Graded Motor Imagery and Biofeedback in Rotator Cuff Injury

July 28, 2025 updated by: Cansu ERCAN, Istanbul University - Cerrahpasa

THE EFFECT OF GRADED MOTOR IMAGERY AND NINTENDO WII-BASED BIOFEEDBACK TECHNIQUES ON ROTATOR CUFF PATHOLOGIES

Purpose: This study aims to compare the effectiveness of conventional therapy, Graded Motor Imagery (GMI), and Nintendo Wii-based biofeedback therapy in patients with rotator cuff injuries. The goal is to evaluate the impact of these three methods on pain management, range of motion (ROM), patient satisfaction, and functional performance.

Hypotheses:

There is no significant difference in pain management between conventional therapy, GMI, and Wii-based biofeedback therapy.

There is no significant difference in shoulder ROM between the three therapies. There is no significant difference in patient satisfaction among the therapies. There is no significant difference in functional performance improvement between the therapies.

Methods: A randomized, double-blind, controlled trial will be conducted with 36 patients with rotator cuff injuries. They will be randomly assigned to one of three groups and undergo 6 weeks of treatment. Pain, ROM, and functional performance will be assessed pre- and post-treatment. Data will be analyzed using ANOVA.

Potential Outcomes/Significance: The study may show that innovative approaches like GMI and Wii-based biofeedback therapy are effective treatment options. Results could contribute to developing new strategies for treating chronic pain and motor dysfunctions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Title: Comparative Effectiveness of Conventional Therapy, Graded Motor Imagery (GMI), and Nintendo Wii-Based Biofeedback Therapy in Rotator Cuff Injuries

Purpose: The primary aim of this study is to compare the effectiveness of three different therapeutic interventions-conventional therapy, Graded Motor Imagery (GMI), and Nintendo Wii-based biofeedback therapy-in managing rotator cuff injuries. The study will evaluate the impact of these therapies on key outcomes including pain management, shoulder range of motion (ROM), patient satisfaction, and functional performance. By comparing these methods, the study seeks to determine which therapy offers the best overall benefit for patients with rotator cuff injuries.

Hypotheses:

Hypothesis 1: There is no significant difference in pain management between conventional therapy, GMI, and Wii-based biofeedback therapy.

Alternative Hypothesis (H1): Significant differences in pain management exist among these therapies.

Hypothesis 2: There is no significant difference in shoulder ROM between conventional therapy, GMI, and Wii-based biofeedback therapy.

Alternative Hypothesis (H1): Significant differences in shoulder ROM exist among these therapies.

Hypothesis 3: There is no significant difference in patient satisfaction among conventional therapy, GMI, and Wii-based biofeedback therapy.

Alternative Hypothesis (H1): Significant differences in patient satisfaction exist among these therapies.

Hypothesis 4: There is no significant difference in functional performance improvement between conventional therapy, GMI, and Wii-based biofeedback therapy.

Alternative Hypothesis (H1): Significant differences in functional performance improvement exist among these therapies.

Methods: This study will use a randomized, double-blind, controlled trial design. A total of 36 patients diagnosed with rotator cuff injuries will be randomly assigned to one of three treatment groups: conventional therapy, Graded Motor Imagery (GMI), or Nintendo Wii-based biofeedback therapy. Each group will undergo their respective treatment for a duration of 6 weeks. The effectiveness of each treatment will be assessed through measurements taken before and after the intervention. Pain levels, shoulder ROM, and functional performance will be evaluated using standardized assessment tools. Statistical analysis will be performed using ANOVA to compare outcomes across the three treatment groups.

Potential Outcomes/Significance: The results of this study have the potential to highlight the effectiveness of innovative therapies like GMI and Wii-based biofeedback therapy in the treatment of rotator cuff injuries. If these methods are found to be more effective than conventional therapy, they could represent valuable additions to treatment options for patients suffering from chronic pain and motor dysfunctions. The findings may contribute to the development of new, evidence-based strategies for managing rotator cuff injuries and improving patient outcomes in rehabilitation settings.

