Effects of Whole Body Vibration in Parkinson's Disease Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Changes from week 9 gait functionality at 22 weeks (follow up period)
研究概览
简要总结
The goal of this clinical trial is to know the effects of an intervention in Parkinson's disease symptoms. The main question it aims to answer are:
- Is whole body vibration able to reduce rigidity in Parkinson's participants?
- Can whole body vibration modify gait abilities and other Parkinson's symptoms? Participants (subjects with Parkinson's disease) will do habitual therapy treatment. Experimental group will also carry out whole body vibration sessions and control group will do placebo whole body vibration sessions.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson Disease, in phase I and II according to Hoehn & Yahr phases.
- •Able to maintain independently standing position.
- •Able to understand instructions and score >24 in Minimental Test.
排除标准
- •Changes in pharmacological treatment for PD symptoms during the study.
- •Recent injuries in the last 12 weeks in lower limbs or trunk.
- •Other neurological conditions not related to Parkinsonism.
结局指标
主要结局
Changes from week 9 gait functionality at 22 weeks (follow up period)
时间窗: Week 22
This outcome will be measured with the Modified Emory Functional Ambulation Profile. This scale assesses functional ambulation in terms of assistance and time under five different environmental conditions. Since time (seconds) if the main measure, there is not top score and the higher the score, the worse is the performance.
Change from baseline muscle tone at 9 weeks
时间窗: Week 9
Muscle tone will be measured using Myoton Pro (Hz) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Change from baseline muscle stiffness at 9 weeks
时间窗: Week 9
Muscle stiffness will be measured using Myoton Pro (N/m) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Change from week 9 muscle tone at 22 weeks (follow up period)
时间窗: Week 22
Muscle tone will be measured using Myoton Pro (Hz) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Change from week 9 muscle elasticity at 22 weeks (follow up period)
时间窗: Week 22
Muscle elasticity will be measured using Myoton Pro (logarithmic decrement) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Change from baseline muscle elasticity at 9 weeks
时间窗: Week 9
Muscle elasticity will be measured using Myoton Pro (logarithmic decrement) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Change from week 9 muscle stiffness at 22 weeks (follow up period)
时间窗: Week 22
Muscle stiffness will be measured using Myoton Pro (N/m) in the following sites: plantar fascia, Achilles tendon, soleus, gastrocnemius, erector spinae (L3-L4, T12-L1, T8-T9,T3-T4 and C7-T1) , transversus abdominus, rectus femoris, infrapatellar tendon and anterior tibialis . Measures will be taken twice bilaterally.
Changes from baseline gait functionality at 9 weeks
时间窗: Week 9
This outcome will be measured with the Modified Emory Functional Ambulation Profile. This scale assesses functional ambulation in terms of assistance and time under five different environmental conditions. Since time (seconds) if the main measure, there is not top score and the higher the score, the worse is the performance.
次要结局
- Changes from baseline reactive balance at 9 weeks(Week 9)
- Changes from week 9 thoracic kyphosis at 22 weeks (follow up period)(Week 22)
- Changes from week 9 freezing of gait at 22 weeks (follow up period)(Week 22)
- Changes from baseline aspects of quality of life at 9 weeks(Week 9)
- Changes from week 9 aspects of quality of life at 22 weeks (follow up period)(Week 22)
- Changes from week 9 reactive balance at 22 weeks(Week 22)
- Changes from baseline freezing of gait at 9 weeks(Week 9)
- Changes from baseline thoracic kyphosis at 9 weeks(Week 9)
研究者
Paula González García
Principal investigator
University of Seville