Comparison of Rehabilitative Game Exercise and Body Awareness Therapy in Rotator Cuff Syndrome

NCT06228625 | Recruiting

• 1 other identifier: IMUogorgulugoksu1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Rotator cuff syndrome is one of the most common problems in the shoulder, starting as acute tendinopathy and progressing to partial and full thickness tears. Shoulder pain causes a decrease in shoulder joint movement, joint position sense, upper extremity function and quality of life. Among the most commonly used conservative treatment methods; Joint range of motion exercises, stretching exercises, strengthening exercises, mobilization and electrotherapy method are included. Nowadays, with the widespread use of technology in rehabilitation, video-based games have begun to be used for rehabilitative purposes in addition to conservative approaches. Although the effectiveness of video-based games has been extensively studied in diseases such as cerebral palsy, stroke and parkinsonism, there are a limited number of studies in the field of orthopedic rehabilitation, especially in shoulder rehabilitation. Basic body awareness therapy is used to treat chronic musculoskeletal-related painful conditions. In the literature, basic body awareness therapy has been studied in patient groups such as mental health, stroke patient groups, chronic musculoskeletal problems, chronic waist and neck pain, scoliosis and knee osteoarthritis. Studies have shown that the TBFT method provides improvements in individuals' body awareness, mobility in daily living activities, health-related quality of life, body image and pain intensity. However, no studies have been found in which basic body awareness therapy was used in the field of shoulder rehabilitation. Our study aims to compare the effectiveness of a rehabilitative game exercise program and body awareness training in terms of pain, joint range of motion, shoulder functionality, proprioception, body awareness, shoulder-related quality of life, kinesiophobia and patient satisfaction in individuals with Rotator cuff syndrome.

Conditions

Rotator Cuff Syndrome

Keywords

Body Awareness; Body İmage; Exergame; Rotator cuff; Videogames

Outcome Measures

Primary Outcomes (4)

• Pain Severity rated their feelings of pain on the line by themselves, thereby quantifying the pain.sual Analogue Scale

  Participants pain intensities ranged from "0" (no pain) to "10" (unbearable pain) to 10 cm will be evaluated with the Visual Pain Scale. The pain intensity of the participants before and after the treatment was evaluated at rest and during activity.

  Baseline and after 6 weeks

• Pain threshold

  Algometer is a device used to evaluate the pain threshold, thanks to the pressure it applies. While increasing the pressure using the algometer, persons are asked to indicate at the first point where they feel pain or discomfort. The first point of discomfort is defined as the pain threshold of the individual.The first point of discomfort is defined as the individual's pain threshold point. When evaluating the pain thresholds of people participating in the study, their most sensitive areas will be taken as reference. Measurements will be repeated 3 times and their average will be taken.

  Baseline and after 6 weeks

• Evaluation of joint range of motion

  Baseline digital Absolute + Axis goniometer device will be used. Flexion, extension, abduction, internal and external rotation range of motion of the shoulder joint will be evaluated in degrees. For each joint range of motion value, 3 consecutive measurements will be taken and the average value will be recorded.

  Baseline and after 6 weeks

• Evaluation of Joint Position Sense

  Active angle repetition test for shoulder joint position sense will be performed with the smartphone goniometer application. 40° and 100° elevation angles will be used in the scapular plan, which are frequently preferred in the literature. For the evaluation, first of all, the participants will be asked to passively perform a 40° elevation movement on one shoulder in the scapular plane while their eyes are open and they will be asked to learn this angle. Then, the participants will raise their shoulders to 40° elevation 3 more times with their eyes closed, wait 10 seconds to teach this angle, and then return to the starting position.The test will be repeated 6 times and individuals will rest for 5 seconds between each repetition. All applications were repeated for a shoulder elevation angle of 100°. The test was performed at 40° and 100° shoulder elevation on both shoulders.

