Clinical trial NCT05168033: Motor Imagery After Reconstruction of the Anterior Cruciate Ligament
Official title: The Effect of Motor Imagery as an Additional Tool During the Rehabilitation After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Motor Imagery
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to investigate the effect of motor imagery training as an additional tool in the rehabilitation after anterior cruciate ligament reconstruction (ACLR). Therefore, ACLR patients will be recruited and randomly assigned into one of following groups:

* Experimental group: Classic rehabilitation + Motor imagery training
* Control group: Classic rehabilitation

Both, the control and experimental group, will be submitted to a routine physiotherapy program after ACLR. In addition, the intervention group will be exposed to motor imagery training at three different time periods during the rehabilitation process (MI 1: immediately postoperative; MI 2: return to run; MI 3: change of direction). All participants will be invited for a preoperative screening, several postoperative screenings at 4-week time intervals and a final return to sport screening. At these test moments, participants will be subjected to a specific test battery consisting of subjective and objective clinical parameters. The subjective outcomes imply the patient's perception of pain and discomfort, level of participation, psychosocial well-being and overall quality of life. The objective clinical outcome measures relate to knee mobility and muscle strength, level of functioning/performance capacity and the detection of brain areas and networks involved in the processes of anxiety and worrying using EEG.

Detailed description: To investigate the effect of motor imagery training in addition to classical rehabilitation after anterior cruciate ligament reconstruction, a randomized study with prospective follow-up will be set up in an adult population of both male and female subjects.

After recruitment, patients who are eligible to participate in the study will be randomly assigned to either the experimental group or the control group. Both groups will follow the standard rehabilitation program after anterior cruciate ligament reconstruction to promote mobility, strength, proprioception, stability and return to sport.

For the participants in the experimental group, motor imagery training will be included in the rehabilitation program, organized into 3 specific periods (4 weeks) during the rehabilitation process.

* MI 1: immediately postoperative (0-4w postop)
* MI 2: return to run (8-12w postop)
* MI 3: return to cutting and directional changes (16-20w postop)

These MI training sessions (MITS) will consist of watching video clips in which the subjects will be shown rehabilitation exercises or sport-specific situations. After watching, participants will have to mentally imagine they are performing these exercises themselves, without actually moving. It is important that subjects concentrate on all muscular, sensorimotor and proprioceptive sensations as they would occur during the effective performance of the exercise or task. During each of the 3 motor imagery periods, subjects will be required to complete 20 sessions of 10-15 minutes each.

Participants from the experimental group will be subjected to a specific test battery preoperatively and before and after each motor imagery training period, tailored to the stage of the rehabilitation process. Control group participants will also be subjected to this specific test battery at similar times in the rehabilitation process (preoperative, 0w, 4w, 8w, 12w, 16w, 20w and RTS testing).

Finally, all participants (experimental group + control group) will be contacted by telephone at 3 months and 1 year after the last screening to ask them about the type of sport they practice, at which level they practice this sport, how much confidence they have in their operated knee during sports and any new injuries.

Eligibility criteria: Inclusion Criteria:

* Anterior cruciate ligament reconstruction
* Rehabilitation at the sports physiotherapy department of the Ghent University Hospital

Exclusion Criteria:

* Neurological disorders or diseases that could affect motor imagery training
* Musculoskeletal or cognitive disorders that interfere with the normal function of the lower extremities

Primary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire
timeFrame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
measure: ACL-Return to sport after injury (ACL-RSI) - Questionnaire
timeFrame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
measure: Visual Analogue Scale (VAS) - Questionnaire
timeFrame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
measure: Knee confidence - Questionnaire
timeFrame: From preoperative screening (1 week before surgery) until end of follow up (15 months postoperative)
measure: Limb circumference
timeFrame: From preoperative screening (1 week before surgery) until 4 weeks postoperative
measure: Knee Flexion and Extension Range of Motion
timeFrame: From preoperative screening (1 week before surgery) until 4 weeks postoperative
measure: Quadriceps muscle strength
timeFrame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
measure: Balance
timeFrame: From 8 weeks postoperative until return to sport screening (28 weeks postoperative)
measure: Hop tests
timeFrame: From 16 weeks postoperative until return to sport screening (28 weeks postoperative)
measure: Change in movement quality
timeFrame: Respectively from 8, 12 and 24 weeks postoperative until return to sport screening (28 weeks postoperative)
Secondary outcomes:
measure: Penn State Worry Questionnaire (PSWQ) - Questionnaire
timeFrame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
measure: Tampa scale of Kinesiophobia (TSK) - Questionnaire
timeFrame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
measure: Resting state brain activity
timeFrame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
measure: Event-related potentials
timeFrame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University, Department of Rehabilitation Sciences
Study officials:
affiliation: Department of Rehabilitation Sciences, Ghent University
name: Erik Witvrouw, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: