Anterior Cruciate Ligament RuptureMIRACLNCT05168033
Motor Imagery After Reconstruction of the Anterior Cruciate Ligament
A study testing Motor imagery training and Classic rehabilitation in people with Anterior Cruciate Ligament Rupture and Motor Imagery, run by University Ghent at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anterior Cruciate Ligament Rupture, Motor Imagery
- What is being tested?
- Motor imagery training and Classic rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2021to 30 Apr 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Anterior cruciate ligament reconstruction
- Rehabilitation at the sports physiotherapy department of the Ghent University Hospital
Who cannot join
- Neurological disorders or diseases that could affect motor imagery training
- Musculoskeletal or cognitive disorders that interfere with the normal function of the lower extremities
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University, Department of Rehabilitation Sciences
Ghent
Sander Denolf, Msc, +32 (0)9 332 69 17, sander.denolf@ugent.be
About this study
Official title: The Effect of Motor Imagery as an Additional Tool During the Rehabilitation After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Rupture, Motor Imagery
- Being tested
- Motor imagery training, Classic rehabilitation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imagery trainingOther
Also called Mental practice
Mentally imagine to perform rehabilitation exercises or sport-specific tasks without generating actual motor output.
Classic rehabilitationOther
Classic rehabilitation after anterior cruciate ligament reconstruction focusing on regaining mobility, stability and strength of the knee joint and return to sport.
| Study group | Role | What they receive |
|---|---|---|
| Motor imagery training | Experimental | In addition to classic rehabilitation the experimental group will be assigned to motor imagery training.
This training will take place at 3 specific periods (4 weeks) during the rehabilitation process:
MI 1: immediately postoperative; MI 2: return to run; MI 3: change of directions and cutting;
To complete a motor imagery training session, participants of the experimental group will have to watch video clips in which rehabilitation exercises or sport specific situations will be shown. After watching, participants will have to mentally imagine they are performing these exercises themselves without actually moving. During each of the 3 motor imagery periods, subjects will be required to complete 20 sessions of 10-15 minutes each. Receives: Other: Motor imagery training; Other: Classic rehabilitation |
| Classic rehabilitation | Active comparator | This group will follow the classic rehabilitation pathway after anterior cruciate ligament reconstruction. Receives: Other: Classic rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire
Assess the patients opinion about their knee and associated problems. Each item is given a score between 0 and 4, then the total score is converted to a scale of 0-100. A higher score indicates less disfunction.
Measured: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
ACL-Return to sport after injury (ACL-RSI) - Questionnaire
This questionnaire consists of 12 questions divided into three main sections: athletes' emotion, confidence, and risk assessment when returning to sport after an ACL injury and/or reconstructive surgery.
Each item is given a score between 0 and 100, after which the total score is converted to a scale of 0-100. A lower score indicates more concerns about return to sport.
Measured: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Visual Analogue Scale (VAS) - Questionnaire
A validated, subjective measure for acute and chronic pain (0-100). A higher score indicates more pain.
Measured: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Knee confidence - Questionnaire
To evaluate the confidence of patients in their operated knee, expressed as a percentage relative to the nonoperated side (0-100%). A lower score indicates less confidence.
Measured: From preoperative screening (1 week before surgery) until end of follow up (15 months postoperative)
Limb circumference
Knee effusion is measured by a tape measure at 2 different points on the thigh (5 cm and 15 cm above the patella).
Measured: From preoperative screening (1 week before surgery) until 4 weeks postoperative
Knee Flexion and Extension Range of Motion
Using a goniometer, knee flexion and extension range of motion of the knee joint will be measured.
Measured: From preoperative screening (1 week before surgery) until 4 weeks postoperative
Quadriceps muscle strength
Using a handheld dynamometer the strenght of the quadriceps muscle will be measured.
Measured: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Balance
Dynamic balance will be measured using the Y-balance test - lower quadrant
Measured: From 8 weeks postoperative until return to sport screening (28 weeks postoperative)
Hop tests
Single leg hop for distance, vertical jump and side hop. These tests will compare the affected and non-affected side (Limb Symmetry Index) in the context of return to sport readiness.
Measured: From 16 weeks postoperative until return to sport screening (28 weeks postoperative)
Change in movement quality
Lateral step down, drop vertical jump and a cutting maneuver task are assessed for movement quality using a 2D video camera setup.
Measured: Respectively from 8, 12 and 24 weeks postoperative until return to sport screening (28 weeks postoperative)
Secondary outcomes (4)
Penn State Worry Questionnaire (PSWQ) - Questionnaire
This questionnaire consists of 16 questions and evaluates the extent to which patients are concerned
Each item is given a score between 1 and 5. The total scores range from 16 to 80 with higher scores indicative of higher levels of trait worry.
Measured: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Tampa scale of Kinesiophobia (TSK) - Questionnaire
This questionnaire consists of 17 questions and evaluates the extent to which patients experience kinsiophobia.
Each item is given a score between 0 and 4. A higher score indicates more kinesiophobia.
Measured: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Resting state brain activity
Electroencephalography (EEG) will be recorded from 128 Sn surface electrodes using an electrode cap during 5 minutes of sitting on a chair. Spectral power will be analyzed.
