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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-28

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rotator Cuff Impingement Syndrome Rotator Cuff Tears Rotator Cuff Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional physical therapy

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.

Group Type ACTIVE_COMPARATOR

conventional physical therapy training

Intervention Type OTHER

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.

Virtual reality (VR)

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.

Group Type EXPERIMENTAL

Virtual Reality (VR) training

Intervention Type DEVICE

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.

Interventions

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conventional physical therapy training

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.

Intervention Type OTHER

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 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No