Graded Motor Imagery and Biofeedback in Rotator Cuff Injury
THE EFFECT OF GRADED MOTOR IMAGERY AND NINTENDO WII-BASED BIOFEEDBACK TECHNIQUES ON ROTATOR CUFF PATHOLOGIES
1 other identifier
interventional
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
September 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2025
CompletedJuly 30, 2025
July 1, 2025
8 months
September 12, 2024
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
quickDASH short form
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 Outcomes (5)
Shoulder Pain
From enrollment to the end of treatment at 6 weeks
Range of motion
From enrollment to the end of treatment at 6 weeks
Kinesiophobia
From enrollment to the end of treatment at 6 weeks
Global Rating of Change
From enrollment to the end of treatment at 6 weeks
Lateralization
From enrollment to the end of treatment at 6 weeks
Study Arms (3)
Traditional therapy
ACTIVE COMPARATORCold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises
Graded motor imagery
ACTIVE COMPARATORCold-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).
Nintendo Wİİ
ACTIVE COMPARATORCold - 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.
Interventions
Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University- Cerrahpaşa
Istanbul, Istanbul, 34519, Turkey (Türkiye)
Related Publications (2)
Suso-Marti L, La Touche R, Angulo-Diaz-Parreno S, Cuenca-Martinez F. Effectiveness of motor imagery and action observation training on musculoskeletal pain intensity: A systematic review and meta-analysis. Eur J Pain. 2020 May;24(5):886-901. doi: 10.1002/ejp.1540. Epub 2020 Feb 20.
PMID: 32031724BACKGROUNDHoyek N, Di Rienzo F, Collet C, Hoyek F, Guillot A. The therapeutic role of motor imagery on the functional rehabilitation of a stage II shoulder impingement syndrome. Disabil Rehabil. 2014;36(13):1113-9. doi: 10.3109/09638288.2013.833309. Epub 2014 Feb 28.
PMID: 24575717BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cansu Ercan
Unaffiliated"
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Patients will not know which group they belong to and the physiotherapist who makes the evaluations will not know which treatment the patients receive. Our study will be conducted in a double-blind manner.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 12, 2024
First Posted
September 19, 2024
Study Start
September 25, 2024
Primary Completion
May 25, 2025
Study Completion
May 25, 2025
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- November 2024 - November 2025
- Access Criteria
- Healthcare professionals doing research in this field
All collected IPD, all IPD that underlie results in a publication