CHANGES IN SPASTICITY, WIDESPREAD PRESSURE PAIN SENSITIVITY, AND BAROPODOMETRY AFTER DRY NEEDLING IN STROKE PATIENTS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Changes in spasticity before and after the intervention
研究概览
简要总结
Stroke is the leading cause of physical disability, particularly due to the presence of spasticity. Different needling techniques, including the use of Botulinum Toxin A are proposed for the management of spasticity. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. No study has investigated the effects of deep dry needling inserted into the targeted spastic musculature in patients with stroke. The investigators will conduct a randomized controlled trial investigating the effects of a single session of deep dry needling over the musculature of the leg on spasticity, widespread pressure pain sensitivity and plantar pressures (baropodometry) in individuals with chronic stroke. The investigators hypothesize that patients receiving a single session of dry needling would exhibit a greater reduction in spasticity and pressure sensitivity than those who will not receive the intervention.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-ever unilateral stroke;
- •hemiplegia resulting from stroke;
- •unilateral equinovarus gait with independent walk;
- •able to ambulate without supporting devices.
排除标准
- •recurrent stroke;
- •previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time, or with BTX-A in the previous 6 months
- •not independent in the basic activities of daily living
- •severe cognitive deficits;
- •progressive or severe neurologic diseases;
- •fear to needles;
- •any contraindication for dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.
结局指标
主要结局
Changes in spasticity before and after the intervention
时间窗: Baseline and immediate after the inetrvention
Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively will move the ankle in dorsal-flexion direction, back and forth at least 5 times and will evaluate the degree of resistance to the movement on a scale from 0-4. This outcome will take 1 minute approximately.
次要结局
- Changes in pressure pain sensitivity before and after the intervention(Baseline and immediate after the inetrvention)
- Changes in baropodometry outcomes before and after the intervention(Baseline and immediate after the inetrvention)
研究者
César Fernández-de-las-Peñas
PROFESSOR
Universidad Rey Juan Carlos