NCT06599567

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

September 25, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

September 12, 2024

Last Update Submit

July 28, 2025

Conditions

Keywords

graded motor imagerypainshoulder jointrehabilitationrotator cuff injuries

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 COMPARATOR

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

Other: Traditional therapy

Graded motor imagery

ACTIVE COMPARATOR

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

Nintendo Wİİ

ACTIVE COMPARATOR

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

Interventions

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

Traditional therapy

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).

Graded motor imagery

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.

Nintendo Wİİ

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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: 32031724BACKGROUND
  • 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.

    PMID: 24575717BACKGROUND

Related Links

MeSH Terms

Conditions

Rotator Cuff InjuriesPain

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Cansu Ercan

    Unaffiliated"

    PRINCIPAL INVESTIGATOR

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
Model Details: 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
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

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
November 2024 - November 2025
Access Criteria
Healthcare professionals doing research in this field

Available IPD Datasets

Individual Participant Data Set (sample size)Access
Study Protocol (Nintendo Wii protocol)Access
Study Protocol (Graded motor imagery protocol)Access

Locations