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

Not Applicable

Recruiting

• Conditions: Rotator Cuff Impingement Syndrome; Rotator Cuff Injuries; Rotator Cuff Tears
• Interventions: Other: conventional physical therapy training; Device: Virtual Reality (VR) training

• Registration Number: NCT06246305
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-27
• Study Start: 2024-01-28
• Study First Submitted QC: 2024-02-04
• Last Update Submitted: 2024-02-04
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-05
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional physical therapy	conventional physical therapy training	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.
Virtual reality (VR)	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 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.

Primary Outcome Measures

Name	Time	Method
Shoulder function with disabilities of arm, shoulder and hand	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 Outcome Measures

Name	Time	Method
Active and passive range of motion using goniometer	Measured at baseline, after 6 weeks, and after 12 weeks	in degrees
The Numerical Pain Intensity Rating Scale	Measured at baseline, after 6 weeks, and after 12 weeks	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
Isometric muscle test by Handheld Dynamometer	Measured at baseline, after 6 weeks, and after 12 weeks	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

Trial Locations

Locations (1)

Ahmed ElMelhat [aelmelhat]; 🇪🇬 Cairo, Egypt