Effects of Whole Body Vibration in Parkinson's Disease Symptoms
- Conditions
- Parkinson Disease
- Interventions
- Other: Habitual TherapyDevice: Whole body VibrationDevice: Placebo whole body vibration
- Registration Number
- NCT05621031
- Lead Sponsor
- University of Seville
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 46
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PDControl Habitual Therapy This group will receive usual care (physical therapy) and placebo whole body vibration session. PDControl Placebo whole body vibration This group will receive usual care (physical therapy) and placebo whole body vibration session. PDExperimental Whole body Vibration This group will receive usual care (physical therapy) and whole body vibration sessions. PDExperimental Habitual Therapy This group will receive usual care (physical therapy) and whole body vibration sessions.
- Primary Outcome Measures
Name Time Method Changes from week 9 gait functionality at 22 weeks (follow up period) 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 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 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) 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) 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 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) 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 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.
- Secondary Outcome Measures
Name Time Method Changes from baseline reactive balance at 9 weeks Week 9 This outcome will be measure with the section of reactive balance assessment of the Balance Evaluation System Test (BESTest). This section includes 5 items that specifically measures reactive balance and compensatory responses in all directions. The scores ranges between 0 and 18, with a lower score reflecting worse reactive balance.
Changes from week 9 thoracic kyphosis at 22 weeks (follow up period) Week 22 The degree of thoracic kyphosis will be measure with the mobile application Goniometer Pro (degrees). The mobile will the placed at T1 and T12 and will measure the angle between them.
Changes from week 9 freezing of gait at 22 weeks (follow up period) Week 22 This outcome will be measured with the Freezing of Gait Questionary. This scale assesses the severity and the frequency of the episodes of freezing during gait. It also considers the relationship of these episodes with other gait and motor aspects.The scores ranges between 0 and 24, with a lower score less freezing episodes.
Changes from baseline aspects of quality of life at 9 weeks Week 9 This outcome will be measured with the Parkinson's Disease Questionnaire (PDQ-399). This questionnaire assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living. The scores ranges between 0 and 800, with a lower score reflecting better quality of life.
Changes from week 9 aspects of quality of life at 22 weeks (follow up period) Week 22 This outcome will be measured with the Parkinson's Disease Questionnaire (PDQ-399). This questionnaire assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living. The scores ranges between 0 and 800, with a lower score reflecting better quality of life.
Changes from week 9 reactive balance at 22 weeks Week 22 This outcome will be measure with the section of reactive balance assessment of the Balance Evaluation System Test (BESTest). This section includes 5 items that specifically measures reactive balance and compensatory responses in all directions. The scores ranges between 0 and 18, with a lower score reflecting worse reactive balance.
Changes from baseline freezing of gait at 9 weeks Week 9 This outcome will be measured with the Freezing of Gait Questionary. This scale assesses the severity and the frequency of the episodes of freezing during gait. It also considers the relationship of these episodes with other gait and motor aspects.The scores ranges between 0 and 24, with a lower score less freezing episodes.
Changes from baseline thoracic kyphosis at 9 weeks Week 9 The degree of thoracic kyphosis will be measure with the mobile application Goniometer Pro (degrees). The mobile will the placed at T1 and T12 and will measure the angle between them.
Trial Locations
- Locations (1)
Asociación de Enfermos de Parkinson de Sevilla
🇪🇸Sevilla, Spain