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Clinical Trials/NCT05621031
NCT05621031
Not yet recruiting
Not Applicable

Effects of Whole Body Vibration in Parkinson's Disease Symptoms

University of Seville1 site in 1 country46 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University of Seville
Enrollment
46
Locations
1
Primary Endpoint
Changes from week 9 gait functionality at 22 weeks (follow up period)
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
November 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paula González García

Principal investigator

University of Seville

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Changes from week 9 gait functionality at 22 weeks (follow up period)

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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