- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07481864
The Effect of Early-Phase Graded Motor Imagery Following Massive Rotator Cuff Repair.
March 16, 2026 updated by: 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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
38
Phase
- 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
- Name: Nuray ALACA
- Phone Number: 05324251290
- Email: nuray.alaca@acibadem.edu.tr
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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
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 (Estimated)
August 15, 2026
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
October 30, 2026
Study Registration Dates
First Submitted
March 16, 2026
First Submitted That Met QC Criteria
March 16, 2026
First Posted (Actual)
March 19, 2026
Study Record Updates
Last Update Posted (Actual)
March 19, 2026
Last Update Submitted That Met QC Criteria
March 16, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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