The Effectiveness of Taping Technique Versus Conventional Techniques in Prevention of Shoulder Injuries in Patients With Acute Stroke-A Prospective, Randomized, Interventional, Outcome Blinded (PROBE Design), Parallel Design Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 4
- 主要终点
- Pain: Visual Analog Scale
研究概览
简要总结
Background and Rationale: The most commonly seen disabilities in stroke patients are shoulder injuries such as shoulder pain, glenohumeral subluxation, spasticity of shoulder muscles, soft-tissue trauma, rotator cuff tears, and shoulder-hand syndrome.
Taping is widely used in the field of rehabilitation as both means of treatment and prevention of sports related injuries. Scarce information is available regarding the use of shoulder taping in preventing shoulder injuries in stroke patients. Aims:
To find out the effectiveness of taping technique with conventional treatment versus sham taping and conventional treatment in prevention of shoulder injuries in patients with acute stroke.
Hypothesis:
Taping technique with conventional treatment will be superior to conventional treatment alone in preventing shoulder injuries in patients with acute stroke.
Methods Research setting: Stroke unit, department of Neurology, Christian Medical College (CMC) Ludhiana, Punjab, India and College of Physiotherapy, CMC Ludhiana.
Study design: prospective, randomized, outcome blinded trial (PROBE design). Study period: Prospective for 18 months from May 2009 All stroke patients with upper limb weakness within 48 hours after the ictus and with Brunnstrom's stage of recovery 1 and 2 will be included in the study. Patients will be randomized into two groups using lottery method. The treatment arm group(Group I) include shoulder taping with conventional techniques that is(positioning, handling technique and passive range of motion exercises) and the control arm (Group II) include sham taping with conventional techniques with sham taping. A total of 80 patients in each group will be included. The plastic micropore and elastic adhesive tape will be used for taping the affected shoulder. The sham taping will be done using the same tapes but without stretching the concerned muscles and joints. The tapes will be changed every 3 days and will remain for 14 days. The outcome measures are as follows; Primary: Pain: Visual Analog Scale and Activities of daily living: Shoulder Pain and Disability Index (SPADI); Secondary: Range of motion: using a Goniometer. The outcome will be assessed by an independent physiotherapist who will be blinded to the clinical details. Patients will be followed-up at 14 days and 30 days. Statistical analyses will be done using SPSS software version 16.
详细描述
Background and Rationale:
Stroke is the second leading cause of death and a major cause of disability worldwide. Two-thirds of stroke deaths worldwide occur in developing countries. According to recent reports from India the incidence and 30-day case fatality rates are higher than the developed countries. In both rural and urban India there has been a rise in the non-communicable diseases like stroke and coronary artery disease. In developing countries the average age of stroke is 15 years less than that of developed countries.
It has been estimated that by 2021, the stroke related "disability adjusted life years" (DALY) would become 61 million, and 52 million would be in developing nations. According to recent studies 55-70% of stroke survivors become fully independent by one year and 7-16% remain completely disabled. Prominent residual spasticity occurs in 46% of patients.
Shoulder Injuries in Stroke The most commonly seen disabilities in stroke patients are shoulder injuries which are more common during sub-acute phase of stroke. Pain in the affected shoulder often referred to as hemiplegic shoulder pain, is a common complication. The other types of shoulder injuries include glenohumeral subluxation, spasticity of shoulder muscles, soft-tissue trauma, rotator cuff tears, and shoulder-hand syndrome or reflex sympathetic dystrophy. Shoulder injuries can negatively affect rehabilitation outcomes as good shoulder function is a pre-requisite for successful transfers, maintaining balance, performing activities of daily living and for effective hand function.
Biomechanics of shoulder injuries in stroke patients A stroke patient with upper limb weakness tends to place the arm in a resting position and this promotes shortening of the shoulder adductors and internal rotators, and the elbow, wrist and hand flexors. This habitual posturing of the upper limb can result in adaptive changes to muscle tissue that impede both passive and active joint movement.As motor power returns, the pattern of recovery may be imbalanced, with individual muscles developing strength at different rates or there may be increased tone in certain muscle groups. Imbalanced motor return and persistent attempts to move with increased activation of just one muscle group can pull the scapula and humerus into abnormal postures. When this posture is maintained, the resting length of the surrounding muscles may either shorten or lengthen, thereby disrupting the normal biomechanics of that joint. In addition in flaccid stage, the scapula assumes a depressed and downward rotated position, as the paretic serratus anterior and upper part of trapezius muscle no longer support the scapula. The combination of flaccid supportive musculature and a downward rotated scapula predisposes the head of humerus to undergo inferior subluxation relative to the glenoid fossa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke patients both ischemic and hemorrhagic with upper limb weakness within 48 hours after the ictus
- •Age over 18 years
- •Brunnstrom's stage of recovery 1 and 2
- •Patients willing to participate in the study
排除标准
- •Patients with Glasgow coma scale of <7
- •Patients on ventilator
- •Uncooperative patients
- •Patients having previous history of shoulder injury
- •Patients with Wernicke's aphasia
- •Patients having previous history of shoulder pain
- •Any previous history of skin allergy to tape
研究组 & 干预措施
Taping
The tri-pull method of taping was used.Taping was initiated by first applying three, two-inch wide and approximately ten-inch long, pieces of elastic adhesive tape strips. The first strip was applied from the mid-humerus deltoid tuberosity across the scapula. The second strip was applied from the deltoid tuberosity across the clavicle to the mid-clavicle, but before the supra-sternal notch. The third strip was placed from the deltoid tuberosity over the acromion process to the neck.
干预措施: Taping and Sham Taping (Procedure)
Sham Taping
This was done using the same tapes. Three strips of tapes were applied in same position without repositioning the joint. All other Physiotherapy measures like positioning, handling technique and range of motion exercises were equally done for both the groups.
干预措施: Sham Taping (Procedure)
结局指标
主要结局
Pain: Visual Analog Scale
时间窗: 14 days and 30 days
Visual analog scale (VAS) is an 11-point scale displayed on a 100 mm horizontal line, ranging from 0 ("No Pain") to 100 ("Worst Pain Imaginable") Shoulder pain and disability index (SPADI) is a 13-item questionnaire that consists of 2 subscales for pain (5 items) and disability (8 items), which is scored by taking an average of the 2 subscales. Scores range from 0 to 100, with higher scores indicating greater pain and disability
次要结局
- Passive Range of Motion (ROM)(14 days and 30 days)