  Baseline and after 6 weeks

Secondary Outcomes (6)

• Rotator Cuff Quality of Life

  Baseline and after 6 weeks

• American Shoulder and Elbow Surgeons (ASES)

  Baseline and after 6 weeks

• Body Awareness Questionnaire

  Baseline and after 6 weeks

• Body Image Survey (BIA)

  Baseline and after 6 weeks

• The Tampa Scale for Kinesiophobia (TSK)

  Baseline and after 6 weeks

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Conventional exercise training will be given to the control group for 6 weeks, 5 days a week, for 45 minutes. Conventional exercises will be applied to this group under the supervision of a physiotherapist for 5 days in our unit.

Behavioral: Conventional Exercise Group

Body Awareness Training Group

EXPERIMENTAL

After the first evaluation, the training group will be given basic body awareness exercise training for 6 weeks, 2 days a week, for 45 minutes. This group will be given to basic body awareness exercises under the supervision of a physiotherapist for 2 days in our unit. Individuals in this group will be applied basic body awareness exercisea program in addition to conventional exercises.

Behavioral: Body Awareness Training Group

Rehabilitative Game Exercise Group

EXPERIMENTAL

Individuals in this group will be applied a video-based rehabilitative game exercise program in addition to conventional exercises. A digital game network called 'Active Arcade Game' will be used for rehabilitative game exercises. Rehabilitative Game Exercise Group for 6 weeks, 2 days a week, for 45 minutes. This group will be given to basic body awareness exercises under the supervision of a physiotherapist for 2 days in our unit.

Behavioral: Rehabilitative Game Exercise Group

Interventions

Conventional Exercise Group BEHAVIORAL

* Wand Exercises (Shoulder flexion, abduction, extension, external, internal rotation \*10 rep.) * Codmann Exercises (In each direction with front-back, right-left, clockwise and counterclockwise movements \*10 rep.) * Finger Ladder (flexion and abduction directions \* 10 rep.) * Strengthening Exercises (Shoulder flexion, abduction, extension, external, internal rotation \*10 rep). * Posterior, anterior and inferior capsule stretching ,pectoral muscle stretching \* 10 rep.

Control Group

Body Awareness Training Group BEHAVIORAL

* Supine: Body scan, contraction-relaxation exercises, strength recovery exercises combined with sound, stretching exercises, cross and star stretching. * Sitting: Teaching the correct body alignment while sitting, exercise to restore the correct body alignment, * Standing: Weight bearing exercises within stability limits, midline descent and elevation exercises, midline rotation exercises, wave motion, pushing movement combined with oblique weight bearing.

Body Awareness Training Group

Rehabilitative Game Exercise Group BEHAVIORAL

* Cone Knockout: The game requires touching the cones that appear alternately on the right and left within one minute. * Space Pong: It is required to play by hitting the ball with the right or left hand. It requires only upper extremity use and has seven abductions. Scoring is based on the ball hit. * Reaction: It is a game that requires touching the green dots that appear on the screen within a certain period. The points received vary depending on the speed of touching the dots. Points are lost when the red dots are touched. * Whack A Male: The player has 3 rights, and it requires using the upper extremity to hit the moles that come out of 5 holes at different times. A mole with a thorn on its head and a bomb should not be hit. Before the spiny mole emerges, a red light appears in the hole where it will emerge.

Rehabilitative Game Exercise Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of partial supraspinatus rupture by an Orthopedics and Traumatology specialist placement.
• Unilateral shoulder pain,
• Not having been involved in any physiotherapy program before due to shoulder problem,
• Body mass index (BMI) ≤ 30 kg/m²
• Cooperation of individuals

You may not qualify if:

• Having had previous shoulder surgery,
• Having received local corticosteroid injection/corticosteroid treatment in the last three months,
• Presence of a disease that will affect the neurological, cardiac, systemic, cognitive and visual systems,

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Özlem Görgülü Göksu

Istanbul, Beykoz, 34815, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Özlem Görgülü Göksu, PT, MSc

CONTACT

+905386301995; ozlemgrgl94@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist,Master of Science (M.Sc.)

Model Details: Randomize Controlled Double Blind Study

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 29, 2024
• Study Start: December 2, 2024
• Primary Completion: December 2, 2025
• Study Completion: December 2, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)