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Clinical Trials/NCT06246305
NCT06246305
Recruiting
Not Applicable

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

Cairo University1 site in 1 country60 target enrollmentJanuary 28, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator Cuff Impingement Syndrome
Sponsor
Cairo University
Enrollment
60
Locations
1
Primary Endpoint
Shoulder function with disabilities of arm, shoulder and hand
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 28, 2024
End Date
July 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed ElMelhat

Principal investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

  • 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.
  • Poor response to initial non-operative treatment.

Exclusion Criteria

  • Large-sized RC tears (3-5 cm),
  • Massive or irreparable RC tears,
  • Anteroinferior labral (Bankart) or superior labrum anterior to posterior lesions,
  • Severe glenohumeral osteoarthritis,
  • Adhesive capsulitis, or
  • Previous surgery on the affected shoulder
  • Re-tears of the RC.
  • Indication for revision RCR
  • Severe neurological deficits
  • Infection in the affected shoulder

Outcomes

Primary Outcomes

Shoulder function with disabilities of arm, shoulder and hand

Time Frame: Measured at baseline, after 6 weeks, and after 12 weeks

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

Secondary Outcomes

  • Active and passive range of motion using goniometer(Measured at baseline, after 6 weeks, and after 12 weeks)
  • The Numerical Pain Intensity Rating Scale(Measured at baseline, after 6 weeks, and after 12 weeks)
  • Isometric muscle test by Handheld Dynamometer(Measured at baseline, after 6 weeks, and after 12 weeks)

Study Sites (1)

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