Effect of Virtual Reality on Upper Extremity Function Post-operative Rotator Cuff Repair

Rotator Cuff Tears Clinical Trial

Official title:

The Effect of Virtual Reality Intervention and Its Impact on Upper Extremity Function in Patients With Post-operative Rotator Cuff Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246305
• Other study ID #: VR on rotator cuff repair
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2024
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: Ahmed El Melhat, PhD
• Phone: 01112595022
• Email: ahmed.elmelhat[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to investigate the effect and the impact of performing virtual reality intervention on upper extremity function in patients with post-operative rotator cuff repair. The main question that it aims to answer is:

Does the application of virtual reality intervention improves upper extremity function in patients with post-operative rotator cuff repair.

Participants will be randomized into 2 groups: the control group receiving conventional physical therapy intervention and the experimental group receiving the virtual reality intervention.

Description:

Rotator cuff tears are one of the most common disorders of the shoulder that result in shoulder pain and dysfunction. It affects about 30% of individuals that are older than 60 years. The conservative management is the first-line treatment for a rotator cuff tear, but a surgical rotator cuff repair (RCR) is required if the conservative management failed. Post-operative rehabilitation requires up to 12 weeks. But, Virtual Reality (VR) intervention is emerging as a viable alternative for musculoskeletal rehabilitation of the upper limb. Unlike in neuro-rehabilitation, VR is still poorly used in orthopedic rehabilitation. Thus, the investigators hypothesize that performing virtual reality intervention will improve the upper extremity function in patients with post-operative rotator cuff repair.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Older than 18 years old and younger than 70 years old, and referred by the Adult Orthopedic Department with arthroscopic RC repair of a non-retracted isolated full-thickness supraspinatus tear with maximum 5 days post operation.

2. Poor response to initial non-operative treatment.

Exclusion Criteria:

1. Large-sized RC tears (3-5 cm),

2. Massive or irreparable RC tears,

3. Anteroinferior labral (Bankart) or superior labrum anterior to posterior lesions,

4. Severe glenohumeral osteoarthritis,

5. Adhesive capsulitis, or

6. Previous surgery on the affected shoulder

7. Re-tears of the RC.

8. Indication for revision RCR

9. Severe neurological deficits

10. Infection in the affected shoulder

11. Blindness and/or illiteracy

Related Conditions & MeSH terms

• Rotator Cuff Impingement Syndrome
• Rotator Cuff Injuries
• Rotator Cuff Tears
• Shoulder Impingement Syndrome

Intervention

Other:
• conventional physical therapy training
conventional therapy rehabilitation program is divided into three phases: on-brace, off-brace, and active mobilization. The on-brace phase (post-op 0-6 weeks) mainly consists of low-intensity whole-body exercises with shoulder girdle, elbow, and hand mobilization exercises on the affected side. The off-brace phase (post-op 6-9 weeks) consists of passive shoulder ROM exercises using an exercise stick and an early scapular stabilization exercise. The active mobilization phase (post-op 9-12 weeks) consists of both active and passive shoulder ROM , strengthening exercise with progressive resistance, and scapular stabilization exercises. The intervention is done 3 times per week for 12 weeks.

Device:
• Virtual Reality (VR) training
During the on-brace phase (0-6 weeks), participants in this group will use the program as performed in the control group. During the off-brace (6-9 weeks post-op) and active mobilization phases (9-12 weeks post-op), participants will use the Virtual Reality machine. this program involves warming up and down stretching exercises and exercise training that includes bilateral shoulder elevation, boxing, bowling and tennis games accompanied by avatar. The intervention is done 3 times per week for 12 weeks.

Locations

Country	Name	City	State
Egypt	Ahmed ElMelhat [aelmelhat]	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Correia FD, Molinos M, Luis S, Carvalho D, Carvalho C, Costa P, Seabra R, Francisco G, Bento V, Lains J. Digitally Assisted Versus Conventional Home-Based Rehabilitation After Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Mar 1;101(3):237-249. doi: 10.1097/PHM.0000000000001780. — View Citation

Gutierrez-Espinoza H, Araya-Quintanilla F, Pinto-Concha S, Zavala-Gonzalez J, Gana-Hervias G, Cavero-Redondo I, Alvarez-Bueno C. Effectiveness of supervised early exercise program in patients with arthroscopic rotator cuff repair: Study protocol clinical trial. Medicine (Baltimore). 2020 Jan;99(4):e18846. doi: 10.1097/MD.0000000000018846. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder function with disabilities of arm, shoulder and hand	in numbers, it ranges from 0 to 100 with 0 being the lowest and 100 the highest. The higher the score means the better outcome	Measured at baseline, after 6 weeks, and after 12 weeks
Secondary	The Numerical Pain Intensity Rating Scale	in numbers, it ranges from 0 to 10 with 0 being the lowest and 10 being the highest. The higher the score means the better outcome	Measured at baseline, after 6 weeks, and after 12 weeks
Secondary	Active and passive range of motion using goniometer	in degrees	Measured at baseline, after 6 weeks, and after 12 weeks
Secondary	Isometric muscle test by Handheld Dynamometer	in numbers, it ranges from 0 to 5 with 0 being the lowest and 5 the highest. The higher the score means the better outcome	Measured at baseline, after 6 weeks, and after 12 weeks

External Links

•   A randomized controlled trial of postoperative rehabilitation using digital healthcare system after rotator cuff repair
•   Comparison of virtual reality exergaming and home exercise programs in patients with subacromial impingement syndrome and scapular dyskinesis: Short term effect
•   Post-operative rehabilitation using a digital healthcare system in patients who had undergone rotator cuff repair: protocol for a single-center randomized controlled trial
•   The Effects of Virtual Reality Exergaming on Pain, Functionality and Acromiohumeral Distance in Shoulder Impingement Syndrome Patients: A Randomized Controlled Study