imagery practice. Behav Brain Funct. 2013 Feb 20;9:8. doi: 10.1186/1744-9081-9-8.
PubMed 23425312Smith 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.
Grooms DR, Page SJ, Onate JA. Brain Activation for Knee Movement Measured Days Before Second Anterior Cruciate Ligament Injury: Neuroimaging in Musculoskeletal Medicine. J Athl Train. 2015 Oct;50(10):1005-10. doi: 10.4085/1062-6050-50.10.02. Epub 2015 Sep 29.
PubMed 26509775Holmes 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
Webster KE, Feller JA, Lambros C. Development and preliminary validation of a scale to measure the psychological impact of returning to sport following anterior cruciate ligament reconstruction surgery. Phys Ther Sport. 2008 Feb;9(1):9-15. doi: 10.1016/j.ptsp.2007.09.003. Epub 2007 Nov 5.
PubMed 19083699Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.
PubMed 4028566Gustavsson A, Neeter C, Thomee P, Silbernagel KG, Augustsson J, Thomee R, Karlsson J. A test battery for evaluating hop performance in patients with an ACL injury and patients who have undergone ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2006 Aug;14(8):778-88. doi: 10.1007/s00167-006-0045-6. Epub 2006 Mar 9.
PubMed 16525796Nae J, Creaby MW, Cronstrom A, Ageberg E. Measurement properties of visual rating of postural orientation errors of the lower extremity - A systematic review and meta-analysis. Phys Ther Sport. 2017 Sep;27:52-64. doi: 10.1016/j.ptsp.2017.04.003. Epub 2017 Apr 18.
PubMed 28647205Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
PubMed 9699158
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Imagery to Facilitate Sensorimotor Relearning (MOTIFS) After ACL Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03473821
- Acronym / sponsor ID
- MOTIFS / Dnr 2016/413
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- ACL Injury, Return to Sport, Mental Training, Dynamic Motor Imagery, Anterior Cruciate Ligament, Knee Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 25 Mar 2018 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 single assessor-blinded adaptive randomized controlled trial, which will conform to the CONSORT statement
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular Training | No intervention | –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. |
| MOTIFS | Experimental | Behavioral: MOTIFSParticipants 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOTIFSAlso: Neuromuscular Training Plus Mental Training, Train the Brain Modelo 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. | Behavioural | MOTIFS |
Primary outcome
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).
11 secondary outcomes
Test Battery to Assess Postural Orientation During Functional Tasks
Time frame: 12 weeks
Hop Test Battery
Time frame: 12 weeks
Knee Injury and Osteoarthritis Outcome Score
Time frame: 12 weeks; 12 month follow-up
Rehabilitation Outcome Satisfaction
Time frame: 12 months; 12 month follow-up
Perceived Stress Scale
Time frame: 12 weeks; 12 month follow-up
Motivation
Time frame: 12 weeks; 12 month follow-up
Physical Activity Enjoyment Scale
Time frame: 12 weeks; 12 month follow-up
Patient Enablement Instrument
Time frame: 12 weeks
Compliance to intervention in minutes
Time frame: 12 weeks
Tegner Activity Scale
Time frame: 12 months
Phenomenological Interview
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Background: PubMed 19035430Ageberg E, Thomee R, Neeter C, Silbernagel KG, Roos EM. Muscle strength and functional performance in patients with anterior cruciate ligament injury treated with training and surgical reconstruction or training only: a two to five-year followup. Arthritis Rheum. 2008 Dec 15;59(12):1773-9. doi: 10.1002/art.24066.
- Background: PubMed 20660401Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.
- Background: PubMed 25157180Ardern CL, Taylor NF, Feller JA, Webster KE. Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med. 2014 Nov;48(21):1543-52. doi: 10.1136/bjsports-2013-093398. Epub 2014 Aug 25.
- Background: PubMed 21398310Ardern CL, Webster KE, Taylor NF, Feller JA. Return to sport following anterior cruciate ligament reconstruction surgery: a systematic review and meta-analysis of the state of play. Br J Sports Med. 2011 Jun;45(7):596-606. doi: 10.1136/bjsm.2010.076364. Epub 2011 Mar 11.
- Background: PubMed 27581178Risberg MA, Grindem H, Oiestad BE. We Need to Implement Current Evidence in Early Rehabilitation Programs to Improve Long-Term Outcome After Anterior Cruciate Ligament Injury. J Orthop Sports Phys Ther. 2016 Sep;46(9):710-3. doi: 10.2519/jospt.2016.0608.
- Background: PubMed 23425312Guillot A, Moschberger K, Collet C. Coupling movement with imagery as a new perspective for motor imagery practice. Behav Brain Funct. 2013 Feb 20;9:8. doi: 10.1186/1744-9081-9-8.
- BackgroundSmith D, et al. It's All in the Mind: PETTLEP-Based Imagery and Sports Performance. J Appl Sport Psychol 2007;19:80-92.
- BackgroundCumming 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.
- Background: PubMed 26509775Grooms DR, Page SJ, Onate JA. Brain Activation for Knee Movement Measured Days Before Second Anterior Cruciate Ligament Injury: Neuroimaging in Musculoskeletal Medicine. J Athl Train. 2015 Oct;50(10):1005-10. doi: 10.4085/1062-6050-50.10.02. Epub 2015 Sep 29.
- BackgroundHolmes 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
- Background: PubMed 19083699Webster KE, Feller JA, Lambros C. Development and preliminary validation of a scale to measure the psychological impact of returning to sport following anterior cruciate ligament reconstruction surgery. Phys Ther Sport. 2008 Feb;9(1):9-15. doi: 10.1016/j.ptsp.2007.09.003. Epub 2007 Nov 5.
- Background: PubMed 4028566Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.
- Individual participant dataSharing planned: 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.
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Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Ageberg, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOTIFS in people with Anterior Cruciate Ligament Injury, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side Hop (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03473821, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.