跳至主要内容
临床试验/NCT05670080
NCT05670080暂停不适用

Does Motor Imagination Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? Randomized Controlled, Single-Blind Trial

Alanya Alaaddin Keykubat University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
36
试验地点
1
主要终点
Change of Muscle activity

研究概览

简要总结

Objective: The aim of this study is to investigate the effect of motor imagery on muscle activity, pain, and function in arthroscopic rotator cuff repair.

Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2 groups, each with at least 18 participants: Group 1 (MI group) and Group 2 (Control group) (Randomizer.org). Both groups will receive a 4-week physical therapy program. MI (Motor Imagination) group will receive a motor imagination program in addition to the physical therapy program. Data will collect using the visual analog scale (VAS), goniometric measurement, circumference measurement, Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), Kinesthetic and Visual Imagery Questionnaire- KVIQ-20, Tampa Kinesiophobia Scale, 3-question satisfaction questionnaire, superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT).

Practice Implications: The current study will contribute to understanding how motor imagination affects muscle activity and muscle atrophy.

详细描述

After shoulder trauma, the rotator cuff may sustain tears of varying degrees. Degenerative rotator cuff tears are an important cause of shoulder pain and dysfunction. Rotator cuff injuries can be treated conservatively, medically, and surgically. Surgical treatment can be performed as arthroscopic-assisted mini-open or full arthroscopic techniques. After rotator cuff repair, long-term immobilization can lead to complications of scar formation and related shoulder stiffness, pain, muscle/tendon atrophy, and delayed return to functional and occupational activities. Motor imagery (MI) can be used in cases that cause immobilization such as pain, fatigue, and loss of strength during and after injury, or in cases of limited access to healthcare facilities.

Motor imagery is the imagining of action without its physical execution and motor imagery elicits activity in brain regions that are normally activated during actual task performance. The brain perceives real experiences and the visualization process as similar. For this reason, imagery is considered a mental exercise. The functional equivalence hypothesis shows that there is a great deal of overlap between the neural substrates of physical and imagined movement execution.

In a study examining brain signals during magnetoencephalographic (MEG) evaluation and motor movements, it was stated that the primary motor (less than motor activity) and posterior parietal cortex were activated during MI.

Today, the majority of mental exercise studies are carried out in the field of neurological rehabilitation. There are many studies on stroke, multiple sclerosis, Parkinson's, spinal cord injury, and phantom pain. MI is an effective method for motor learning that is also used in orthopedics and sports. The MI application may be an appropriate tool for professional athletes to maintain and improve their physical performance capacity. In a systematic review of the effect of MI on pain and motor function after spinal cord injury, the majority of the findings confirmed the benefits of MI interventions on the motor function when used concurrently with physical exercises. According to the findings of the systematic review published by Colmenero et al., MI has positive effects on phantom pain. Studies in patients with chronic shoulder pain syndrome and subacromial impingement syndrome have reported positive effects of MI on pain and shoulder function and active range of motion. Significantly positive results were observed in pain and disability scores after the 4th week with MI application in rotator cuff patients. Significantly positive results were observed in pain and disability scores after the 4th week of MI application in rotator cuff patients. In conclusion, extensive experimental research indicates that MI is a valuable and cost-effective technique for improving engine performance and recovery. There has been no research into the effectiveness of MI after rotator cuff repair.

The aim of this study is to investigate the effect of motor imagery on muscle activity, pain, and function in arthroscopic rotator cuff repair.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

盲法说明

A physiotherapist with a master's degree who is unaware of the study's content will apply the physical therapy program and assessments.

Participants will take physical therapy program and MI training without being told which group they were in.

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to speak and understand Turkish - Previous arthroscopic rotator cuff repair
  • Achieving a minimum of 40 points on the Kinesthetic and Visual Imagery Questionnaire -20 (KGIA-20)
  • Access to adequate technological devices for communication and follow-up

排除标准

  • Who with neurological diseases that may cause functional impairment.
  • Patients who have another shoulder problem and/or have had previous shoulder surgery on the same upper extremity.
  • Who wanted to leave the study at their own request
  • Who could not continue to work due to any additional discomfort developed

研究组 & 干预措施

Physical Therapy (PT) Group

Experimental

Following the preoperative evaluations, both groups will be shown remedial exercises (pumping exercises that activate the circulation), flexion, and extension wrist exercises, which they should do for four weeks.

