The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis

NCT06201325 | Recruiting

• 1 other identifier: 2023-19/146
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effectiveness of virtual reality based exercises and conventional physical therapy on shoulder pain, mobility, functional ability and quality of life in adhesive capsulitis and to investigate whether it is superior to the control group.

Conditions

Adhesive Capsulitis

Keywords

adhesive capsulitis; virtual reality; conventional physical therapy

Outcome Measures

Primary Outcomes (6)

• Visual analog scale

  The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale

  0( baseline)

• Visual analog scale

  The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale

  3th week

• Visual analog scale

  The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale

  12th week

• Range of Motion

  Shoulder ROM is measured using a universal protractor(goniometer). Shoulder flection, extension, abduction, internal rotation and external rotation ranges are measured in the supine position.

  0( baseline)

• Range of Motion

  Shoulder ROM is measured using a universal protractor(goniometer). Shoulder flection, extension, abduction, internal rotation and external rotation ranges are measured in the supine position.

  3th week

• Range of Motion

  Shoulder ROM is measured using a universal protractor(goniometer). Shoulder flection, extension, abduction, internal rotation and external rotation ranges are measured in the supine position.

  12th week

Secondary Outcomes (9)

• Shoulder Pain and Disability Index (SPADI)

  0( baseline)

• Shoulder Pain and Disability Index (SPADI)

  3th week

• Shoulder Pain and Disability Index (SPADI)

  12th week

• Modified Constant-Murley Score

  0( baseline)

• Modified Constant-Murley Score

  3th week

Study Arms (3)

VR group

ACTIVE COMPARATOR

VR-based exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. These individuals will use the Microsoft Kinect for Azure VR system in the virtual environment. They will play the registered games. These games will include purpose-oriented activities such as lying on the shelf and using bilaterally, which are intended to use the upper extremities of individuals with AC in daily life.

Other: virtual reality based exercises; Other: home exercises program

Conventional group

ACTIVE COMPARATOR

Individuals in the second group, who will be included in the traditional exercise group, will be included in the stretching and strengthening exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. The exercises will be performed by a physiotherapist working in the clinic and blind to the study.

Other: conventional physical therapy; Other: home exercises program

Control group

OTHER

In the third group, who will be included in the home exercise group, exercises will be taught to the patient and will be applied for half an hour a day, 5 days a week for a total of 3 weeks.

Other: home exercises program

Interventions

virtual reality based exercises OTHER

play VR games

VR group

conventional physical therapy OTHER

streching and strengthening exercises

Conventional group

home exercises program OTHER

home exercises

Control group; Conventional group; VR group

Eligibility Criteria

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

You may qualify if:

• Aged between 18-65
• Clinical diagnosis of adhesive capsulitis
• Patients with loss of range of motion in a capsular pattern (external rotation \>abduction \> internal rotation)
• Participant signed informed consent

You may not qualify if:

• Surgery on the upper extremity or trunk
• Upper extremity injury in the last 6 months
• Injections in the shoulder area in the last 6 months
• Systemic or local infection of shoulder
• Uncontrolled hypertension
• Inability to cooperate VR
• Patient with malignancy
• Neurological disease

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Ahi Evran University

Kirşehir, City Centre, 40100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Sveistrup H, McComas J, Thornton M, Marshall S, Finestone H, McCormick A, Babulic K, Mayhew A. Experimental studies of virtual reality-delivered compared to conventional exercise programs for rehabilitation. Cyberpsychol Behav. 2003 Jun;6(3):245-9. doi: 10.1089/109493103322011524.

  PMID: 12855079 BACKGROUND

• Lee SH, Yeh SC, Chan RC, Chen S, Yang G, Zheng LR. Motor Ingredients Derived from a Wearable Sensor-Based Virtual Reality System for Frozen Shoulder Rehabilitation. Biomed Res Int. 2016;2016:7075464. doi: 10.1155/2016/7075464. Epub 2016 Aug 23.

  PMID: 27642600 BACKGROUND

• Gumaa M, Rehan Youssef A. Is Virtual Reality Effective in Orthopedic Rehabilitation? A Systematic Review and Meta-Analysis. Phys Ther. 2019 Oct 28;99(10):1304-1325. doi: 10.1093/ptj/pzz093.

  PMID: 31343702 BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Basak Cigdem KARACAY, assist prof

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basak Cigdem KARACAY, assist prof

CONTACT

+90 386 280 39 00; basak.cigdemkaracay@ahievran.edu.tr

Basak Cigdem KARACAY, assist prof

CONTACT

basak.cigdemkaracay@ahievran.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and outcomes assesor will be different persons
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor, assistant prof

Model Details: Patients will be randomly divided into 3 groups. They will be selected by simple random sampling using the closed envelope method. In the first group, will be included in a VR-based exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. These individuals will use the Microsoft Kinect for Azure VR system in the virtual environment. In the second group, will be included in the traditional exercise group, will be included in the stretching and strengthening exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. In the third group, who will be included in the home exercise group, exercises will be taught to the patient and will be applied for half an hour a day, 5 days a week for a total of 3 weeks.

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: January 15, 2024
• Primary Completion: July 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)