Measured: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Event-related potentials
Electroencephalography (EEG) will be recorded from 128 Sn surface electrodes using an electrode cap during 2x5 minutes of watching videoclips. Spectral power will be analyzed.
Measured: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start15 Nov 2021
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Witvrouw, Prof. dr., Principal investigator, Department of Rehabilitation Sciences, Ghent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168033
- Sponsor's protocol ID
- B6702021000881
- Acronym
- MIRACL
- Status last verified
- Dec 2023
- First submitted
- 9 Nov 2021
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motor Imagery as an Additional Tool During the Rehabilitation After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05168033
- Acronym / sponsor ID
- MIRACL / B6702021000881
- Conditions
- Anterior Cruciate Ligament Rupture, Motor Imagery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 23 Dec 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor imagery training | Experimental | Other: Motor imagery training, Other: Classic rehabilitationIn addition to classic rehabilitation the experimental group will be assigned to motor imagery training. This training will take place at 3 specific periods (4 weeks) during the rehabilitation process: MI 1: immediately postoperative; MI 2: return to run; MI 3: change of directions and cutting; To complete a motor imagery training session, participants of the experimental group will have to watch video clips in which rehabilitation exercises or sport specific situations will be shown. After watching, participants will have to mentally imagine they are performing these exercises themselves without actually moving. During each of the 3 motor imagery periods, subjects will be required to complete 20 sessions of 10-15 minutes each. |
| Classic rehabilitation | Active comparator | Other: Classic rehabilitationThis group will follow the classic rehabilitation pathway after anterior cruciate ligament reconstruction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Anterior cruciate ligament reconstruction
- Rehabilitation at the sports physiotherapy department of the Ghent University Hospital
Key exclusion criteria (2 listed)
- Neurological disorders or diseases that could affect motor imagery training
- Musculoskeletal or cognitive disorders that interfere with the normal function of the lower extremities
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 |
|---|---|---|
| Motor imagery trainingAlso: Mental practiceMentally imagine to perform rehabilitation exercises or sport-specific tasks without generating actual motor output. | Other | Motor imagery training |
| Classic rehabilitationClassic rehabilitation after anterior cruciate ligament reconstruction focusing on regaining mobility, stability and strength of the knee joint and return to sport. | Other | Classic rehabilitation, Motor imagery training |
Primary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire
Time frame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Assess the patients opinion about their knee and associated problems. Each item is given a score between 0 and 4, then the total score is converted to a scale of 0-100. A higher score indicates less disfunction.
ACL-Return to sport after injury (ACL-RSI) - Questionnaire
Time frame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
This questionnaire consists of 12 questions divided into three main sections: athletes' emotion, confidence, and risk assessment when returning to sport after an ACL injury and/or reconstructive surgery. Each item is given a score between 0 and 100, after which the total score is converted to a scale of 0-100. A lower score indicates more concerns about return to sport.
Visual Analogue Scale (VAS) - Questionnaire
Time frame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
A validated, subjective measure for acute and chronic pain (0-100). A higher score indicates more pain.
Knee confidence - Questionnaire
Time frame: From preoperative screening (1 week before surgery) until end of follow up (15 months postoperative)
To evaluate the confidence of patients in their operated knee, expressed as a percentage relative to the nonoperated side (0-100%). A lower score indicates less confidence.
Limb circumference
Time frame: From preoperative screening (1 week before surgery) until 4 weeks postoperative
Knee effusion is measured by a tape measure at 2 different points on the thigh (5 cm and 15 cm above the patella).
Knee Flexion and Extension Range of Motion
Time frame: From preoperative screening (1 week before surgery) until 4 weeks postoperative
Using a goniometer, knee flexion and extension range of motion of the knee joint will be measured.
Quadriceps muscle strength
Time frame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Using a handheld dynamometer the strenght of the quadriceps muscle will be measured.
Balance
Time frame: From 8 weeks postoperative until return to sport screening (28 weeks postoperative)
Dynamic balance will be measured using the Y-balance test - lower quadrant
Hop tests
Time frame: From 16 weeks postoperative until return to sport screening (28 weeks postoperative)
Single leg hop for distance, vertical jump and side hop. These tests will compare the affected and non-affected side (Limb Symmetry Index) in the context of return to sport readiness.
Change in movement quality
Time frame: Respectively from 8, 12 and 24 weeks postoperative until return to sport screening (28 weeks postoperative)
Lateral step down, drop vertical jump and a cutting maneuver task are assessed for movement quality using a 2D video camera setup.
4 secondary outcomes
Penn State Worry Questionnaire (PSWQ) - Questionnaire
Time frame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Tampa scale of Kinesiophobia (TSK) - Questionnaire
Time frame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Resting state brain activity
Time frame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Event-related potentials
Time frame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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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.
Erik Witvrouw, Prof. dr. principal investigator
Department of Rehabilitation Sciences, Ghent 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 Motor imagery training and Classic rehabilitation in people with Anterior Cruciate Ligament Rupture and Motor Imagery, run by University Ghent at 1 site in Belgium.
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 2 inclusion and 2 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 11 Dec 2023. 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 Belgium. 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?
Contact Sander Denolf (+32498400463, sander.denolf@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire (time frame: From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2023.