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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06246305
Enrollment
60
Registered
2024-02-07
Start date
2024-01-28
Completion date
2024-07-31
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Impingement Syndrome, Rotator Cuff Tears, Rotator Cuff Injuries

Keywords

rotator cuff repair, post-operative, upper extremity, function

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.

Interventions

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.

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

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

Eligibility

Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Shoulder function with disabilities of arm, shoulder and handMeasured at baseline, after 6 weeks, and after 12 weeksin numbers, it ranges from 0 to 100 with 0 being the lowest and 100 the highest. The higher the score means the better outcome

Secondary

MeasureTime frameDescription
The Numerical Pain Intensity Rating ScaleMeasured at baseline, after 6 weeks, and after 12 weeksin 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
Active and passive range of motion using goniometerMeasured at baseline, after 6 weeks, and after 12 weeksin degrees
Isometric muscle test by Handheld DynamometerMeasured at baseline, after 6 weeks, and after 12 weeksin numbers, it ranges from 0 to 5 with 0 being the lowest and 5 the highest. The higher the score means the better outcome

Countries

Egypt

Contacts

Primary ContactAhmed El Melhat, PhD
ahmed.elmelhat@cu.edu.eg01112595022
Backup ContactAseel El kawam, DPT
aseelkawam@gmail.com70656958

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026