Clinical trial NCT06246305: Effect of Virtual Reality on Upper Extremity Function Post-operative Rotator Cuff Repair
Official title: The Effect of Virtual Reality Intervention and Its Impact on Upper Extremity Function in Patients With Post-operative Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Impingement Syndrome
Rotator Cuff Tears
Rotator Cuff Injuries
Keywords: rotator cuff repair
post-operative
upper extremity
function
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into one of the 2 groups: the control group receiving the conventional physical therapy intervention or to the experimental group receiving virtual reality intervention
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Shoulder function with disabilities of arm, shoulder and hand
timeFrame: Measured at baseline, after 6 weeks, and after 12 weeks
Secondary outcomes:
measure: The Numerical Pain Intensity Rating Scale
timeFrame: Measured at baseline, after 6 weeks, and after 12 weeks
measure: Active and passive range of motion using goniometer
timeFrame: Measured at baseline, after 6 weeks, and after 12 weeks
measure: Isometric muscle test by Handheld Dynamometer
timeFrame: Measured at baseline, after 6 weeks, and after 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed ElMelhat [aelmelhat]
Study officials:
affiliation: Cairo University
name: Ahmed El Melhat, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.