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Motor Imagery After Reconstruction of the Anterior Cruciate Ligament (MIRACL)

Primary Purpose

Anterior Cruciate Ligament Rupture, Motor Imagery

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Motor imagery training
Classic rehabilitation
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Rupture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ghent University, Department of Rehabilitation SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motor imagery training

Classic rehabilitation

Arm Description

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.

This group will follow the classic rehabilitation pathway after anterior cruciate ligament reconstruction.

Outcomes

Primary Outcome Measures

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.
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.
Visual Analogue Scale (VAS) - Questionnaire
A validated, subjective measure for acute and chronic pain (0-100). A higher score indicates more pain.
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.
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).
Knee Flexion and Extension Range of Motion
Using a goniometer, knee flexion and extension range of motion of the knee joint will be measured.
Quadriceps muscle strength
Using a handheld dynamometer the strenght of the quadriceps muscle will be measured.
Balance
Dynamic balance will be measured using the Y-balance test - lower quadrant
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
November 9, 2021
Last Updated
December 7, 2022
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT05168033
Brief Title
Motor Imagery After Reconstruction of the Anterior Cruciate Ligament
Acronym
MIRACL
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture, Motor Imagery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motor imagery training
Arm Type
Experimental
Arm Description
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.
Arm Title
Classic rehabilitation
Arm Type
Active Comparator
Arm Description
This group will follow the classic rehabilitation pathway after anterior cruciate ligament reconstruction.
Intervention Type
Other
Intervention Name(s)
Motor imagery training
Other Intervention Name(s)
Mental practice
Intervention Description
Mentally imagine to perform rehabilitation exercises or sport-specific tasks without generating actual motor output.
Intervention Type
Other
Intervention Name(s)
Classic rehabilitation
Intervention Description
Classic rehabilitation after anterior cruciate ligament reconstruction focusing on regaining mobility, stability and strength of the knee joint and return to sport.
Primary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire
Description
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.
Time Frame
From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Title
ACL-Return to sport after injury (ACL-RSI) - Questionnaire
Description
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.
Time Frame
From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Title
Visual Analogue Scale (VAS) - Questionnaire
Description
A validated, subjective measure for acute and chronic pain (0-100). A higher score indicates more pain.
Time Frame
From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Title
Knee confidence - Questionnaire
Description
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.
Time Frame
From preoperative screening (1 week before surgery) until end of follow up (15 months postoperative)
Title
Limb circumference
Description
Knee effusion is measured by a tape measure at 2 different points on the thigh (5 cm and 15 cm above the patella).
Time Frame
From preoperative screening (1 week before surgery) until 4 weeks postoperative
Title
Knee Flexion and Extension Range of Motion
Description
Using a goniometer, knee flexion and extension range of motion of the knee joint will be measured.
Time Frame
From preoperative screening (1 week before surgery) until 4 weeks postoperative
Title
Quadriceps muscle strength
Description
Using a handheld dynamometer the strenght of the quadriceps muscle will be measured.
Time Frame
From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Title
Balance
Description
Dynamic balance will be measured using the Y-balance test - lower quadrant
Time Frame
From 8 weeks postoperative until return to sport screening (28 weeks postoperative)
Title
Hop tests
Description
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.
Time Frame
From 16 weeks postoperative until return to sport screening (28 weeks postoperative)
Title
Change in movement quality
Description
Lateral step down, drop vertical jump and a cutting maneuver task are assessed for movement quality using a 2D video camera setup.
Time Frame
Respectively from 8, 12 and 24 weeks postoperative until return to sport screening (28 weeks postoperative)
Secondary Outcome Measure Information:
Title
Penn State Worry Questionnaire (PSWQ) - Questionnaire
Description
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.
Time Frame
From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Title
Tampa scale of Kinesiophobia (TSK) - Questionnaire
Description
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.
Time Frame
From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Title
Resting state brain activity
Description
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.
Time Frame
From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)
Title
Event-related potentials
Description
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.
Time Frame
From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sander Denolf
Phone
+32498400463
Email
sander.denolf@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Witvrouw, Prof. dr.
Organizational Affiliation
Department of Rehabilitation Sciences, Ghent University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ghent University, Department of Rehabilitation Sciences
City
Ghent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sander Denolf, Msc
Phone
+32 (0)9 332 69 17
Email
sander.denolf@ugent.be

12. IPD Sharing Statement

Learn more about this trial

Motor Imagery After Reconstruction of the Anterior Cruciate Ligament

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