Anterior Cruciate Ligament Injury Clinical Trial
— MOTIFSOfficial title:
Motor Imagery to Facilitate Sensorimotor Relearning (MOTIFS) After ACL Injury: A Randomized Controlled Trial
Verified date | April 2024 |
Source | Lund University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 106 |
Est. completion date | June 2024 |
Est. primary completion date | June 6, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Lund University | Lund | Skåne |
Lead Sponsor | Collaborator |
---|---|
Lund University |
Sweden,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Side Hop | Change in hop performance on the injured leg from baseline to 12 weeks, expressed in number of hops completed | 12 weeks | |
Primary | 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). | 12 months | |
Secondary | 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). | 12 weeks | |
Secondary | Hop Test Battery | Results of side hop and single-leg hop for distance tasks, expressed in percent Limb Symmetry Index (LSI) | 12 weeks | |
Secondary | 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. | 12 weeks; 12 month follow-up | |
Secondary | Rehabilitation Outcome Satisfaction | 1 self-reported outcome question regarding the satisfaction with rehabilitation. Scores range from 3 ("happy") to -3 ("unhappy"). | 12 months; 12 month follow-up | |
Secondary | 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. | 12 weeks; 12 month follow-up | |
Secondary | 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. | 12 weeks; 12 month follow-up | |
Secondary | 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. | 12 weeks; 12 month follow-up | |
Secondary | 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. | 12 weeks | |
Secondary | 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. | 12 weeks | |
Secondary | Tegner Activity Scale | Pre-injury, present and final activity level to determine return to sport | 12 months | |
Secondary | Phenomenological Interview | Interview regarding subjective experiences of rehabilitation | 12 weeks |
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