An interventional study of Whole body Vibration and Habitual Therapy in Parkinson Disease, sponsored by University of Seville. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-11-17.
Sponsored by University of Seville · Not applicable, Interventional, and Treatment
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:
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 46 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Seville is the lead sponsor of 127 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
This group will receive usual care (physical therapy) and whole body vibration sessions.
Device: Whole body Vibration · Other: Habitual Therapy
This group will receive usual care (physical therapy) and placebo whole body vibration session.
Other: Habitual Therapy · Device: Placebo whole body vibration
Whole body vibration will be administered with a vibration platform (Power Plate Move). Subjects will do several exercises (squats and steps) whilst on the platform, set at these parameters: frequency 30 Hz; amplitude: 2 mm; 1 min activation; 1 min rest, 5 activations. 15 sessions will be carried out (2/week).
Physical therapy will be administered to all study subjects. Experimental group will perform their session the same day that the experimental intervention.
Placebo whole body vibration will be administered with a vibration platform (Power Plate Move). Subjects will do several exercises (squats and steps) whilst on the platform. The platform will only be working for 3 seconds (parameters: frequency 30 Hz; amplitude: 2 mm) and after 3 seconds, the vibration will stop. Same as experimental group, there will be 1 min placebo activation; 1 min rest, 5 activations. 15 sessions will be carried out (2/week).
Change from baseline muscle tone at 9 weeks
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.
Time frame: Week 9
Change from baseline muscle stiffness at 9 weeks
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.
Time frame: Week 9
Change from baseline muscle elasticity at 9 weeks
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.
Time frame: Week 9
Change from week 9 muscle tone at 22 weeks (follow up period)
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.
Time frame: Week 22
Change from week 9 muscle stiffness at 22 weeks (follow up period)
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.
Time frame: Week 22
Change from week 9 muscle elasticity at 22 weeks (follow up period)
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.
Time frame: Week 22
Changes from baseline gait functionality at 9 weeks
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.
Time frame: Week 9
Changes from week 9 gait functionality at 22 weeks (follow up period)
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.
Time frame: Week 22
Changes from baseline thoracic kyphosis at 9 weeks
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.
Time frame: Week 9
Changes from week 9 thoracic kyphosis at 22 weeks (follow up period)
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.
Time frame: Week 22
Changes from baseline aspects of quality of life at 9 weeks
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.
Time frame: Week 9
Changes from week 9 aspects of quality of life at 22 weeks (follow up period)
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.
Time frame: Week 22
Changes from baseline freezing of gait at 9 weeks
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.
Time frame: Week 9
Changes from week 9 freezing of gait at 22 weeks (follow up period)
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.
Time frame: Week 22
Changes from baseline reactive balance at 9 weeks
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.
Time frame: Week 9
Changes from week 9 reactive balance at 22 weeks
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.
Time frame: Week 22
Age
Years
Time frame: Baseline
Height
Cm
Time frame: Baseline
Weight
Kg
Time frame: Baseline
Time since Parkinson disease diagnosis
Years and months
Time frame: Baseline
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University of Seville