The Effect of Cupping on Spasticity and Function of the Lower Extremity During Rehabilitation After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
Physical therapists use dry static cupping for the treatment of many conditions, including spasticity for patients post-stroke. While research better describes the effects of dry static cupping for patients with orthopedic conditions, information is lacking on central conditions, such as stroke and resulting spasticity.
详细描述
Cupping is an ancient alternative medicine. A common form of cupping, called dry static cupping, involves creating negative pressure inside a therapeutic cup. The cup is then placed on the skin, creating a light suction effect. In Eastern Medicine, cupping has been used to treat a variety of diseases. More recently, in Western society, cupping has been used after injury, and among other effects, has been found to improve blood volume and tissue oxygenation to an area. These effects have originally been thought to be peripheral in nature, occurring at the cupping site, hence, why cupping has been used for treatment for conditions like carpal tunnel syndrome, spinal pain, knee osteoarthritis, and other musculoskeletal conditions.
However, a recent systematic review found cupping to be beneficial for rehabilitation after stroke. These conclusions raise the question of a possible mechanism for cupping to improve impairments related to the central nervous system, such as spasticity after stroke. However, many of the studies to date have serious methodological flaws that limit the direct causation of cupping to the reduction of spasticity. As well, the majority of studies only involve the upper extremity. No study has yet looked at the therapeutic effects of dry static cupping on lower extremity spasticity reduction after stroke.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The physical therapist providing the standard physical therapy treatment and the outcomes assessment will be masked to group allocation. However, the therapist administering the cupping and placebo cupping treatments will not be masked to group allocation.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-80
- •Acute stroke (within 6 months of stroke), with spasticity & hemiparesis of LE
- •Referred by doctor for rehabilitation for a stroke-related condition
- •Attending Ascension Rehabilitation of Joliet for rehabilitation
- •Able to read or verbally understand English or Spanish
排除标准
- •Absent sensation of the areas to be cupped
- •Significant cognitive impairment
- •Pregnancy
- •Prescription anticoagulant medications
- •Blood clotting disorder
- •Uncontrolled hypertension
- •Uncontrolled diabetes
- •Open wounds within the cupping area
- •Current DVT
- •Hematoma over the cupping area
- •Fracture over the cupping area
- •Active cancer within the cupping area
- •Current use of Baclofen
- •Current use of Botox
- •Current use of an anti-spasticity medication
研究组 & 干预措施
Cupping group
This group (arm) will receive the dry static cupping intervention, along with the standard physical therapy treatment.
干预措施: Dry Static Cupping (Other)
Cupping group
This group (arm) will receive the dry static cupping intervention, along with the standard physical therapy treatment.
干预措施: Standard physical therapy treatment (Other)
Placebo cupping group
This group (arm) will receive a placebo-form of cupping (low, and non-therapeutic pressure amount in the cups), along with the standard physical therapy treatment.
干预措施: Standard physical therapy treatment (Other)
Placebo cupping group
This group (arm) will receive a placebo-form of cupping (low, and non-therapeutic pressure amount in the cups), along with the standard physical therapy treatment.
干预措施: Placebo cupping (Other)
结局指标
主要结局
Modified Ashworth Scale
时间窗: At enrollment and then at 1, 2, and 3 months of treatment.
The Modified Ashworth Scale measures spasticity on a 0-4 ordinal scale, with higher scores indicating greater spasticity. The grade is determined by passively moving a joint/muscle through a high velocity unidirectional quick stretch. For this study, spasticity will be assessed for the hip adductors and hamstrings of the affected side. Equipment: Mat Table Administration: Patient is positioned in supine on a mat table. For Hip Adduction: Physical therapist passively moves the affected lower extremity into hip abduction quickly keeping the knee in extension. For Hamstrings: Physical therapist passively moves the hip to 90 degrees of flexion and allows the knee to bend into knee flexion. Then, the therapist passively moves the affected knee into extension quickly.
次要结局
- Six-Minute Walk Test (6MWT)(At enrollment and then at 1, 2, and 3 months of treatment.)
- Timed Up and Go (TUG) Test(At enrollment and then at 1, 2, and 3 months of treatment.)
- Berg Balance Scale (BBS)(At enrollment and then at 1, 2, and 3 months of treatment.)
研究者
Scott Getsoian
Physical Therapist
Ascension Health