An interventional study of conventional physical therapy training and Virtual Reality (VR) training in Rotator Cuff Impingement Syndrome, Rotator Cuff Tears and Rotator Cuff Injuries, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
304 studies on the registry are indexed under Shoulder Impingement Syndrome; 55 are open to participants now.
This study's planned enrollment of 60 is above the median of 54 across 261 interventional studies indexed under Shoulder Impingement Syndrome.
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Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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.
Other: conventional physical therapy 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.
Device: Virtual Reality (VR) 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.
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.
Shoulder function with disabilities of arm, shoulder and hand
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
Time frame: Measured at baseline, after 6 weeks, and after 12 weeks
The Numerical Pain Intensity Rating Scale
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
Time frame: Measured at baseline, after 6 weeks, and after 12 weeks
Active and passive range of motion using goniometer
in degrees
Time frame: Measured at baseline, after 6 weeks, and after 12 weeks
Isometric muscle test by Handheld Dynamometer
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
Time frame: Measured at baseline, after 6 weeks, and after 12 weeks
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