Clinical trial NCT06599567: Motor Imagery and Wii-Based Biofeedback for Rotator Cuff Injuries
Official title: The Effect of Graded Motor Imagery and Nintendo Wii- Based Biofeedback Techniques on Rotator Cuff Pathologies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rotator Cuff Injuries
Rotator Cuff Injury
Rotator Cuff Syndrome
Keywords: rotator cuff
graded motor imagery
nintendo wii
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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 30 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: 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 30 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.

Eligibility criteria: 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

Primary outcomes:
measure: quickDASH short form
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
measure: Shoulder Pain
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Range of motion
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Kinesiophobia
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Global Rating of Change
timeFrame: From enrollment to the end of treatment at 6 weeks
measure: Lateralization
timeFrame: From enrollment to the end of treatment at 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpaşa
Study officials:
affiliation: Unaffiliated&amp;amp;amp;amp;amp;amp;amp;amp;amp;#34;
name: Cansu Ercan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.