Motor Imagery After Reconstruction of the Anterior Cruciate Ligament

NCT05168033 | Unknown

• 1 other identifier: B6702021000881
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Rupture; Motor Imagery

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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).

  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.

  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.

  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

  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.

  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.

  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

  From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)

• Tampa scale of Kinesiophobia (TSK) - Questionnaire

  From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)

• Resting state brain activity

  From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)

• Event-related potentials

  From preoperative screening (1 week before surgery) until return to sport screening (28 weeks postoperative)

Study Arms (2)

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.

Other: Motor imagery training; Other: Classic rehabilitation

Classic rehabilitation

ACTIVE COMPARATOR

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

Other: Classic rehabilitation

Interventions

Motor imagery training OTHER

Mentally imagine to perform rehabilitation exercises or sport-specific tasks without generating actual motor output.

Also known as: Mental practice

Motor imagery training

Classic rehabilitation OTHER

Classic rehabilitation after anterior cruciate ligament reconstruction focusing on regaining mobility, stability and strength of the knee joint and return to sport.

Classic rehabilitation; Motor imagery training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University, Department of Rehabilitation Sciences

Ghent, Belgium

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Erik Witvrouw, Prof. dr.

  Department of Rehabilitation Sciences, Ghent University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sander Denolf

CONTACT

+32498400463; sander.denolf@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 23, 2021
• Study Start: November 15, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

BE (1)