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临床试验/NCT05168033
NCT05168033招募中不适用

The Effect of Motor Imagery as an Additional Tool During the Rehabilitation After Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial

University Ghent1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Visual Analogue Scale (VAS) - Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Visual Analogue Scale (VAS) - Questionnaire

时间窗: 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.

Limb circumference

时间窗: 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

时间窗: 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

时间窗: 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.

Hop tests

时间窗: 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

时间窗: 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.

Knee injury and Osteoarthritis Outcome Score (KOOS) - Questionnaire

时间窗: 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

时间窗: 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.

Knee confidence - Questionnaire

时间窗: 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.

Balance

时间窗: From 8 weeks postoperative until return to sport screening (28 weeks postoperative)

Dynamic balance will be measured using the Y-balance test - lower quadrant

次要结局

  • Penn State Worry Questionnaire (PSWQ) - Questionnaire(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))
  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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