Study Type

Interventional

Enrollment (Actual)

36

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 Locations

  • Turkey
      • Istanbul, Turkey, 34519
        • Istanbul University- Cerrahpasa

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:

  • Between the ages of 18-65
  • A rotator cuff injury was diagnosed and conservative treatment was decided
  • Volunteer for research
  • People who can read, write and understand Turkish

Exclusion Criteria:

  • Having neurological findings of cervical origin
  • An additional different orthopedic problem in the same shoulder (Full thickness rotator cuff tear, adhesive capsulitis and glenohumeral instability)
  • Uncooperative or mental problem
  • Neurological, vascular and cardiac problem that limits function

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional therapy
Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises
Other: Traditional therapy
Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises
Active Comparator: Graded motor imagery
Cold-Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, graded motor imagery training (body right-left discrimination exercise, imagining the movement and exercising the opposite limb in front of the mirror).
Other: Graded motor imagery
Cold-Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, graded motor imagery training (body right-left discrimination exercise, imagining the movement and exercising the opposite limb in front of the mirror).
Active Comparator: Nintendo Wİİ
Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, games involving your relevant shoulder such as boxing and bowling on the Nintendo Wii game console.
Other: Nintendo Wİİ
Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, games involving your relevant shoulder such as boxing and bowling on the Nintendo Wii game console.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quickDASH short form
Time Frame: From enrollment to the end of treatment at 6 weeks
QuickDASH will be used to assess upper extremity functional limitations and symptoms in patients with rotator cuff injuries Scoring: QuickDASH consists of 11 questions, each rated on a scale from 1 to 5. The final score is calculated between 0 (no difficulty) and 100 (extreme difficulty)
From enrollment to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Pain
Time Frame: From enrollment to the end of treatment at 6 weeks

NPRS (Numeric Pain Rating Scale) is a self-reported scale used to assess the intensity of pain. If you are conducting research on shoulder and arm injuries, such as rotator cuff pathologies, you can use this scale to evaluate the patients' pain levels.

NPRS is an 11-point scale where the patient rates their pain from 0 (no pain) to 10 (worst possible pain)
From enrollment to the end of treatment at 6 weeks
Range of motion
Time Frame: From enrollment to the end of treatment at 6 weeks

ROM (Range of Motion) is an objective measurement used to assess the mobility and flexibility of joints. If you are conducting research on shoulder injuries such as rotator cuff pathologies, you can use ROM assessments to evaluate improvements in joint mobility.

ROM is usually measured in degrees using a goniometer. Specific movements like shoulder flexion, extension, abduction, and rotation are assessed.
From enrollment to the end of treatment at 6 weeks
Kinesiophobia
Time Frame: From enrollment to the end of treatment at 6 weeks

The Tampa Scale of Kinesiophobia (TSK) is a self-reported questionnaire used to assess the fear of movement or re-injury in patients. If you are conducting research on shoulder injuries such as rotator cuff pathologies, you can use this scale to evaluate patients' fear of movement and its impact on recovery.

The TSK consists of 17 items, each rated on a 4-point Likert scale. The total score ranges from 17 to 68, with higher scores indicating greater fear of movement.
From enrollment to the end of treatment at 6 weeks
Global Rating of Change
Time Frame: From enrollment to the end of treatment at 6 weeks

The Global Rating of Change (GRC) is a self-reported scale used to measure a patient's perception of overall improvement or deterioration over time. If you are conducting research on rotator cuff injuries, you can use the GRC to evaluate patients' subjective assessment of their progress.

The GRC is typically measured on a scale ranging from -5 (a very great deal worse) to +5 (a very great deal better), with 0 indicating no change.
From enrollment to the end of treatment at 6 weeks
Lateralization
Time Frame: From enrollment to the end of treatment at 6 weeks
The Recognise app is a tool used to assess lateralization, which involves identifying left and right body parts to measure motor imagery and cortical representation. If you are conducting research on rotator cuff injuries, you can use this app to evaluate patients' ability to recognize and distinguish between left and right body parts, which can be important in assessing changes in cortical representation and motor imagery.
From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

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

Sponsor

Istanbul University - Cerrahpasa

Investigators

  • Principal Investigator: Cansu Ercan, Unaffiliated"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

September 25, 2024

Primary Completion (Actual)

May 25, 2025

Study Completion (Actual)

May 25, 2025

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8Z3KqXp1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

November 2024 - November 2025

IPD Sharing Access Criteria

Healthcare professionals doing research in this field

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: sample size
    Information comments: reference article to see sample size with g power
  2. Study Protocol
    Information identifier: Nintendo Wii protocol
  3. Study Protocol
    Information identifier: Graded motor imagery protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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