After a 4-week immobilization period, participants in the PT Group will begin a physical therapy program that includes routine electrotherapy (TENS), cold pack therapy, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder.

干预措施: Physical Therapy (Behavioral)

The Motor Imagery (MI) Group

Experimental

MI training will be prepared using the Microsoft PowerPoint program which includes written, visual and audio materials, as well as features that can be sent to participants ' phones/tablets/computers. The MI training will allow the participant to perform visual and kinesthetic imagery with visual and audible notifications and will include 6 exercises for the muscles around the shoulder, 3 exercises for strengthening, and dynamic stabilization for the muscles around the scapula. In each presentation, verbal cues will be given to explain how to imagine the movement while a visual of the motor movement is displayed on the screen. During MI exercises, participants will be called once a week and their MI practices will be followed up.

After the first four weeks of MI training, the MI group will also participate in a four-week physical therapy program.

干预措施: Motor Imagery (Behavioral)

The Motor Imagery (MI) Group

Experimental

MI training will be prepared using the Microsoft PowerPoint program which includes written, visual and audio materials, as well as features that can be sent to participants ' phones/tablets/computers. The MI training will allow the participant to perform visual and kinesthetic imagery with visual and audible notifications and will include 6 exercises for the muscles around the shoulder, 3 exercises for strengthening, and dynamic stabilization for the muscles around the scapula. In each presentation, verbal cues will be given to explain how to imagine the movement while a visual of the motor movement is displayed on the screen. During MI exercises, participants will be called once a week and their MI practices will be followed up.

After the first four weeks of MI training, the MI group will also participate in a four-week physical therapy program.

干预措施: Physical Therapy (Behavioral)

结局指标

主要结局

Change of Muscle activity

时间窗: 1 week before surgery and week 8 after surgery

Change of Muscle activity will be evaluated with superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT).

Change of Kinesthetic and visual imagery levels

时间窗: 1 week before surgery and week 8 after surgery

The Kinesthetic and Visual Imagery Questionnaire- KVIQ-20 will be used to assess the kinesthetic and visual imagery levels of healthy and physically disabled individuals.The questionnaire contains a total of 20 titles, 10 of which are visual and 10 of which are kinesthetic. The intensity level of imagery is recorded on a 5-point Likert scale with the questionnaire (5 = appearance of a live image; 1 = no image or sensation).

Change of Kinesiophobia

时间窗: 1 week before surgery and week 8 after surgery

Kinesiophobia was evaluated with Tampa Scale of Kinesiophobia (TSK).TSK is a 17-question checklist. The scale employs a 4-point Likert scoring system (1= strongly disagree, 4= completely agree).

Change of shoulder functional level

时间窗: 1 week before surgery and week 8 after surgery

Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) will be used to determine the upper extremity functional level.The total of all item scores was then used to calculate the interrogation score, which ranged from 0 (no disability) to 100. (most severe disability). The first 20 questions concern physical competence, while the last ten concern pain and functional and environmental limitations.

Change of Patient Satisfaction

时间窗: 1 week before surgery and week 8 after surgery

A Numerical Evaluation Scale will be used to evaluate a 2-question satisfaction questionnaire. This scale is made up of a horizontal straight line 10 cm long. The line has a value of 0 at the start and a value of 10 at the end, from left to right. On a scale of 0 to 10, patients will be asked to rate their level of satisfaction.

次要结局

  • Change in muscle atrophy(1 week before surgery and week 8 after surgery)
  • Descriptive Information(1 week before surgery)
  • Change in Pain-Visual analog scale(1 week before surgery, week 4 and week 8 after surgery)
  • Change of Range of Motion(1 week before surgery, week 4 and week 8 after surgery)

研究者

发起方
Alanya Alaaddin Keykubat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ozum Cetinkaya

Principal Investigator

Alanya Alaaddin Keykubat University

研究点 (1)

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