Effects of Dry Needling on Function, Muscle Tone and Quality of Life in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- 6 minute walk test
研究概览
简要总结
Hypothesis: Dry needling in lower limbs produces a change in function (assessed by the 6 minute walk test, timed up and go, 10 meter walk test and unified scale for Parkinson's disease) and muscle tone (assessed by tonometry and the modified of Modified Ashworth scale(MMAS)) in patients with Parkinson's disease.
The main objective of this study is to analyze the effect of dry needling on function and muscle tone in subjects with Parkinson disease.
The secondary objective is to analyze the longterm effects of dry needling on function and muscle tone in subjects with Parkinson disease.
详细描述
Methods:
It is a double-blinded randomized clinical trial where subjects are patients from Zaragoza and have been diagnosed with Parkinson´disease by a neurologist.
Inclusion criteria:
- Patients diagnosed with Parkinson by a neurologist.
- Age: 50 - 90 years.
- Presence of Hypertonia according to: MMAS score > 1 during movement of ankle dorsiflexion or knee flexion and extension.
Exclusion criteria:
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)
盲法说明
Masking is with sham dry needling, simulating to insert the needle, so no real masking 100%
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Parkinson by a neurologist
- •Age: 50 - 90 years
- •Presence of Hypertonia according to: MMAS score > 1 during movement of ankle dorsiflexion or knee flexion and extension
排除标准
- •Degenerative diseases that may affect the results.
- •Presence of fixed contractures.
- •Fear of needles
- •No tolerance to pain caused by dry needling
- •No commitment to continuity
结局指标
主要结局
6 minute walk test
时间窗: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
It measures the maximum distance that the subject is able to travel in 6 minutes. It allows to obtain the speed of walking.
10 meter walk test
时间窗: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
It used to assess walking speed in meters/second (m/s) over a short distance
Timed up and go test
时间窗: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention)
It measures patient mobility. The patient should get up from a chair with armrests, walk three meters, turn on himself, step back three meters and sit back down. If the patient takes less than 10s, it is considered normal mobility and more than 20s reduced mobility
次要结局
- Modified Modified Ashworth score(Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention))
- Tonometry (measurement of muscle tone with a device)(Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up (at 1 week after intervention))
- Unified Parkinson's Disease Rating Scale(Change between baseline (immediately before intervention) and follow-up at 1 week after intervention)