Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair?

NCT05670080 | Suspended DMC

• 1 other identifier: MIafterARCR
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Tears; Motor Imagery; Muscle Activity; Atrophy, Muscular; Patient Satisfaction; Kinesiophobia; Shoulder Pain

Keywords

Motor Imagery; Muscle Activity; Muscular Atrophy; Rotator Cuff Tears

Outcome Measures

Primary Outcomes (5)

• Change of Muscle activity

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

  1 week before surgery and week 8 after surgery

• Change of shoulder functional level

  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.

  1 week before surgery and week 8 after surgery

• Change of Kinesthetic and visual imagery levels

  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).

  1 week before surgery and week 8 after surgery

• Change of Kinesiophobia

  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).

  1 week before surgery and week 8 after surgery

• Change of Patient Satisfaction

  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.

  1 week before surgery and week 8 after surgery

Secondary Outcomes (4)

• 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

• Change in muscle atrophy

  1 week before surgery and week 8 after surgery

Study Arms (2)

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.

Behavioral: Motor Imagery; Behavioral: Physical Therapy

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.

Behavioral: Physical Therapy

Interventions

Motor Imagery BEHAVIORAL

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 Motor Imagery (MI) Group

Physical Therapy BEHAVIORAL

Electrotherapy (TENS), cold pack therapy, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder.

Physical Therapy (PT) Group; The Motor Imagery (MI) Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alanya Alaaddin Keykubat University: lead
• Pamukkale University: collaborator
• Alanya Allaaddin Keykubat University Hospital: collaborator
• Alanya Hamdullah Emin Pasha University: collaborator

Study Sites (1)

Alanya Alaaddin Keykubat University

Alanya, Antalya, Turkey (Türkiye)

Location

Related Publications (8)

• Araya-Quintanilla F, Gutierrez-Espinoza H, Jesus Munoz-Yanez M, Rubio-Oyarzun D, Cavero-Redondo I, Martinez-Vizcaino V, Alvarez-Bueno C. The Short-term Effect of Graded Motor Imagery on the Affective Components of Pain in Subjects with Chronic Shoulder Pain Syndrome: Open-Label Single-Arm Prospective Study. Pain Med. 2020 Oct 1;21(10):2496-2501. doi: 10.1093/pm/pnz364.

  PMID: 32003812 BACKGROUND

• Guillot A, Collet C, Nguyen VA, Malouin F, Richards C, Doyon J. Brain activity during visual versus kinesthetic imagery: an fMRI study. Hum Brain Mapp. 2009 Jul;30(7):2157-72. doi: 10.1002/hbm.20658.

  PMID: 18819106 BACKGROUND

• Boden-Albala B, Roberts ET, Bazil C, Moon Y, Elkind MS, Rundek T, Paik MC, Sacco RL. Daytime sleepiness and risk of stroke and vascular disease: findings from the Northern Manhattan Study (NOMAS). Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):500-7. doi: 10.1161/CIRCOUTCOMES.111.963801. Epub 2012 Jul 10.

  PMID: 22787063 BACKGROUND

• Chholak P, Niso G, Maksimenko VA, Kurkin SA, Frolov NS, Pitsik EN, Hramov AE, Pisarchik AN. Visual and kinesthetic modes affect motor imagery classification in untrained subjects. Sci Rep. 2019 Jul 8;9(1):9838. doi: 10.1038/s41598-019-46310-9.

  PMID: 31285468 BACKGROUND

• Hayes K, Walton JR, Szomor ZR, Murrell GA. Reliability of five methods for assessing shoulder range of motion. Aust J Physiother. 2001;47(4):289-94. doi: 10.1016/s0004-9514(14)60274-9.

  PMID: 11722295 BACKGROUND

• Matlak S, Andrews A, Looney A, Tepper KB. Postoperative Rehabilitation of Rotator Cuff Repair: A Systematic Review. Sports Med Arthrosc Rev. 2021 Jun 1;29(2):119-129. doi: 10.1097/JSA.0000000000000310.

  PMID: 33972488 BACKGROUND

• Opsommer E, Chevalley O, Korogod N. Motor imagery for pain and motor function after spinal cord injury: a systematic review. Spinal Cord. 2020 Mar;58(3):262-274. doi: 10.1038/s41393-019-0390-1. Epub 2019 Dec 13.

  PMID: 31836873 BACKGROUND

• Herrador Colmenero L, Perez Marmol JM, Marti-Garcia C, Querol Zaldivar MLA, Tapia Haro RM, Castro Sanchez AM, Aguilar-Ferrandiz ME. Effectiveness of mirror therapy, motor imagery, and virtual feedback on phantom limb pain following amputation: A systematic review. Prosthet Orthot Int. 2018 Jun;42(3):288-298. doi: 10.1177/0309364617740230. Epub 2017 Nov 20.

  PMID: 29153043 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Muscular Atrophy; Patient Satisfaction; Kinesiophobia; Shoulder Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Phobic Disorders; Anxiety Disorders; Mental Disorders; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Özüm ÇETİNKAYA EREN, PT, MSc

  Alanya Alaaddin Keykubat University

  PRINCIPAL INVESTIGATOR

• Ummuhan BAŞ ASLAN, Prof.Dr.PT.

  Pamukkale University

  STUDY DIRECTOR

• Kazım Emre EREN, PT, MSc

  Alanya Alaaddin Keykubat University Hospital

  STUDY CHAIR

• Anıl GÜLCÜ, Asst.Prof.Dr

  Alanya Alaaddin Keykubat University

  STUDY CHAIR

• Erdem DEMİR, Asst.Prof.Dr

  Alanya Hamdullah Emin Paşa University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will be divided into two parallel groups: the MI group and the Control group. Both groups will participate in a routine physical therapy program after 4 weeks of immobilization, with the MI group receiving additional motor imagery training during the preoperative period. MI training will be provided to Group 1 participants who are planning for rotator cuff repair in the pre-surgical period by the corresponding researcher. The physical therapy program will be applied by a physiotherapist with a master's degree and 8 years of professional experience in the field of orthopedic rehabilitation, who is different from the corresponding researcher of the study.

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: January 4, 2023
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)