The Effect of Virtual Reality Intervention and Its Impact on Upper Extremity Function in Patients With Post-operative Rotator Cuff Repair
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Shoulder function with disabilities of arm, shoulder and hand
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Blindness and/or illiteracy
研究组 & 干预措施
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.
干预措施: conventional physical therapy training (Other)
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.
干预措施: Virtual Reality (VR) training (Device)
结局指标
主要结局
Shoulder function with disabilities of arm, shoulder and hand
时间窗: 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
次要结局
- Isometric muscle test by Handheld Dynamometer(Measured at baseline, after 6 weeks, and after 12 weeks)
- 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)
研究者
Ahmed ElMelhat
Principal investigator
Cairo University