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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06246305
Other study ID # VR on rotator cuff repair
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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