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

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Cairo University (CU)

Status

Enrolling

Conditions

Rotator Cuff Impingement Syndrome
Rotator Cuff Injuries
Rotator Cuff Tears

Treatments

Other: conventional physical therapy training
Device: Virtual Reality (VR) training

Study type

Interventional

Funder types

Other

Identifiers

NCT06246305
VR on rotator cuff repair

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

19 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Conventional physical therapy
Active Comparator group
Description:
The 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. In this phase, exercises are done of three sets with 10 repetitions per day. 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 using TheraBand, and scapular stabilization exercises. During the off-brace and active mobilization phases, exercises are done of 3-5 sets of exercises with 10 repetitions per day.
Treatment:
Other: conventional physical therapy training
Virtual reality (VR)
Experimental group
Description:
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 includes warming and cooling periods with posterior, anterior and inferior capsule stretching and pectoral muscle stretching. Exercise training includes bilateral shoulder elevation, boxing, bowling and tennis games accompanied by avatar. Resistance training is progressed in the active mobilization phase using TheraBand.
Treatment:
Device: Virtual Reality (VR) training

Trial contacts and locations

1

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Central trial contact

Aseel El kawam, DPT; Ahmed El Melhat, PhD

Data sourced from clinicaltrials.gov

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