Graded Motor Imagery and Biofeedback in Rotator Cuff Injury

NCT ID: NCT06599567

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-25

Study Completion Date

2025-05-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rotator Cuff Injuries Rotator Cuff Injury Rotator Cuff Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. st group traditional therapy
2. nd group : traditional therapy and graded motor imagery
3. rd group traditional therapy and biofeedback training with nintendo wii
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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Traditional therapy

Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises

Group Type ACTIVE_COMPARATOR

Traditional therapy

Intervention Type OTHER

Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises

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).

Group Type ACTIVE_COMPARATOR

Graded motor imagery

Intervention Type OTHER

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).

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.

Group Type ACTIVE_COMPARATOR

Nintendo Wİİ

Intervention Type OTHER

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.

Interventions

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Traditional therapy

Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises

Intervention Type 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).

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Cansu ERCAN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cansu Ercan

Role: PRINCIPAL_INVESTIGATOR

Unaffiliated"

Locations

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Istanbul University- Cerrahpaşa

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32031724 (View on PubMed)

Hoyek 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.

Reference Type BACKGROUND
PMID: 24575717 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

reference article to see sample size with g power

View Document

Document Type: Study Protocol

View Document

Document Type: Study Protocol

View Document

Related Links

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https://pubmed.ncbi.nlm.nih.gov/24575717/

The therapeutic role of motor imagery on the functional rehabilitation of a stage II shoulder impingement syndrome

https://pubmed.ncbi.nlm.nih.gov/32031724/

Effectiveness of motor imagery and action observation training on musculoskeletal pain intensity: A systematic review and meta-analysis

Other Identifiers

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8Z3KqXp1

Identifier Type: -

Identifier Source: org_study_id

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