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临床试验/NCT03473821
NCT03473821进行中(未招募)不适用

Motor Imagery to Facilitate Sensorimotor Relearning (MOTIFS) After ACL Injury: A Randomized Controlled Trial

Lund University2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2018年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
106
试验地点
2
主要终点
Anterior Cruciate Ligament Return to Sport After Injury Scale

研究概览

简要总结

Anterior cruciate ligament injury is a common issue in sports involving cutting and jumping. Treatment may include surgical intervention followed by physical therapy, or no surgical intervention with the main treatment being physical therapy. Despite meeting physical therapist requirements for return to sport, many athletes do not return to sport. This discrepancy in the physical requirements for returning to physical activity and actually returning to the same physical activity level leads to the question of whether current rehabilitation treatments may be improved upon.

One potential method is by integrating mental training into physical rehabilitation. By using mental training and increasing the meaning and relevance of rehabilitation, a person may be preparing more effectively for return to the pace and intensity common during physical activity.

In this study, the investigators aim to create and evaluate a model of training which incorporates physical activity-related movement and mental training in order to more effectively prepare people for return to physical activity after anterior cruciate ligament injury. This will be measured by examining functional hop measures, as well as patient-reported outcomes.

详细描述

Anterior Cruciate Ligament (ACL) injury is increasingly common in sports involving jumping and cutting. Treatment for such injuries most often includes physical therapist-supervised rehabilitation, with or without surgical reconstruction. Care-as-usual rehabilitation often includes neuromuscular training in order to improve function and reduce knee-related symptoms. Recent data shows that 90% of athletes undergoing rehabilitation achieved normal or nearly-normal knee function when measured in strength and knee laxity. Despite this number, 56% of these athletes did not return to sport or pre-injury activity levels. Due to this imbalance, the question is raised of whether there is a potential to supplement care-as-usual in order to improve upon current rehabilitative training programs.

One attractive alternative is the use of dynamic motor imagery (DMI), which is a form of mental training intended to increase functional equivalence. This is done by imaging an activity-specific and relevant movement while simultaneously completing a similar movement, thereby simulating a real-life physical activity movement. This approach makes it possible to create a situation in which a person is able to create meaning and find relevance in movement used in a rehabilitative training environment.

In this study, the investigators aim to create and test a new training model, referred to as MOTor Imagery to Facilitate Sensorimotor re-learning (MOTIFS), and compare the efficacy of neuromuscular training plus dynamic motor imagery vs neuromuscular training alone in terms of muscle function and patient-reported outcomes in people with an ACL injury and with a goal of returning to pre-injury level of activity.

Primary Hypothesis: 12 weeks of neuromuscular training plus dynamic motor imagery will improve muscle function, measured by relative change in hop performance in the injured leg in side hop test, and patient-reported measures of psychological readiness to return to sport to a greater extent and with a quicker onset of recovery than neuromuscular training alone.

Methods:

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 (Outcomes Assessor)

盲法说明

The outcomes assessor will be blinded, but due to the nature of the study, neither the primary investigator, participant, nor the care providers can be blinded

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women
  • Over the age of 16
  • Traumatic knee injury with or without surgical intervention, and involving one or more knee structures
  • Currently undergoing physical therapist-supervised rehabilitation and have reached the stage in rehabilitation which includes single-leg hop training (i.e. able to complete a side hop and a single-leg hop for distance)
  • Active before the injury in recreational or competitive physical activity, with a goal of returning to physical activity

排除标准

  • Any degenerative knee disorder, or other disease or disorder overriding the knee injury (e.g. spine disorder, neurological disease)
  • Have reached end-stage rehabilitation (i.e. have undergone return to activity evaluation by their physical therapist) or is estimated to return less than 12 weeks from inclusion date
  • Do not understand the languages of interest (Swedish, Danish, Norwegian), or English

结局指标

主要结局

Anterior Cruciate Ligament Return to Sport After Injury Scale

时间窗: 12 months

12 question self-reported outcome scale measuring readiness to return to sport. Scale ranges from 0-10 for each question. Scores summed from 0 (worst) - 100 (best).

Side Hop

时间窗: 12 weeks

Change in hop performance on the injured leg from baseline to 12 weeks, expressed in number of hops completed

次要结局

  • Test Battery to Assess Postural Orientation During Functional Tasks(12 weeks)
  • Hop Test Battery(12 weeks)
  • Knee Injury and Osteoarthritis Outcome Score(12 weeks; 12 month follow-up)
  • Rehabilitation Outcome Satisfaction(12 months; 12 month follow-up)
  • Perceived Stress Scale(12 weeks; 12 month follow-up)
  • Motivation(12 weeks; 12 month follow-up)
  • Physical Activity Enjoyment Scale(12 weeks; 12 month follow-up)
  • Patient Enablement Instrument(12 weeks)
  • Compliance to intervention in minutes(12 weeks)
  • Tegner Activity Scale(12 months)
  • Phenomenological Interview(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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