The Effect of Early-Phase Graded Motor Imagery Following Massive Rotator Cuff Repair.

July 14, 2026 updated by: Nuray Alaca, Acibadem University

The Effect of Early-Phase Graded Motor Imagery Following Massive Rotator Cuff Repair

Massive rotator cuff tears are associated with significant pain, functional limitations, and prolonged rehabilitation following surgical repair. In the early postoperative phase, rehabilitation protocols are often limited due to surgical protection requirements, which may delay the restoration of motor control and shoulder function. Graded motor imagery (GMI), a movement representation technique that includes laterality recognition, motor imagery, and mirror therapy, has been shown to modulate cortical processing and improve pain and motor function in various musculoskeletal and neurological conditions. However, its potential role in early postoperative shoulder rehabilitation has not been adequately investigated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 30 and 65 years
  • Presence of an arthroscopically repaired anterior-superior rotator cuff tear, involving the supraspinatus and subscapularis tendons

Exclusion Criteria:

  • Age younger than 30 years or older than 65 years

    • Presence of severe malignant, hematological, endocrine, metabolic, rheumatologic, or gastrointestinal diseases
    • Diagnosis of glenohumeral osteoarthritis (Kellgren-Lawrence grade III or higher, with radiographic evidence of osteophytes)
    • Current treatment with cytotoxic agents or systemic corticosteroids
    • Alcohol dependence, history of substance abuse, or psychological/emotional disorders that may compromise the validity of informed consent
    • Previous surgery on the ipsilateral shoulder
    • Multiple tendon tears, such as combined tears involving the supraspinatus together with the infraspinatus or subscapularis tendons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional Rehabilitation Program
Participants will receive a conventional postoperative rehabilitation program following massive rotator cuff repair. The program will include standard physiotherapy interventions such as protected passive range-of-motion exercises, gradual progression to active-assisted and active exercises, scapular stabilization exercises, and pain management strategies according to the early postoperative rehabilitation protocol.
Other: Graded Motor İmagery
The graded motor imagery program will include laterality recognition training, motor imagery exercises, and mirror therapy tasks aimed at activating cortical motor networks without physical shoulder movement during the early postoperative phase.
Experimental: Graded motor imagery
Participants in the experimental group will receive the conventional rehabilitation program in addition to a graded motor imagery intervention. The graded motor imagery program will include laterality recognition training, motor imagery exercises, and mirror therapy tasks aimed at activating cortical motor networks without physical shoulder movement during the early postoperative phase.
Other: Graded Motor İmagery
The graded motor imagery program will include laterality recognition training, motor imagery exercises, and mirror therapy tasks aimed at activating cortical motor networks without physical shoulder movement during the early postoperative phase.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity (Numeric Rating Scale, NRS)
Time Frame: Baseline (postoperative day 0), 2 weeks, 4 weeks, 6 weeks, and 12 weeks after surgery.
Pain intensity will be assessed using the Numeric Rating Scale (NRS), where participants rate their average shoulder pain over the past 24 hours on a scale from 0 (no pain) to 10 (worst imaginable pain). Pain will be evaluated at rest, during activity, and at night.
Baseline (postoperative day 0), 2 weeks, 4 weeks, 6 weeks, and 12 weeks after surgery.
Subjective Shoulder Value (SSV)
Time Frame: Baseline (postoperative day 0), 2 weeks, 4 weeks, 6 weeks, and 12 weeks.
Participants will rate the overall function of their shoulder on a 10-cm scale ranging from "as bad as it could be" to "as good as it could be."
Baseline (postoperative day 0), 2 weeks, 4 weeks, 6 weeks, and 12 weeks.
Passive Shoulder Range of Motion
Time Frame: 4 weeks, 6 weeks, and 12 weeks after surgery.
Passive shoulder range of motion will be measured using a goniometer.
4 weeks, 6 weeks, and 12 weeks after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index (SPADI)
Time Frame: 6 weeks and 12 weeks after surgery.
The Shoulder Pain and Disability Index (SPADI) is a self-reported questionnaire consisting of pain (5 items) and disability (8 items) subscales. Scores range from 0 to 100, with higher scores indicating greater pain and functional limitation.
6 weeks and 12 weeks after surgery.
Motor Imagery Ability (VMIQ-2)
Time Frame: Baseline (postoperative day 0), 6 weeks, and 12 weeks.
Motor imagery ability will be evaluated using the Vividness of Movement Imagery Questionnaire-2 (VMIQ-2), which assesses internal visual imagery, external visual imagery, and kinesthetic imagery across 36 items. Lower scores indicate more vivid imagery ability.
Baseline (postoperative day 0), 6 weeks, and 12 weeks.
Tampa Scale of Kinesiophobia (TSK)
Time Frame: Baseline (postoperative day 0), 6 weeks, and 12 weeks.
The Tampa Scale of Kinesiophobia evaluates fear of movement related to pain. Scores range from 17 to 68, with higher scores indicating greater fear of movement.
Baseline (postoperative day 0), 6 weeks, and 12 weeks.
Pain Catastrophizing Scale (PCS)
Time Frame: Baseline (postoperative day 0), 6 weeks, and 12 weeks.
The PCS assesses catastrophic thinking related to pain across 13 items. Total scores range from 0 to 52, with higher scores indicating greater catastrophizing.
Baseline (postoperative day 0), 6 weeks, and 12 weeks.
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame: Baseline (postoperative day 0), 6 weeks, and 12 weeks.
The PSEQ measures confidence in performing activities despite pain. Scores range from 0 to 60, with higher scores indicating greater self-efficacy.
Baseline (postoperative day 0), 6 weeks, and 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acibadem University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-10-384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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